Studies & Research - Trigeminal Neuralgia Association Australia

Posted on September 21, 2023September 29, 2023 by Lynette Donnelly — Leave a comment

Stem Cell Therapy for Trigeminal Neuralgia

There has been some interaction on our Facebook page referencing Stem Cell Therapy for trigeminal neuralgia. Over the years there has been some controversial claims on the subject, with medical professionals choosing which side they stood on the issue, however this is a quickly developing area of medical science.

In this article we provide educational content to help you understand the science and potential applications.

Current research is very much focused on the auto immune system and activating the bodies own healing capacities to cure invasive conditions like cancer.

So what are stem cells?

Stem cells are immature cells that have the ability to renew and differentiate to form different types of cells; in other words, they are cells that have the ability to develop into various kinds of other types of cells. For example, blood cells, nerve cells, immune cells etc. Human stem cells can be found in adult bone marrow or human embryos.

Australia is currently watching with amazement, one of our own prominent melanoma specialist treating himself with ground breaking novel treatments to try and beat a life ending brain tumour.

Stem cell therapy is not a new concept and has been researched for more than 15 years and below are highlighted two studies covering the subject.

A preliminary report on stem cell therapy for neuropathic pain in humans

Mesenchymal stem cells (MSCs) have been shown in animal models to attenuate chronic neuropathic pain. This preliminary study investigated if: i) injections of autologous MSCs can reduce human neuropathic pain and ii) evaluate the safety of the procedure.

Stem Cell Therapy and Its Significance in Pain Management

Stem Cell Therapy in Trigeminal Neuralgia

Trigeminal NP encompasses variable states of diagnosis, this includes trauma resulting in maxillofacial NP, odontalgia which is atypical, and burning mouth syndrome. Trigeminal NP is considered to be a localized pain. Thereby, its patient population forms an ideal group to investigate the innovative novel therapy.

Stem cell therapy

The below article link has been published via Stem Cell Care India

Pros and Cons of Using Various Stem Cells

The below download is an Australian Study conducted by E Russell Vickers, Elisabeth Karsten, John Flood, and Richard Lilischkis

A preliminary report on stem cell therapy for neuropathic pain in humans

The psychological and mental health of anyone considering stem cell therapy is also a consideration which the article below explores.

Psychological Issues for Patients Undergoing Stem Cell Therapy and Regenerative Medicine

Stem cell treatments and regulation – a quick guide for Australian consumers

DISCLAIMER INFO: In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug.20 June 2019

Another Trigeminal Neuralgia Patient Helped

By Chris Centeno, MD

Published on Oct 30, 2021

Credit: Shutterstock

At Regenexx, we’re constantly expanding the number and type of patients we can help with precision orthobiologic procedures. While that occurs at all of our sites, our primary new treatment research site is our Colorado HQ. There we’ve been developing a new procedure to help patients with Trigeminal Neuralgia. This is very different than the Trigeminal Neuralgia stem cell treatment scams popping up at local integrative medicine practices. Let’s dig in.

What Is Trigeminal Neuralgia? How Is It Usually Treated?

Imagine that you wake up one day with severe facial pain. The pain is just like a severe toothache but in your eye, cheek, or jaw and nothing makes it go away. In fact, after a few months like this, with most doctors not knowing how to help, you’re considering the possibility that suicide could be the answer. That’s Trigeminal Neuralgia in a nutshell.

There are specialized nerves that exit the skull at various places called “Cranial nerves”. They come directly off of the brain or brainstem, unlike all other nerves that come off the spinal cord. They’re numbered 1-12 and the fifth nerve is called “Trigeminal”. It’s responsible for taking sensations from the face to the brain.

The Trigeminal nerve has three branches, the Mandibular (jaw), Ophthalmic (eye), and Maxillary (cheek):

Credit: Shutterstock

These branches from top to bottom are also known as V1, V2, and V3.

When one or more of these nerves chronically misfires, this can cause chronic severe pain in the face, teeth, or nose. This pain is usually more intense than when other nerves in the body misfire because there’s less pain control circuitry for Cranial nerves.

The treatments are very invasive and involve either focused radiation to destroy the nerve (gamma knife or radiosurgery) or microsurgery to move an artery that may be aggravating the nerve (microvascular decompression). Both have high complication rates and aren’t always successful.

The New Orthobiologic Trigeminal Neuralgia Treatment

We’ve known for some time that platelet growth factors can help nerve function. In fact, we’ve published a paper suggesting that Platelet Lysate (the growth factors stripped from platelets in plasma) may help chronically irritated low back nerves. Others have published research showing that PRP can help the Median nerve in Carpal Tunnel Syndrome patients (4-9).

Hence, it wasn’t too far a stretch to think that if we developed a precise way to inject the Trigeminal nerve with Platelet Lysate (or PRP) that these patients may be helped as well without these invasive and destructive procedures. While I’ve treated some of these patients as well who also have Craniocervical Instability, Jason Markle, M.D. at our Colorado HQ really took the lead on this advancement. I’m proud to say that Jason has now begun to dial in this new promising therapy.

Perc-TGN Procedure

The new treatment, known as the Perc-TGN procedure is percutaneous hydrodissection of the Trigeminal nerve using Platelet Lysate. This involves first isolating platelets from the patient’s blood and creating a growth factor rich plasma in our lab. Then the doctor precisely places this mix using x-ray and ultrasound guidance around the problematic branches of the nerve. This both breaks up local scar tissue and provides growth factors for the nerve to help it heal.

Does Perc-TGN Work?

Let one of the first patients to receive this new procedure tell you about their journey:

“After a year of misdiagnosis, I was correctly diagnosed with Trigeminal Neuralgia (TN) in 2015. TN is often called the “Suicide Disease”, because of the level of pain and no cure. The TN nerve on the left side of my face was damaged, because a blood vessel was in constant contact and had worn away the Myelin Sheath, which protects the nerve. With every pulse I experienced excruciating pain. After seeing multiple neurologists and neurosurgeons in December 2018, I had Radiosurgery on the damaged nerve. This doesn’t heal the nerve, but blocks the pain signal from the nerve to the brain. The hope was that I would be pain-free for up to three years. After 13 months in February 2020, the pain returned like a freight train.

The next step would have been Microvascular Decompression Surgery. The possible complications from this surgery include a stroke or loss of hearing or sight on the side where the damaged TN nerve is located. While they have success, it’s not known how long one might be pain free. Not excited about this option, God another door opened for me.

Today there are lots of stem cell clinics. Although Centeno-Schultz in Broomfield, Colorado pioneered stem cell and PRP. Dr. Jason Markle, one of the doctors at the clinic, decided to do a small trial with me. I have had three Plasma Rich Platelets (PRP) injections over and around the damaged Trigeminal nerve. Because I was patient number one with PRP for TN at the clinic, each procedure was slightly modified. Initially, I had about three months free from pain after each procedure. It was explained, the PRP, if correctly placed, pushes the nerve and blood vessel apart and then initiates healing. It was expected after a period of time, the nerve and blood vessel would come in contact once again causing pain. When this occurred, I would have another PRP treatment.

I’m ecstatic to say, PRP is the answer to my prayers. It’s been 10½ months since my last PRP. NO PAIN for 10½ months and counting! When there’s no pain, you can easily forget that TN was ever an issue! NO PAIN whatsoever. I’m praying the nerve and blood vessel will stay in place where they belong… apart from each other. If the pain reoccurs, you can be sure I’ll schedule another treatment with Dr. Markle.”

Beware of Trigeminal Neuralgia Stem Cell Treatment Scams

This treatment approach will only work if the doctor has the skill set to use ultrasound and x-ray imaging to target these very difficult to reach areas where the Trigeminal nerve is being irritated. That takes years of specialized training that just isn’t available at your local chiropractic or integrative medicine clinic where there’s usually a nurse or poorly trained physician performing the procedures. Precision placement using advanced imaging guidance is everything in this procedure.

While you, like this patient above, may have heard about a local office offering to treat Trigeminal Neuralgia with stem cells, that’s almost always a scam. First, the birth tissues they’re using have no living and functional stem cells. Our research lab proved that in our recent publication in the American Journal of Sports Medicine (10). Second, this treatment won’t work if an alternative medicine clinic gives you an IV treatment (in the vein in your arm).

The upshot? It’s great to see that the physicians at Regenexx HQ in Colorado continue to push the envelope of what’s possible with precision ortho-biologic procedures. The new Perc-TGN procedure is a big deal as these patients in severe pain have few good options.

References:

(1) Centeno C, Markle J, Dodson E, et al. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017;4(1):38. doi:10.1186/s40634-017-0113-5

(2) Sowa Y, Kishida T, Tomita K, Adachi T, Numajiri T, Mazda O. Involvement of PDGF-BB and IGF-1 in activation of human Schwann cells by platelet-rich plasma. Plast Reconstr Surg. 2019 Aug 27. doi:10.1097/PRS.0000000000006266

(3) Sánchez M, Anitua E2, Delgado D, Sanchez P, Prado R, Orive G, Padilla S. Platelet-rich plasma, a source of autologous growth factors and biomimetic scaffold for peripheral nerve regeneration. Expert Opin Biol Ther. 2017 Feb;17(2):197-212. doi:10.1080/14712598.2017.1259409

(4) Senna MK, Shaat RM, Ali AAA. Platelet-rich plasma in treatment of patients with idiopathic carpal tunnel syndrome. Clin Rheumatol. 2019 Aug 16. doi: 10.1007/s10067-019-04719-7.

(5) Sowa Y, Kishida T, Tomita K, Adachi T, Numajiri T, Mazda O. Involvement of PDGF-BB and IGF-1 in activation of human Schwann cells by platelet-rich plasma. Plast Reconstr Surg. 2019 Aug 27. doi: 10.1097/PRS.0000000000006266.

(6) Shen YP, Li TY, Chou YC, Ho TY, Ke MJ, Chen LC, Wu YT1. Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial. J Tissue Eng Regen Med. 2019 Jul 31. doi: 10.1002/term.2950.

(7) Güven SC, Özçakar L, Kaymak B, Kara M, Akıncı A. Short-term effectiveness of platelet-rich plasma in carpal tunnel syndrome: A controlled study. J Tissue Eng Regen Med. 2019 May;13(5):709-714. doi: 10.1002/term.2815.

(8) Uzun H, Bitik O, Uzun Ö, Ersoy US, Aktaş E. Platelet-rich plasma versus corticosteroid injections for carpal tunnel syndrome. J Plast Surg Hand Surg. 2017 Oct;51(5):301-305. doi: 10.1080/2000656X.2016.1260025.

(9) Sánchez M, Anitua E2, Delgado D, Sanchez P, Prado R, Orive G, Padilla S. Platelet-rich plasma, a source of autologous growth factors and biomimetic scaffold for peripheral nerve regeneration. Expert Opin Biol Ther. 2017 Feb;17(2):197-212. doi: 10.1080/14712598.2017.1259409.

(10) Berger DR, Centeno CJ, Kisiday JD, McIlwraith CW, Steinmetz NJ. Colony Forming Potential and Protein Composition of Commercial Umbilical Cord Allograft Products in Comparison With Autologous Orthobiologics. Am J Sports Med. 2021 Aug 16:3635465211031275. doi: 10.1177/03635465211031275. Epub ahead of print. PMID: 34398643.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

If you have questions or comments about this blog post, please email us at info@regenexx.com

NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

Posted on September 9, 2023 by Lynette Donnelly — Leave a comment

Mindfulness meditation use in chronic pain treatment in rural Australia: Pitfalls and potential – A case report

Meditation and mindfulness has been shown to not only help with mental health , but also the management of chronic pain.

The Federal Government funded mindfulness App Smiling Minds is a highly regarded free online tool, to help mental wellness and mindfulness techniques and programs

We believe our community can benefit from online programs facilitating self management tools.

Below is a research article exploring mindfulness meditation techniques.

2023 Jul-Sep; 14(3): 516–521.

Published online 2023 Aug 16. Prepublished online 2023 Feb 10. doi: 10.25259/JNRP-2022-4-7

PMCID: PMC10483197

Mindfulness meditation use in chronic pain treatment in rural Australia: Pitfalls and potential – A case report

Michael Eric Russell Bishop,¹ Mohammad Hamiduzzaman,² and Arron Sam Veltre²

Author information Article notes Copyright and License information PMC Disclaimer

Abstract

Mindfulness is a state of awareness characterized by open and non-judgmental recognition of thoughts and sensations and an ability to resist the usual wandering of an individual’s attention. Usually achieved by meditation, mindfulness is recognized as a treatment for chronic pain. Evidence, thus far, has been characterized by poor quality trials and mixed results, but a growing body of research is further investigating its effectiveness. Despite inconclusive evidence, the inherent difficulties of mindfulness research, and problems of accessibility in rural settings, mindfulness meditation is an emerging treatment strategy for many chronic pain patients. This report presents the case of a patient admitted to a rural hospital in New South Wales, whose quality of life was severely impacted by chronic pain.

Keywords: Aging, Behavioral neurology, Pain,

INTRODUCTION

Chronic pain is highly prevalent in rural Australia with a lack of holistic pain management services.^[1–3] Chronic pain is complex in its etiology and lasts longer than 3–6 months, or beyond the duration required for normal tissue healing after an acutely painful event.^[4] Acute pain is mostly biological in nature, whereas chronic pain results from a combination of biological, psychological, and social factors and often requires a multifactorial approach to evaluation and management.^[4,5] In Australia, one in every five people lives with persistent pain (i.e., 3.24 million Australians in total), and nearly 70% are of working age.^[6] However, referrals to pain specialists occur in <15% of GP consultations, whereas medications are used in nearly 70%.^[6] Access to holistic pain management services is especially poor in regional and rural Australia, with most multidisciplinary-care clinics located in major cities.^1,2 Allied health professionals, who are expected to play a significant role in the non-pharmacological treatment of chronic pain, are underrepresented in rural areas.^[7] Further, those who are able to access pain services often wait months to be seen, with a median wait time of 85 days in provincial (non-capital city) clinics.^[2] Given these challenges, chronic pain patients are often difficult to treat in rural and remote settings.

Mindfulness is a state of awareness characterized by open and non-judgmental recognition of thoughts and sensations and an ability to resist the usual wandering of an individual’s attention.^[8] Usually achieved by meditation, mindfulness is recognized as an effective treatment for chronic pain.^[9] Evidence, thus far, has been characterized by poor quality trials and mixed results, but a growing body of research is further investigating its effectiveness.^[9] Meditation uses a distinct brain pathway – change in the cortical thickness in the brain – to deal with chronic pain. Studies reported that mindfulness meditation promotes cognitive disengagement and also induces a person’s body opioid system to reduce the feeling of pain.^[8,9] Despite inconclusive evidence, the inherent difficulties of mindfulness research, and problems of accessibility in rural settings, mindfulness meditation is an emerging treatment strategy for many chronic pain patients.

This report presents a patient case admitted to a rural hospital in New South Wales, whose quality of life was severely impacted by chronic pain. As an adjunct to medication, mindfulness meditation became an important part of his treatment plan. This report highlights the effectiveness of mindfulness meditation and ends with a discussion of the difficulty accessing these services in rural Australia, and the role technology can play in improving access.

CASE REPORT

A Clinical Case in Rural Australia

Barry Davidson (pseudonym) was an inpatient at a rural hospital in New South Wales, Australia from July to September 2021. A 52-year-old T4 paraplegic, Barry had been admitted under the general surgeons for management of NPUAP stage 4^[10] pressure injuries from prolonged immobilization. The cause of these pressure injuries was Barry’s chronic abdominal and back pain, worsening dramatically over the previous few months to the point where any movement was painful. Living alone in rural New South Wales, it had become very difficult for Barry to continue managing his own care. While admitted, the surgical team investigated his abdominal and back pain. Blood tests and abdominal imaging found no pathology and a spinal MRI found old compression fractures of T4-5, now partially fused, but no acute pathology. He was further investigated for medical causes of his pain. Gastroscopy and colonoscopy were unremarkable, as were his kidney and liver function tests and full blood count. Ultimately, no cause of the chronic pain was identified. The network-wide chronic pain service was consulted, but they were only able to see Barry 3 weeks later, despite him remaining an inpatient. Due to the unfeasible waiting time for non-pharmacological services for chronic pain, he was commenced on oral paracetamol and 5–10 mg oxycodone by the Acute Pain Service, which worsened constipation and made him nauseous. He was then swapped to clonidine and rectal indomethacin. To encourage weaning of his dependence on opioids, he was also commenced on gabapentin and tapentadol. This regimen, however, led to a number of side effects including sedation and fatigue, so these were ceased in favor of duloxetine. Ultimately, he remained on regular oxycodone CR and PRN oxycodone and oxazepam. Barry was not fit to return to living alone; however, rural rehabilitation hospitals nearby thought that he was too complex to manage.

Barry was transferred to a smaller, rural rehabilitation hospital after 8 weeks as an inpatient, once his pressure injuries had healed. Despite this, the management of his chronic pain was still suboptimal. He recovered some function gradually with the help of nursing and allied health staff, while remaining on duloxetine, clonidine, indomethacin, oxycodone and oxazepam. Yet, his ongoing dependence on care prevented him from returning to his own home, and thus he was discharged to a residential aged care facility.

Management of Barry’s chronic pain

The management of Barry’s chronic pain within the inpatient setting and rural rehabilitation hospital was suboptimal. The chronic pain management in Australia is guided by the National Institute of Health and Care Excellence (NICE) guidelines.^[11] The first step is to treat any identifiable source of pain medically or surgically. Then, engage any of the non pharmacological therapies: Exercise, physical therapy, sleep hygiene techniques, behavioural and psychological therapies, healthy lifestyle interventions, or acupuncture. If there is an ongoing pain that interferes with normal functioning, pharmacological treatments may be added. For nociceptive pain, first line is NSAIDs; for neuropathic pain, there are a few options including antidepressants and antiepileptic drugs. If there is still insufficient response, opioids may be used, but only after consideration of severity of pain, and weighing the benefits and risks. A Cochrane review of opioids for long-term treatment of non-cancer pain found that continuation of long-term opioids led to clinically significant pain relief.^[12] However, the quality of the evidence in this review is weak; 25 out of 26 trials were case studies without controls, and the only randomized and controlled trial (RCT) compared two opioids. Evidence for other treatments, including physical activity^[13] and psychological therapy,^[14] is also weak, but these strategies are still advocated for.^[11]

The management of chronic pain in Barry’s case followed the above step-wedge approach, but limited access to non pharmacological services in the inpatient setting led to some divergence. The introduction of opioid analgesia came after excluding medical or surgical causes and high-dose oral paracetamol. Introducing the mindfulness meditation earlier may have reduced the need for opioid analgesia, but these strategies were difficult to implement in the busy inpatient environment and pharmacological options were preferred by Barry. While a resident in rural aged care facility, Barry began to engage in the meditation classes provided by a local meditation guide that visited the facility.

Effectiveness of mindfulness meditation in Barry’s case

Meditation became the most important part of his pain management in aged care facility. Barry attended weekly meditation sessions delivered to a group in an in-person setting. Over subsequent weeks, his participation steadily increased and his pain began to improve. Barry continued to attend the weekly meditation sessions over the following months and despite reporting that his pain was not completely resolved. In brief but noticeable moments of mindfulness, Barry has been able to focus on his pain, recognize it as an appearance in consciousness, and simply come to terms with it. On days that Barry meditates, he describes a lasting feeling that he is able to connect with feelings of pleasure and relief, even when at other times his pain is overwhelming. Barry was fortunate to have access to a meditation guide, as access to in-person meditation sessions is often rare in rural areas. Furthermore, Barry was unwilling to engage in online and app-based guided meditation, due to concerns of difficulty maintaining interest and enthusiasm. This may be a concern shared by many potential meditators and the regularity and commitment of an in-person program may improve engagement. However, a more flexible and individualized approach (such as through app-based courses) may still be preferable to many people.

DISCUSSION

The case that we have presented was initially an inpatient with chronic pain, who were referred to a rural residential aged care facility because of his ongoing dependency on care for pain. The strength of this case is the illustration of a step-wedge way of managing chronic pain in a monitored setting following the NICE guideline. However, the limitations were: (i) mindfulness meditation and low access to non pharmacological services, like mindfulness meditation in the inpatient setting; (ii) lack of individualized approach in therapy; and (iii) unwillingness to engage in online and app-based guided meditation. An understanding of and engagement with mediation as well as adequate access to such therapy in rural health-care settings would enhance the chance of managing chronic pain in a successful way.

In Western cultures, meditation is typically associated with yogis, hippies, and “self-help gurus,” has struggled to break from its Buddhist roots, and become established in an increasingly secular society. Dan Harris, an American news anchor, wrote a book about meditation after stumbling on the practice whilst working as a “religion correspondent.”^[15] This author asserts that the problem with meditation is that “its most prominent proponents talk as if they have a perpetual pan flute accompaniment,” but, “If you can get past the cultural baggage…you’ll find that meditation is simply an exercise for your brain.”^[15] Commonly, meditation sessions involve focused awareness on an appearance in consciousness, such as the sensation of breathing or the feeling of one’s body while sitting in a chair. Humans are constantly distracted by thought and meditation is the practice of recognizing these thoughts merely as appearances in our consciousness, just like sensations, and then re-orientating oneself to the practice. Each time one notices, they are lost in thought, the act of bringing attention back to the breath or sensations acts to train the mind. Mindfulness has been found to regulate the sensation of acute^[16] and chronic^[8] pain, improve cognition,^[17] and treat anxiety^[18] and depression.^[19]

Mindfulness-based stress reduction (MBSR) is a therapy developed by Jon Kabat-Zinn at the University of Massachusetts.^[20,21] It typically involves a standardized course of 8 weeks of mindfulness meditation sessions, performed once-weekly for 1.5–2.5 h [Figure 1].^[8,22–25] There has been important research in the last decade investigating the role of MBSR in the treatment of chronic pain,^[21,25–27] with inconsistent results. A number of studies show reduced pain intensity in groups treated with MBSR,^[24–26,28] but these improvements may be short lived.^[24] The mechanism by which pain is reduced in these patients has been postulated to be through the effects of medication on psychological factors. Indeed, a number of studies find that the benefits of meditation are most prominent in reducing symptoms of depression and anxiety and improving psychological functioning.^[23,27,29] One important trial, conducted on older patients in in whom pharmacological analgesia is often complicated by adverse effects, found that MBSR led to improvements in chronic pain.^[24] The MBSR approach is fairly common in the literature and has the largest evidence base supporting it; however, there is considerable heterogeneity in the format used depending on billing structure, type of session (guided vs. silent), and other factors. The approach taken by Barry involved ongoing weekly sessions 30 min in length, as facilitated by the meditation guide.

Figure 1:

Approach to the treatment of chronic pain, highlighting the role of mindfulness-based stress reduction.

Mindfulness is often associated with cognitive behavioral therapy (CBT), as there are many similarities between the two practices. Both are psychological therapies that encourage the practitioner to examine their thoughts, emotions, sensations, and behaviors. The techniques used in these practices, including deep breathing and self-reflection, are also common to both therapies. CBT has been studied since the 1980s but recent reviews suggest only a small to moderate effect on pain,^[14] with some patients receiving no benefit.^[30,31] Further, a number of studies have compared MBSR and CBT. A systematic review in 2011 found that MBSR was no better than CBT in the treatment of chronic pain, but it may be a good alternative.^[28] Despite the low quality evidence, the authors recommended therapies that combined both mindfulness and behavioral therapy. In a larger, randomized, and interviewer-blind trial, MBSR and CBT were both found to improve chronic low back pain compared to usual care, with no differences identified between MBSR and CBT.^[25] In one RCT of patients with rheumatoid arthritis (RA), CBT conferred the largest improvement in pain, but meditation was more beneficial in RA patients with psychological manifestations of their pain.^[32] The poor quality of many of the studies, however, makes it difficult to conclude the effectiveness of MBSR in treating chronic pain, as noted by a systematic review in 2012.^[22] A more recent RCT of 109 patients found no significant differences in pain measures between MBSR and a wait list control.^[23] Access to psychological therapies such as CBT is often difficult in rural areas. Improvements in technology, such as telehealth conferencing, may improve access to CBT, but the individualized therapy prohibits the scalability offered by online and app-based guided meditation services. Although technology may allow those in rural areas to access CBT services provided in metropolitan areas more easily, the format of one-on-one therapy may limit engagement due to wait times for appointments and out-of-pocket costs.

There are inherent difficulties in performing high quality trials of mindfulness in medical research. Measuring mindfulness is difficult and there is little consensus as to the components of the mindfulness experience.^[27] Much of the research involves self-reporting of results, which exposes trials to significant response bias.^[20] Further, problems emerge when designing control interventions, as many trials involve wait-list controls, where the control group is given no intervention for the study period, then offered the intervention at a later date.^[27] Another factor that compounds inconsistency of intervention is the modification of MBSR,^[27] leading to variability in the intervention given and reduced generalizability. There are also significant difficulties in elucidating the dose-response relationship of mindfulness,^[27] as measuring both the dose of meditation and the response to it is abstract and challenging. Some practitioners achieve benefit almost immediately and some require years of practice.

Further research should prioritize quality and comparison using quantitative measures, where possible. Structured measurements of mindfulness may be used, including scales such as the Mindfulness and Attention Awareness Scale^[33] and the Frieburg Mindfulness Inventory.^[34] A pain assessment in patients before and after the mindfulness session, using the appropriate scale such as Numerical Rating Pain Scale, Wong-Baker Faces Pain Scale, FLACC Scale, CRIES Scale, COMFORT Scale, or McGill Pain Scale would be a better scientific approach to such case study. These measures may allow for quantitative analysis of the effects of meditation and allow for correlation with pain scores. Empirical evidence of the extent of mindfulness may also reveal the most effective meditation techniques, including in specific subpopulations such as those with chronic pain. In addition, the future studies should incorporate active control groups and standardized mindfulness interventions,^[27] to promote comparison between different treatment modalities and to encourage adoption of mindfulness on a larger scale. High-quality RCTs using quantitative measurement of mindfulness and active control groups in chronic pain patients are needed.

There remains the problem of access to meditation services, especially in regional and rural areas. Access to guided meditation can be difficult and expensive. Classes and retreats are often fully booked with existing clients and those taking new clients are expensive. The Meditation Association of Australia suggests fees of up to $400/h for sessions delivered to community groups and $1000/h for businesses.^[35]

Practical steps in mindfulness meditation prescribing in rural areas

Technology has improved access to many health-care services for patients in rural areas. These services include pain management and research has suggested that delivery of meditation sessions through teleconferencing may be effective.^[36] Furthermore, access to mindfulness meditation services in rural areas has been transformed by the development of online and app-based resources. Many of these resources involve pre-recorded, guided meditation sessions, and delivered at a time of the practitioner’s convenience. In the era of COVID-19, when most group therapy sessions have been cancelled, these resources are especially relevant and may be preferable for many people. There are a variety of programs available online and to download. Some, such as Smiling Mind, Insight Timer, UCLA Mindful and Healthy Minds offer free access to meditation sessions. Some other apps, such as Headspace, Calm, Waking Up, and Stop Breathe Think, require a paid subscription, but often include extra content such as podcasts. Evidence for app-based delivery of mindfulness meditation in the treatment of chronic pain is lacking, but it represents a low cost, safe, and accessible option for patients in rural areas with less access to traditional services. Rural health practitioners may consider these emerging technologies when dealing with a multi-pronged approach to chronic pain.

The search for effective chronic pain treatments is ongoing, but there may be further benefit gained from existing strategies, such as mindfulness meditation and CBT. Our case clarifies the effectiveness of mindfulness, but lack of access to services was evident. It is a reasonable choice for clinicians to advocate for, due to its negligible harms, additional psychological benefits, and increasing accessibility through technology. Access to meditation services in rural and regional Australia may be challenging, but online and app-based programs may provide a new avenue for the treatment of chronic pain.

CONCLUSION

Funding Statement

Financial support and sponsorship

Nil.

Footnote

How to cite this article: Bishop ME, Hamiduzzaman M, Veltre AS. Mindfulness meditation use in chronic pain treatment in rural Australia: Pitfalls and potential – A case report. J Neurosci Rural Pract 2023;14:516-21

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent.

Conflicts of interest

There are no conflicts of interest.

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The Importance of Sleep for People With Chronic Pain: Current Insights and Evidence

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Pain And Sleep

2022 Jul; 6(7): e10658.

Published online 2022 Jun 17. doi: 10.1002/jbm4.10658

PMCID: PMC9289983

PMID: 35866153

Katie Whale^{1 ,}²and Rachael Gooberman‐Hill^{1 ,}²

Author information Article notes Copyright and License information PMC Disclaimer

ABSTRACT

We are currently in the midst of a sleep crisis. Our current work and lifestyle environments are normalizing poor sleep with substantial negative impact on our health. Research on sleep has linked sleep deprivation to poorer mental health, obesity, cancer, diabetes, heart disease, and a myriad of other health conditions. Sleep deprivation is an even greater issues for people with musculoskeletal conditions and chronic pain. Between 67% and 88% of individuals with chronic pain experience sleep disruption and insomnia, and at least 50% of people with insomnia report chronic pain. The link between sleep and pain is well documented. Experimental, cohort, and longitudinal studies have all demonstrated that restricted sleep is linked to greater pain. Poor sleep therefore not only affects general health but has a direct impact on inflammation, pain response, and experience. Improving sleep in people living with musculoskeletal conditions and with chronic pain has the potential to deliver great benefit to many. This article describes the evidence base that can underpin such work, including research about the link between pain and sleep as well as theories and approaches to intervention that may help.

Keywords: PRACTICE/POLICY‐RELATED ISSUES, DISEASES AND DISORDERS OF/RELATED TO BONE, EPIDEMIOLOGY, ORTHOPAEDICS

Introduction

Good quality sleep is essential to health and wellbeing across the whole life course. Sleep deprivation is associated with mental health difficulties,⁽ ¹⁾ obesity,⁽ ²^,³⁾ cancer,⁽ ⁴^,⁵⁾ type 2 diabetes,⁽ ⁶⁾ heart disease,⁽ ⁷⁾ and many other health conditions. Conversely, good quality sleep supports physical recovery, memory consolidation, learning, and positive mood.⁽ ⁸⁾ Poor sleep is common among people living with painful musculoskeletal conditions and can have a serious negative impact on their lives and pain management. Addressing sleep and providing ways to support and improve sleep can provide benefit to many. We suggest that there is a clear need to develop, evaluate, and implement care for sleep among people living with musculoskeletal pain. This article describes the evidence base that can underpin such work, including research about the link between pain and sleep as well as theories and approaches to intervention that may help.

Prevalence of Sleep Issues and Chronic Pain

Sleep deprivation and interrupted sleep are substantial issues for people who experience chronic pain (pain lasting longer than 3 months). A recent systematic review on the prevalence of sleep disturbance for those with non‐cancer pain indicates that between 72% and 75% of this population experience sleep disturbance,⁽ ⁹⁾ with other research putting the figure at 88%.⁽ ¹⁰^,¹¹⁾ Musculoskeletal conditions are frequently associated with sleep issues with prevalence of up to 65% in rheumatoid arthritis, 70% in osteoarthritis, and 95% in fibromyalgia.⁽ ⁹⁾ Individuals who experience both chronic pain and sleep problems are likely to have greater pain severity, longer duration of pain, greater disability, and be less physically active than those without sleep disturbance.⁽ ¹²⁾ In addition, people who have both pain and sleep difficulties are more likely to experience depression, catastrophizing, anxiety, and suicide ideation.⁽ ¹²⁾

Link Between Sleep and Pain

There is a robust evidence base for the link between sleep and pain. Experimental, cohort, and longitudinal studies have all demonstrated that restricted sleep is linked to greater pain. Experimental studies have examined the short‐term impact of sleep restriction on pain, commonly using pain threshold tests such as cold pressure. These studies have consistently shown that sleep deprivation in healthy subjects, in particular slow wave sleep restriction (deep restorative sleep), is associated with increased pain stimulus responses.⁽ ¹⁰^,¹³⁾ However, these approaches have limited generalizability for people with chronic pain because they do not mirror their experience. People living with chronic pain commonly experience waking several times each night as well as long‐term reduced sleep quality. Some studies have sought to address this by using “forced awakening” techniques, which forcibly awaken participants multiple times per night. Smith and colleagues⁽ ¹⁴⁾ conducted a study in which otherwise healthy women were awakened at eight intervals during the night over an 8‐hour sleep period. This restricted their total sleep time to 280 minutes (just over 4.5 hours). Compared with a group who had restricted sleep (same total sleep time but uninterrupted) and a control group who slept for 8 hours, forced awakening was associated with greater next‐day spontaneous pain reports and reduced conditioned pain modulation (reduction in the body’s ability to process pain resulting in greater pain experiences).

Prospective longitudinal studies focusing on the effect of sleep on future pain have reported similar findings. Studies in people who experience headaches and migraines have shown that elevated insomnia symptoms increase the risk of exacerbating existing headache, and in developing new headache symptoms at long‐term follow‐up ranging from 1 to 12 years.⁽ ¹⁵^,¹⁶⁾ Sleep quality has also been examined in relation to postsurgical pain: preoperative sleep quality affects postoperative pain,⁽ ¹⁷^,¹⁸^,¹⁹⁾ including joint arthroplasty.⁽ ²⁰⁾ This is of particular interest in chronic pain research as joint replacements are predominantly carried out to relieve the symptoms of chronic pain for conditions such as osteoarthritis.

Temporal Relationship Between Sleep and Pain

A subject of recent research has been the temporal relationship between sleep and pain and the day‐to‐day predictive associations. The bi-directionality of the relationship is widely accepted,⁽ ¹⁰^,²¹⁾ with poor sleep leading to worse pain and pain negatively impacting sleep; however, the strength and direction of the association is less clear. There is growing body of evidence that suggests a temporal precedence for sleep over pain, such that sleep impairment is a stronger predictor of pain than pain is a predictor of sleep impairment.⁽ ¹²^,¹³⁾ A study including adolescents with a range of chronic pain conditions found that total sleep time and wake after sleep onset (waking during the night) were associated with next‐day pain reports; however, pain levels did not predict sleep quality or efficiency.⁽ ²²⁾

Sleep problems have been identified as a risk factor for development of musculoskeletal pain. A Swedish prospective population study identified that problems with initiating sleep, maintaining sleep, early awakening, and nonrestorative sleep predicted the onset on chronic widespread pain over 5 and 18 years in individuals with no pain at baseline, irrespective of mental health status. In addition, sleep problems and fatigue independently predicted chronic widespread pain at 5 years.⁽ ²³⁾ Research has suggested the underlying mechanism for this association is increased systemic inflammation.⁽ ²⁴⁾ New research examining this relationship has found that this association is mediated by high or low affect (mood/emotional state).⁽ ²⁵⁾ Low positive affect and sleep disturbance were associated with increased inflammation levels, and high positive affect identified as a protective factor.

Relevance for Research and Treatment of Chronic Pain

Musculoskeletal chronic pain conditions come with different pain profiles, and sleep experience may vary according to condition. Understanding the nature of the relationship between sleep and pain in a variety of conditions may provide key information for design of treatment approaches.

As well as defining pain by reference to condition or diagnosis, considering pain type without reference to associated condition provides key information that may be relevant to sleep. Nociceptive and inflammatory pain is associated with damage to tissue, such as osteoarthritic joint damage.⁽ ²⁶⁾ Nociceptive pain (pain caused by damage to body tissue) is commonly treated with traditional analgesics and anti‐inflammatory medication.⁽ ²⁷⁾ Neuropathic pain is associated with changes to the nerves themselves and affects the way pain signals are sent back to the brain.⁽ ²⁸⁾ Medicines that may provide benefit for people with nociceptive pain may do little to alleviate neuropathic pain symptoms. Of the 20% of the population who live with chronic pain in the UK, approximately 8%–9% experience chronic neuropathic pain,⁽ ²⁹⁾ highlighting a large population who may not benefit from conventional pharmacological pain management.

In 2017, a new category of pain experience was introduced by the International Association for the Study of Pain (IASP): “nociplastic” pain.⁽ ³⁰⁾ Nociplastic pain is defined as “pain arising from the altered function of pain‐related sensory pathways in the periphery or central nervous system, causing increased sensitivity.”⁽ ³¹⁾ This type of pain can occur in isolation or alongside chronic pain conditions that are primarily nociceptive or neuropathic. Nociplastic pain in common in fibromyalgia and is thought in part to be due to changes in how pain is processed by the nervous system, such as in central sensitization (increased pain response/pain hypersensitivity to external stimuli).⁽ ³²⁾

Non-pharmacological treatment approaches focused on pain management are the first line recommendation for nociplastic pain, and these include sleep hygiene (healthy sleep habits). Along with patients who experience neuropathic pain, sleep interventions may offer a positive treatment approach for nociplastic pain.

Intervention Approaches

Interventions to improve sleep for people with pain include pharmacological and a range of other approaches. Although pharmacotherapy treatments may offer short‐term solutions to problems such as sleep latency (taking a long time to fall asleep), they may have unwelcome side effects and are not recommended for long‐term use.⁽ ³³⁾ Behavioral and psychological interventions have gained traction in recent years as ways to improve sleep without side effects and to provide long‐term support.

Our recent systematic review of non-pharmacological sleep interventions for chronic pain identified a large range of existing sleep interventions including relaxation, mindfulness, physical therapies, and exercise.⁽ ³⁴⁾ Cognitive behavioral therapy (CBT) approaches provided the largest evidence base, and these included CBT for insomnia (CBT‐i), CBT for pain (CBT‐P), and combined approaches (CBT‐iP). CBT‐i can be delivered on an individual or group basis and consists of a course of sessions focusing on psychoeducation and sleep hygiene information, sleep restriction, relaxation, stimulus control, and cognitive therapy.

Evidence about the effectiveness of CBT for improving sleep indicates that CBT can provide equal benefit or be superior to pharmacotherapy.⁽ ³⁵⁾ Systematic reviews of CBT interventions demonstrate significant improvements in sleep quality in the short and medium term for CBT‐i⁽ ³⁴⁾ and for global measures of sleep.⁽ ³⁶⁾ Condition specific reviews including patients with lower back pain, fibromyalgia, and osteoarthritis show similar results with CBT therapies improving short‐term sleep outcomes.⁽ ³⁶^,³⁷^,³⁸^,³⁹⁾

CBT may be particularly suitable for people with chronic pain because such approaches can address pain and sleep in tandem. Some individuals who live with chronic pain may engage in “pain catastrophizing.” Individuals who experience pain catastrophizing experience greater pain related fear (fear of physical movement and activity resulting in pain), this can lead to pain avoidant behaviors and pain hypervigilance.⁽ ⁴⁰⁾ Engaging in the fear‐avoidance cycle of pain means it can be very difficult for these individuals to focus on anything other than their pain or break this cycle 66–67. Pain catastrophizing has an additional negative impact on pain related sleep issues as pain rumination contributes to sleep disturbance.⁽ ⁴¹^,⁴²⁾ CBT‐P and CBT‐iP have been shown to improve pain coping, reduce catastrophizing, and increase pain acceptance.⁽ ⁴³⁾

Until recently, behavioral and psychological therapies were usually delivered in person either on a one‐to‐one or group basis. Increasingly, therapies are delivered remotely using video appointments, websites, or digital apps. Websites and apps may deliver automated CBT, and studies that have evaluated such approaches have found them to be an effective and acceptable means of delivery.⁽ ⁴⁴^,⁴⁵⁾ With growth in the online wellness industry, the range of smartphone apps providing digital access to relaxation and mindfulness methods has increased substantially in recent years. Unlike the evidence base for automated CBT, evidence relating to relaxation and mindfulness is less developed; however, a studies of a commercial relaxation app found that most users reported improved sleep, including falling asleep and staying asleep, and overall sleep quality.⁽ ⁴⁶^,⁴⁷⁾ However, findings were limited to a sample who were primarily female and who had high levels of education. Socio-economic factors are an important consideration when designing and assessing the impact of digital sleep interventions; although digitally enabled interventions may provide an accessible route for many, those without digital access may be excluded. Availability of devices, digital literacy, internet access in rural and urban areas, and the range of language availability need to be considered.⁽ ⁴⁸⁾

Support for Change: The Role of Behavior Change Theories

Individuals’ beliefs about their health conditions or experiences can have considerable impact on engagement in interventions—such as CBT—that require behavior change. From health psychology, the common sense model of health representation, first proposed by Leventhal, Meyer, and Nerenz, focuses on the relationship between illness‐representation (individual beliefs and expectations about an illness), coping, and health outcomes.⁽ ⁴⁹⁾ This model suggests that perceived causes of a condition and the curability or controllability form part of an individual’s illness perception. This perception then impacts how someone responds to treatment recommendation. Although musculoskeletal conditions may be associated with different types of sleep difficulties, it is also likely that perceived causes of a condition, curability, and controllability weigh heavily in beliefs about sleep. Furthermore, in current society, although sleep is increasingly the subject of wellness intervention, poor sleep (particularly short duration of sleep) is frequently normalized or accepted as part of life.⁽ ⁵⁰⁾ People who live with painful musculoskeletal conditions may see poor sleep as an inevitable consequence of living with pain⁽ ⁵¹⁾ and as out of their personal control.⁽ ⁵²⁾ Addressing these deeply held views about sleep and condition may be an important element of methods to improve sleep.

Individuals with chronic pain may experience disturbed sleep for many months or years, which means that engagement with sleep interventions need to be long‐term. Despite an absence of evaluations of the longer‐term effectiveness of sleep interventions for people with chronic pain, health psychology offers guidance about how behavior change can be sustained. For instance, theories of motivation—such as self‐determination theory⁽ ⁵³^,⁵⁴⁾—posit that intrinsic motivation is key to long‐term change. Intrinsic motivation is internal personal motivation, which can be developed and supported through support for individuals’ feelings of autonomy, competence, and relatedness. In other words, people are more likely to be motivated to change if they believe that they are in control of the change, feel able to achieve the change, and sense that they are supported by and connected to other people. Beliefs about sleep and pain may undermine feelings of autonomy and self‐efficacy. Reductions in these feelings may impact on motivation that would bolster and facilitate engagement in active treatments or behavioral change. Bringing focus on health beliefs and motivation together highlight the importance of education about sleep and pain alongside or within interventions that promote autonomous motivation and competence.

Conclusions

Promoting good quality sleep is important for people with pain related to musculoskeletal conditions. A range of sleep problems can be addressed through existing interventional approaches that are underpinned by established theories. Identifying which approach to use when and with whom depends on a full understanding of individual health beliefs that relate to sleep as well as identification of barriers to behavior change. Progress in our understanding of the complex relationship between sleep and pain provides a promising basis for interventions that may improve sleep, help with pain, and augment health‐related quality of life. Future research to develop and evaluate tailored sleep interventions should identify whether support for sleep should be embedded into self‐management and healthcare provision.

Author Contributions

Katie Whale: Conceptualization; formal analysis; writing – original draft; writing – review and editing. Rachael Gooberman‐Hill: Conceptualization; writing – review and editing.

Peer Review

The peer review history for this article is available at https://publons.com/publon/10.1002/jbm4.10658.

Acknowledgments

This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care.

Authors’ roles: KW was responsible for the conception of this review, review and analysis of existing literature, manuscript preparation, and approval of the final submitted version. RGH was responsible for the conception of this review, manuscript preparation, and approval of the final submitted version.

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Articles from JBMR Plus are provided here courtesy of Wiley-Blackwell

Posted on August 12, 2023 by Lynette Donnelly — Leave a comment

Transcranial Magnetic Stimulation for Chronic Neuropathic Pain

Transcranial Magnetic Stimulation for Chronic Neuropathic Pain a research trial conducted by the University of California and San Francisco (UCFS)

a study on

for people ages 18-80 (full criteria)

at San Francisco, California

study started April 2022 estimated completion January 2025

by Julian C Motzkin, MD/PhDPrasad Shirvalkar, MD/PHD

Description

SUMMARY

Chronic neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. It is highly prevalent, debilitating, and challenging to treat. Current available treatments have low efficacy, high side effect burden, and are prone to misuse and dependence. Emerging evidence suggests that the transition from acute to chronic neuropathic pain is associated with reorganization of central brain circuits involved in pain processing. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment that uses focused magnetic pulses to non-invasively modulate brain activity, a strategy that can potentially circumvent the adverse effects of available treatments for pain. RTMS is FDA-approved for the treatment of major depressive disorder, obsessive-compulsive disorder, and migraine, and has been shown to reduce pain scores when applied to the contralateral motor cortex (M1). However, available studies of rTMS for chronic neuropathic pain typically show variable and often short-lived benefits, and many aspects of optimal treatment remain unknown, including ideal rTMS stimulation parameters, duration of treatment, and relationship to the underlying pain etiology. Here the investigators propose to evaluate the efficacy of high frequency rTMS to M1, the region with most evidence of benefit in chronic neuropathic pain, and to use functional magnetic resonance imaging (fMRI) to identify alternative rTMS targets for participants that do not respond to stimulation at M1. The central aim is to evaluate the pain relieving efficacy of multi-session high-frequency M1 TMS for pain. In secondary exploratory analyses, the investigator propose to investigate patient characteristic that are predictive of responsive to M1 rTMS and identify viable alternative stimulation targets in non-responders to M1 rTMS.

OFFICIAL TITLE

A Pilot Trial of Longitudinal Repetitive Transcranial Magnetic Stimulation (rTMS) for Chronic Neuropathic Pain

DETAILS

The investigators will recruit 20 patients diagnosed with chronic neuropathic pain for a randomized, single-blind, 2-arm crossover pilot TMS treatment trial. Participants will be recruited outpatients from departments of neurosurgery, neurology, and pain medicine at UCSF; patients referred from other hospitals or clinics as candidates of this trial. Baseline screening, clinical interviews, behavioral testing, and recording of pain scores will be performed in either the UCSF Nancy Friend Pritzker Psychiatry Building, UCSF Pain Management Center, or UCSF Mount Zion Hospital prior to the first treatment session. Eligible patients will be randomized to one of two stimulation frequencies: high frequency (10Hz) excitatory vs low frequency (1Hz) inhibitory repetitive transcranial magnetic stimulation (rTMS). We will use clinical and research TMS devices that have been cleared by the FDA for treating obsessive compulsive disorder and refractory major depressive disorder (located in the Pritzker Building) through a collaboration with Dr. Andrew Krystal (Director of UCSF Interventional Psychiatry Program and Co-Director of the TMS & Neuromodulation Clinic) and Dr. Moses Lee (Director of OCD clinic) at UCSF.

Randomized patients will return for once daily rTMS sessions for 10 consecutive weekdays. On the first randomization visit, participants will record their current pain level using a visual analog scale (VAS), complete a variety of self-report scales (e.g., NIH PROMIS questionnaires, pain map, McGill Pain Questionnaire (MPQ), Pain Catastrophizing Scale (PCS), Pain Anxiety Symptom Scale (PASS), Beck Depression Inventory-II (BDI-II), WHO Disability Assessment Schedule (WHODAS), Patient Global Impression of Change (PGIC), and Pittsburgh Sleep Quality Index (PSQI)), and undergo a brain MRI session consisting of T1-weighted, T2-weighted, and diffusion tensor anatomical scans as well as functional MRI (fMRI) scans at rest and while rating spontaneous pain. Using single-pulse TMS, the investigators will estimate individual resting motor thresholds (RMT) of the affected extremity. Each treatment visit will consist of either: a series of thirty 10-Hz stimulations to the target brain regions at 90% RMT (each lasting 10 s with 50 s between stimulations, for a total of 3,000 pulses per visit) or thirty 1-Hz stimulations to the target brain regions at 90% RMT (total of 300 pulses per visit). Each treatment session will last ~30 min. Electromyography (EMG), heart rate and galvanic skin conductance will be recorded continuously throughout each session.

After completing the first 10 sessions, participants will have the option to receive additional stimulation with at either the same region or at a new target region, determined by each subject’s baseline MRI scan, at the same frequency with the same schedule as the first session of treatment. Non-responders (<35% improvement of VAS scores) and those with relapse post-treatment to within 35% pre-treatment baseline pain severity will cross over to the new target arm. Participants will be followed for 6-months to evaluate the duration of benefit with follow up assessments at 1 week, 1 month, and 6 months.

KEYWORDS

Chronic Neuropathic Pain, Post-Stroke Pain, Trigeminal Neuralgia, Nerve Injury, Spinal Cord Injuries, Pain, Postoperative, Complex Regional Pain Syndromes, Post-herpetic Neuralgia, Nerve Root Avulsion, Pain, Neuropathic Pain, TMS, Neuromodulation, Neuralgia, Reflex Sympathetic Dystrophy, Postherpetic Neuralgia, Radiculopathy, Postoperative Pain, Wounds and Injuries, High Frequency rTMS, Low Frequency rTMS

Eligibility YOU CAN JOIN IF…

Open to people ages 18-80

Meets Criteria for Chronic Neuropathic Pain (NP):
1. “Pain caused by a lesion or disease of the somatosensory nervous system
2. Intractable pain longer than 6 months after pain onset
3. Baseline VAS score 30-94-mm
4. Currently prescribed pain medication for NP, history of prior medication trials without adequate pain control, or refused treatments for individual reasons
5. Continuous pain in face and/or extremities
Age 18-80
Any gender and all ethnoracial categories
Stable on chronic pain medications for 4 weeks prior to the study and agreeable to continue throughout the study. These medications include: Tricyclic antidepressants (e.g., nortriptyline, amitriptyline), SNRIs (e.g., duloxetine, venlafaxine), gabapentinoids (e.g., gabapentin, pregabalin), antiepileptics (e.g., valproic acid, carbamazepine, lamotrigine), and daily anti-inflammatories (e.g., meloxicam), among others (as determined by study physician at the time of screening). Note: Medications that are known to increase cortical excitability (e.g., buproprion, maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an inhibitory effect on brain excitability (e.g., antiepileptics, benzodiazepines, and atypical antipsychotics), or any other medications with relative hazard for use in TMS will be allowed upon review of medications and/or motor threshold determination by TMS specialist.
Participants may continue to take as-needed pain medications and record daily usage throughout the experiment
Capacity to provide informed consent
Ability to tolerate study procedures
Successfully complete the screening forms without contraindications

YOU CAN’T JOIN IF…

Neurologic: Dementia, Severe neurocognitive disorder (MoCA < 22), Severe aphasia, Seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis), or complete paralysis at target site
Psychiatric: DSM Axis I disorder, Suicidal thoughts, prior psychosurgery, prior ECT
Procedural: prior rTMS within 1 year of consent, enrollment in other clinical trial in the past 6 months
TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk
Participants with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, cardiac disease)
Females who are pregnant or nursing
Inability to complete the research study

Location

UCSF Medical Center accepting new patients
San FranciscoCalifornia94158United States

Lead Scientists

Julian C Motzkin, MD/PhD
Fellow, Neurology, School of Medicine. Authored (or co-authored) 16 research publications
Prasad Shirvalkar, MD/PHD
Associate Professor, Anesthesia, School of Medicine. Authored (or co-authored) 33 research publications. Research interests: Pain Management · Neuromodulation · Deep Brain Stimulation · Headache · Neuropathic Pain · Spinal Cord Stimulation · Post Stroke Pain · Phantom Limb Pain

Details

Status: accepting new patients
Start Date: April 2022
Completion Date: January 2025 (estimated)
Sponsor: University of California, San Francisco
ID: NCT05593237
Study Type: Interventional
Participants: Expecting 20 study participants
Last Updated: July 12, 2023

I’m interested in this study!

Posted on August 2, 2023 by Lynette Donnelly — Leave a comment

The Lady With “Electrical” Facial Pain – Steven Graff-Radford, DDS

Sometimes people living with trigeminal neuralgia fear that they are invisible, that nobody in the medical field is interested in the disorder and that there is no hope.

However there are many inspiring medical professionals who have dedicated their lives to researching and treating facial pain disorders.

One such professional was Steven Graff-Radford DDS who sadly passed away at the age off 59 in 2016

Dr. Graff-Radford came to UCLA in 1978 as a young dental school graduate from South Africa. He had been accepted to UCLA’s Oral Surgery Residency program and was exploring educational opportunities in the dental school prior to beginning his program.

He began studying temporomandibular disorders (TMD) and was interested in the way chronic pain was being treated at the UCLA Department of Anesthesia Pain Management Center. In 1982, Dr. Graff-Radford was offered a fellowship in pain management, which became his life’s focus. After completing the program, he began teaching and treating patients at the center and eventually became the education director.

In 1990, he approached the dental school administrators with a proposal to create an orofacial pain residency program. The program became the first residency program in orofacial pain in the world and became a model for similar programs. His program was so impactful that it became the example that the American Board of Orofacial Pain adopted for their board exam.

He published 150 research papers involving facial pain and dentistry and provided pain relief for many of his patients.

One article can be accessed below and the questions he poses throughout the article are pertinent for medical professionals and patients. So often we have to educate ourselves.

The Lady With “Electrical” Facial Pain - Steven Graff-Radford, DDS

The FPA also posted a tribute to Dr Graff-Radford in their journal on pages 5-6

FPA Winter Journal 2017

Posted on August 2, 2023August 2, 2023 by Lynette Donnelly — Leave a comment

Podcast – E207 Remote Patient Monitoring with Dr. Krishnan Chakravarthy

The world of artificial intelligence (AI) is likely to enable huge efficiency with remote patient monitoring and interfacing with medical practitioners and research models.

This podcast is based on the American Market but with opportunity to expand to India and Australia and describes the work now being done to create an affordable pain management product which provides remote patient diagnostic, therapy and data collection remotely.

Note – the subject matter is complex but really describes well the future options for remote interactive care for chronic pain patients.

Dr. Krishnan Chakravarthy is an expert anesthesiologist with a unique specialization in multi-modal pain management. In this episode, he delves into the fascinating world of pain management start-ups and med-tech. Dr. Chakravarthy emphasizes the significance of understanding the key problems in the industry when developing core technologies for the market. He sheds light on his team’s mission to make cutting-edge technology more accessible and affordable, aiming to reach a broader population in need of specialized care.

About Krishnan Chakravarthy, MD, PhD
Krishnan Chakravarthy, MD, PhD, is an anesthesiologist who specializes in multi-modal pain management. As a pain management specialist, he evaluates, diagnoses and treats all forms of pain. Dr. Chakravarthy performs a variety of procedures to treat chronic pain, specializing in dorsal root stimulation therapy, a type of neurostimulation therapy designed to manage pain in areas of the lower body such as the foot, knee, hip or groin; dorsal column stimulation; and peripheral nerve stimulation.

As an assistant professor in the Department of Anesthesiology, Dr. Chakravarthy instructs medical students, residents and fellows at UC San Diego School of Medicine. His research interests include incorporating new technology into advancing pain care. This includes advancing the field of neuromodulation as well as using nanotechnology to develop new drug delivery and point of care device platforms to manage chronic pain.

His research work has been featured in national and international venues and has been published in top journals, including Anesthesiology, Proceedings of the National Academy of Sciences of the United States of America, and Pain.

Dr. Chakravarthy currently serves on the editorial board of several national and international peer reviewed journals, and committees on organizations such as the International Neuromodulation Society.

He completed fellowship training in pain management at Harvard Medical School, Massachusetts General Hospital and residency training in anesthesiology at Johns Hopkins School of Medicine, The Johns Hopkins Hospital. Dr. Chakravarthy earned his medical and doctorate degree from the University at Buffalo School of Medicine and Biomedical Sciences.

An entrepreneur, Dr. Chakravarthy is a founder of several biotechnology startup companies focusing on nanotechnology small molecule development in the chronic pain space.

Outside of work, Dr. Chakravarthy enjoys squash. He speaks Tamil and is conversant in French.

Posted on August 1, 2023August 1, 2023 by Lynette Donnelly — Leave a comment

High concentration topical capsaicin for chronic neuropathic pain

We are constantly looking for treatments which may have an application to relieve neuropathic pain.

In 2002 an Australian Doctor Hugh Spencer published his story about utilising capsaicin to cure his own trigeminal neuralgia. His process required making a mouth guard from an imprint of the patient’s teeth, adding a cloth brushed with capsaicin and rubbing alcohol, and adding to the outside of the guard to have contact to the gums. The process took time and effort and the treatment not very pleasant in the short term, however his pain receded and eventually disappeared.

In the following years there has been research completed on the benefits of capsaicin.

Capsaicin – Chemical compound
Capsaicin is an active component of chili peppers, which are plants belonging to the genus Capsicum. It is a chemical irritant and neurotoxin for mammals, including humans, and produces a sensation of burning in any tissue with which it comes into contact. Wikipedia

Formula: C18H27NO3
Scoville scale: 16,000,000 SHU
Heat: Above peak; (pure Capsaicin is toxic)

High concentration topical capsaicin for chronic neuropathic pain

Published by Dr Hanan Khalil May 2017

369 participants included patients with peripheral diabetic neuropathy reported. The study reported that 10% more participants had at least a 30% reduction with high-concentration capsaicin than with placebo at 8 and 12 weeks of treatment.

Four studies included 1,272 participants with post-herpetic pain and found improvement of pain intensity reduction of 30% or greater in favour of the intervention compared to the control group.

Adverse events were common but not significantly different between the control and intervention groups. Withdrawal rates did not differ between the two groups. The treatment was not associated with death. The included studies that reported on pain reduction in favour of the intervention also reported on improvement of sleep, fatigue, depression and quality of life of the participants.

Conclusion

The small number of trials included in this summary found that high concentration of capsaicin was effective in reducing neuropathic pain associated with diabetes, HIV and post-herpetic neuralgia. There was also additional improvement of sleep, fatigue, depression and quality of life amongst the participants using the high concentration of capsaicin.

Implication for practice

High concentration topical capsaicin can be used to relieve neuropathic pain. Further studies on the effects of its long-term use in patients with chronic neuropathic pain are warranted.

DR HANAN KHALIL is the Director of the Centre for Chronic Disease Management, a collaborating centre of the Joanna Briggs Institute, Faculty of Medicine, Nursing and Health Sciences, Monash University, and a reviewer for the consumer group of the Cochrane Collaboration. She is also Editor in Chief of the International Journal of Evidenced Based HealthCare.

The purpose of this evidence summary is to provide the best available evidence for the effectiveness of vitamin E for managing mild cognitive impairment and Alzheimer’s dementia.

For the Full Cochrane review, please refer to: Farina N, Llewellyn D, Isaac MG, Tabet N. Vitamin E for Alzheimer’s dementia and mild cognitive impairment. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD002854. DOI: 10.1002/14651858.CD002854. pub4.¹

References

Derry S, Rice ASC, Cole P, Tan T, Moore RA. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD007393. DOI: 10.1002/14651858.CD007393.pub4
van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain 2014;155(4): 654–62. [DOI: 10.1016/j.pain.2013.11.013]
Pergolizzi J, Ahlbeck K, Aldington D, Alon E, Coluzzi F, Dahan A, Huygen F, Kocot-Kępska M, Mangas AC, Mavrocordatos P, Morlion B. The development of chronic pain: physiological CHANGE necessitates a multidisciplinary approach to treatment. Current medical research and opinion. 2013 Sep 1;29(9):1127–35.
Khalil H. Painful diabetic neuropathy management. International Journal of Evidence-Based Healthcare. 2013 Mar 1;11(1):77–9.
Anand P, Bley K. Topical capsaicin for pain management: therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch. British Journal of Anaesthetics 2011;107(4):490–502. [DOI: 10.1093/bja/ aer260]

Other Research

Capsaicin: Current Understanding of Its Mechanisms and Therapy of Pain and Other Pre-Clinical and Clinical Uses

Capsaicin 8% Dermal Patch: A Review in Peripheral Neuropathic Pain

The association does not recommend a particular treatment for trigeminal neuralgia. Please always consult your medical practitioner to discuss products and options appropriate for your specific care.

Posted on July 10, 2023July 15, 2023 by Lynette Donnelly — Leave a comment

Vitamin D supplementation reduces risk of major cardiovascular events in older adults

This study evaluates whether Vitamin D supplementation reduces risk of major cardiovascular events in older adults. Vitamin D has also been linked in studies to reduce inflammation and is so important to help live life well.

Why would this be important for people who live with trigeminal neuralgia?

Statics show that trigeminal neuralgia affects older females. Females are often not aware of their risk factor around heart health and are more likely to be diagnosed with TN.

More than half a million women have cardiovascular disease

In 2017–18, an estimated 510,000 (4.8%) Australian women aged 18 and over had 1 or more heart, stroke and vascular diseases, based on self-reported data. About 206,000 women had coronary heart disease, and 37,000 had heart failure.

Cardiovascular disease in Australian women— a snapshot of national statistics

Cardiovascular disease (CVD) is the leading cause of death worldwide, yet important differences exist between men and women. Men generally develop CVD at a younger age and have a higher risk of coronary heart disease (CHD) than women. Women, in contrast, are at a higher risk of stroke, which often occurs at older age.

The incidence of TN was estimated to be 5.5 (95% confidence interval 4.7–6.4) per 100,000 person-years. The incidence increased with age, from 0.1 in 0- to 19-year-olds to 23.1 per 100,000 person-years in 80+-year-olds. Females exhibited a higher incidence at 7.3 than males at 3.7 per 100,000 person-years.20 Jan 2023

Background
Within the vascular system, most of the cells that express the vitamin D receptor also express 1α-hydroxylase and can convert 25-hydroxyvitamin D (25(OH)D) to calcitriol, the active form of vitamin D. Calcitriol has several
important biological functions including inflammation reduction, inhibition of
proliferation of vascular smooth muscle, and regulation of the renin-angiotensin-aldosterone system.
One meta-analysis of RCTs indicated that vitamin D supplementation was
ineffective in preventing cardiovascular events. However, this outcome was
contradicted by the Women’s Health Initiative Trial, which included women participants and a low dose of Vitamin D.
The D-Health Trial was launched to evaluate whether monthly vitamin D supplementation improves the health outcomes of older adults. Although a previous analysis using the D-Health cohort reported that vitamin D supplementation did not reduce mortality due to cardiovascular disease or all-cause mortality, their effect on the incidence of major cardiovascular events was not determined.

Read the full findings in the below research paper

Vitamin D supplementation reduces risk of major cardiovascular events in older adults

Further research Vitamin D and Inflammation

Vitamin D deficiency and C-reactive protein: a bidirectional Mendelian randomization study

A study from Ireland

Vitamin D status & associations with inflammation in older adults

Posted on April 21, 2023April 27, 2023 by Helen Tyzack — Leave a comment

Safety of microvascular decompression for elderly patients with trigeminal neuralgia

Research article: Safety of microvascular decompression for elderly patients with trigeminal neuralgia

The following is an excerpt of a longer article which can be read in the journal, Clinical Neurology and Neurosurgery, Volume 141, February 2016, Pages 77-8. Authors: Kenichi Amagasaki, Saiko Watanabe, Kazuaki Naemura, Naoyuki Shono, and Hiroshi Nakaguchi. More detail can be located online at: https://www.sciencedirect.com/science/article/abs/pii/S0303846715301062

Objective

The study compared the safety and efficacy of microvascular decompression (MVD) in groups of elderly patients and non-elderly patients with medically refractory trigeminal neuralgia (TN) and collected detailed perioperative data.

Methods

Retrospective analysis of clinical data was performed in 99 patients who underwent MVD from May 2012 to June 2015. The outcome data from 27 MVD operations for 27 patients aged 70–80 years (mean 74.6 years) were compared with 72 MVD operations with 72 patients aged 25–69 years (mean 55.7 years). Preoperative comorbidities were recorded and postoperative worsening comorbidities and non-neurological complications were evaluated at discharge. Efficacy of the surgery and neurological complications were evaluated in July 2015.

Introduction

MVD is often described as the most effective treatment to achieve initial and long-term pain control for TN. However, percutaneous procedures have also showed good results, and both percutaneous procedures and MVD provide acceptable outcomes. TN occurs more frequently with higher age, but older patients are thought to have higher risks for surgery and anaesthesia compared to younger patients. Consequently, some surgeons are reluctant to operate on older patients, especially as other therapeutic options are available. No single large study of MVD in the elderly has been possible due to the small sample size. A meta-analysis and a report based on the National Inpatient Sample in the United States published in 2011 provide a representative large series of the elderly. The conclusions were that MVD in the elderly deserved consideration, but we believe that more clinical data is desirable.

The present study evaluated the safety as well as efficacy of MVD in a group of elderly patients compared with the non-elderly patients, including detailed perioperative and management data.

Results

No decrease in activity of daily living was found in any patient. Complete pain relief without medication was achieved in 77.8% and partial pain relief in 14.8% in the elderly group, and 83.3% and 9.7%, respectively, in the non-elderly group (p = 0.750). Permanent neurological complication was not observed in the elderly group, whereas 5th nerve and 8th nerve complications were observed in the non-elderly group. Rates of preoperative multiple comorbidities and of cardiovascular comorbidity were significantly higher in the elderly group (p<.01). Worsening comorbidity and new pathology at discharge were mainly hypertension in both groups, but glaucoma attack and asthma attack were observed in the elderly group. All pathologies were successfully managed.

Conclusion

MVD for elderly patients with TN can be achieved safely with careful perioperative management. Surgeons should be experienced to shorten the duration of surgical time and reduce narcotic use, and careful assessment of comorbidity and sharing the information with all medical staff is essential. All staff should work as a team to avoid worsening comorbidity and always consider the possibility of unpredictable events in elderly patients.

Editor’s note: Member, Helen Tyzack, recalls that when she was considering having my MVD, her neurosurgeon told her he had conducted this operation on 90 year olds. He made his decision not on age rather on the relative health and condition of a person. If you are elderly, and you are in pain, I recommend you contact one of Medical Advisory Board’s neurosurgeons and seek their advice. The four neurosurgeons on our MAB are:

Associate Professor Mark Dexter (West Sydney) Phone 02 9633 1900
Dr Jeremy Russell (Melbourne) Phone 03 9981 9588
Dr Benjamin Jonker (Sydney) at Central Neurosurgery Phone 1300 17 44 97
Associate Professor Andrew Danks (Melbourne) Phone 03 8513 9906

If you need to travel to any of these specialists, and need financial assistance, please remember that every state of Australia has some form of Patient Travel Assistance Scheme. If you don’t have access to the internet, I recommend you ask your GP to look up the details for you, and print out any necessary forms.

Posted on February 28, 2023 by Lynette Donnelly — 1 Comment

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

STUDY Feasibility of Olive Oil for Reducing Facial Pain of trigeminal neuralgia.

Brief Summary:

This is a 16-week non-blinded, parallel, controlled trial to determine the feasibility and potential efficacy of an olive oil dietary intervention to alleviate facial pain caused by trigeminal neuralgia type 1 (TGN).

Detailed Description:

Trigeminal neuralgia (TGN) pain is debilitating and unpredictable. Alleviation of intensity or frequency to any degree will improve the quality of life of the individuals affected. Current medical treatments for TGN are often not effective. In some cases, the pain is a result of myelin degeneration. If diet can provide the basic building blocks for myelin regrowth, then the investigators may be able to reduce facial pain by supporting the myelin nerve sheath.

Animal studies have shown that a dietary intervention with olive oil favorably impacts myelin but no human study has been conducted to date. The investigators propose undertaking a feasibility study to determine if a comparable intervention may work in a similar way in humans. If olive oil impacts myelin repair, then pain will be decreased by this dietary intervention and quality of life will be improved. However, it is not known if individuals with TNG will be able to consume a diet relatively high in olive oil. Feasibility will include testing the logistics of distributing the olive oil intervention to the study subjects, incorporation of olive oil into the participants’ daily diets, and online/distance monitoring of compliance and reporting of pain intensity, pain frequency, and quality of life. This feasibility study will lay the groundwork for potential future studies examining the efficacy of olive oil on alleviating facial pain caused by TNG and may provide data for a power analysis for a future interventional trial.

https://clinicaltrials.gov/ct2/show/NCT05032573?id=NCT05032573+OR+NCT05217628&draw=2&rank=2&load=cart

Olive Oil Information

Recognized for its’ abundant health benefits, olive oil is being chosen by many consumers as a preferred form of fat in diets and is being recommended by nutritionists and health professionals as one of the best alternative oils to traditional fats and oils. Olive oil has great diversity in how it can be used as an ingredient in recipes and as a food-enhancer.

Olive trees originated in Asia, but are more commonly know as an agricultural product in Mediterranean countries. Olive oil comes from the process of pitting, grinding, and pressing of the olive fruit.

In countries where olive is most highly consumed – Italy, Greece, and Spain, the incidences of cardiovascular disease is low and this is attributed the health benefits olive oil provides. One tablespoon of olive oil contains 120 calories and 14 grams of fat. However, the fat in olive oil is primarily monounsaturated which, when consumed can help reduce blood cholesterol levels leading to improved cardiovascular function.

Other Health Benefits of Olive Oil:

Olive oil is beneficial as an antioxidant since it contains high levels of vitamin E.
When consumed, olive oil promotes digestion, stimulates metabolism, and lubricates mucous membranes (olive oil contains vegetable mucilage that helps protect the gastrointestinal tract).
Olive oil can aid in relieving constipation. Consuming 1 teaspoon of olive oil with lemon juice (preferably on an empty stomach) can promote proper bowel movements.
Olive oil for skin therapy. Olive oil can be added to dry skin acting like a moisturizer and can also be applied to nails to increase nail strength and to promote healthy cuticles.

How to Choose Olive Oil:

Explore how you can replace butter, margarine, and low quality vegetable oils in your cooking especially in preparing salads, sautéed dishes, and sauces.
Purchase olive oil that is labeled as“extra virgin”, which insures that the oil has been cold pressed. Cold pressed olive oil has been produced with freshly harvested olives and has gone through less processing and has not been degraded with heating or chemicals.
A good quality olive oil will be golden yellow in color versus lower quality olive oils that are light green in color.
Note: olive oil will congeal (form as a solid) in the refrigerator, but remains a liquid at room temperature.

When used in moderation, olive oil is a nutritious fat that promotes a great deal of health benefits. Like wines, olive oils will have differences in flavor depending on the region and producer of the oils. Olive oils can also be infused with herbs, garlic, peppers and other flavorful ingredients to add extra excitement to your dishes.

Category: Studies & Research

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The Importance of Sleep for People With Chronic Pain: Current Insights and Evidence

ABSTRACT

Introduction

Prevalence of Sleep Issues and Chronic Pain

Link Between Sleep and Pain

Temporal Relationship Between Sleep and Pain

Relevance for Research and Treatment of Chronic Pain

Intervention Approaches

Support for Change: The Role of Behavior Change Theories

Conclusions

Author Contributions

Peer Review

Acknowledgments

References

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Description

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Podcast – E207 Remote Patient Monitoring with Dr. Krishnan Chakravarthy

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Safety of microvascular decompression for elderly patients with trigeminal neuralgia

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

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