Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial.

BACKGROUND: International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients. We aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management. METHODS: In the PROSPER-FM randomised clinical trial conducted at 25 US community sites, adult participants aged 22-75 years with fibromyalgia were recruited and randomly assigned (1:1) to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials. Randomisation was done with a web-based system in permuted blocks of four at the site level. We used a blind-to-hypothesis approach in which participants were informed they would be randomly assigned to one of two potentially effective therapies under evaluation. Research staff were not masked to group allocation, with the exception of a masked statistics group while preparing statistical programming for the interim analysis. The primary endpoint was patient global impression of change (PGIC) response rate at week 12. Analyses were by intention to treat. The trial was registered with ClinicalTrials.gov, NCT05243511 (now fully closed). FINDINGS: Between Feb 8, 2022, and Feb 2, 2023, 590 individuals were screened, of whom 275 (257 women and 18 men) were randomly assigned to the digital ACT group (n=140) and the active control group (n=135). At 12 weeks, 99 (71%) of 140 ACT participants reported improvement on PGIC versus 30 (22%) of 135 active control participants, corresponding to a difference in proportions of 48·4% (95% CI 37·9-58·9; p<0·0001). No device-related safety events were reported. INTERPRETATION: Digital ACT was safe and efficacious compared with digital symptom tracking in managing fibromyalgia in adult patients. FUNDING: Swing Therapeutics.

Low-dose naltrexone's utility for non-cancer centralized pain conditions: a scoping review.

BACKGROUND: At low doses, naltrexone (LDN) has been shown to modulate inflammation through the interruption of microglial cell activation within the central nervous system. One of the most likely contributors to centralized pain is changes in microglial cell processing. Therefore, it has been postulated that LDN can be used to manage patients with pain resulting from central sensitization due to this relationship. This scoping review aims to synthesize the relevant study data for LDN as a novel treatment strategy for various centralized pain conditions. METHODS: A comprehensive literature search was conducted in PubMed, Embase, and Google Scholar, guided by the Scale for Assessment of Narrative Review Articles (SANRA) criteria. RESULTS: Forty-seven studies related to centralized pain conditions were identified. Many of the studies were case reports/series and narrative reviews, but a few randomized control trials have been conducted. Overall, the body of evidence revealed improvement in patient-reported pain severity and in outcomes related to hyperalgesia, physical function, quality of life, and sleep. Variability in dosing paradigms and the time to patient response was present in the reviewed studies. CONCLUSIONS: Evidence synthesized for this scoping review supports the ongoing use of LDN for the treatment of refractory pain in various centralized chronic pain conditions. Upon review of the currently available published studies, it is apparent that further high-quality, well-powered randomized control trials need to be conducted to establish efficacy, standardization for dosing, and response times. In summary, LDN continues to offer promising results in the management of pain and other distressing symptoms in patients with chronic centralized pain conditions.

Myofascial pain - A major player in musculoskeletal pain.

Myofascial pain is a soft tissue pain syndrome with local and referred musculoskeletal pain arising from trigger points. Myofascial pain and myofascial pain syndromes are among some of the most common acute and chronic pain conditions. Myofascial pain can exist independently of other pain generators or can coexist with or is secondary to other acute and chronic painful musculoskeletal conditions. Myofascial pain is most effectively treated with a multimodal treatment plan including injection therapy (known as trigger point injections, physical therapy, postural or ergonomic correction, and treatment of underlying musculoskeletal pain generators. The objectives of this review are to outline the prevalence of myofascial pain, describe the known pathophysiology of myofascial pain and trigger points, discuss the clinical presentation of myofascial pain, and present evidence-based best practices for pharmacologic, non-pharmacologic, and interventional treatments for myofascial pain.

Localized and Widespread Chronic Pain in Sexual and Gender Minority People - An Analysis of The PRIDE Study.

Sex related differences, without taking gender into account, in chronic pain have been widely researched over the past few decades in predominantly cisgender and heterosexual populations. Historically, chronic pain conditions have a higher incidence and prevalence in cisgender women, including but not limited to fibromyalgia, irritable bowel syndrome, and migraine. The goal of the present study was to identify and characterize the presence and characteristics of chronic pain in SM and GM persons using data from The PRIDE Study, which is the first large-scale, long-term national cohort health study of people who identify as lesbian, gay, bisexual, transgender, queer, or as another sexual or gender minority person. A total of 6189 adult participants completed The PRIDE Study 2022 Annual Questionnaire at the time of data analysis. A total of 2462 participants reported no chronic pain, leaving 2935 participants who reported experiencing chronic pain. The findings from this study highlight that chronic pain is present to a significant degree in sexual and gender minority adults who participated in The PRIDE Study with chronic spine pain being the most common location/region of pain. Notably, more than one-third of non-binary persons, transgender men, and people who selected another gender experienced chronic widespread pain, defined by having 3 or more total regions of chronic pain. The lowest prevalence of chronic widespread pain was among transgender women and cisgender men. When considering sexual orientation, the highest prevalence of widespread pain was in participants who selected another sexual orientation, followed by queer and asexual, demisexual, gray ace, with the lowest prevalence of chronic widespread pain being in those who identify as straight or heterosexual, bisexual, pansexual, gay, and lesbian. Future studies are planned to elucidate how a variety of biopsychosocial mechanisms may influence chronic pain in sexual and gender minority persons.

Musculoskeletal and Neuropathic Pain in COVID-19.

Chronic pain constitutes a significant disease burden globally and accounts for a substantial portion of healthcare spending. The COVID-19 pandemic contributed to an increase in this burden as patients presented with musculoskeletal or neuropathic pain after contracting COVID-19 or had their chronic pain symptoms exacerbated by the virus. This extensive literature review analyzes the epidemiology of pain pre-pandemic, the costs associated with the COVID-19 pandemic, the impact of the virus on the body, mechanisms of pain, management of chronic pain post-pandemic, and potential treatment options available for people living with chronic pain who have had or are currently infected with COVID-19.

Concepts and Approaches in the Management of Transgender and Gender-Diverse Patients.

The terms transgender and gender diverse (TGD) describe persons whose gender is different from the sex assigned to them at birth. While TGD persons have experienced a rise in cultural and social visibility in recent decades, they continue to experience significant health inequities, including adverse health outcomes and multiple barriers to accessing medical care. Transgender and gender-diverse persons are at a higher risk for pain conditions than their cisgender counterparts, but research on chronic pain management for TGD persons is lacking. Clinicians from all disciplines must be informed of best practices for managing chronic pain in the TGD population. This includes all aspects of care including history, physical examination, diagnosis, treatment, and perioperative management. Many TGD persons report delaying or avoiding care because of negative interactions with medical practitioners who do not have sufficient training in navigating the specific health care needs of TGD patients. Furthermore, TGD persons who do seek care are often forced to educate their practitioners on their specific health care needs. This paper provides an overview of existing knowledge and recommendations for physicians to provide culturally and medically appropriate care for TGD persons.

Use of corticosteroids for adult chronic pain interventions: sympathetic and peripheral nerve blocks, trigger point injections - guidelines from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, the American Society of Interventional Pain Physicians, the International Pain and Spine Intervention Society, and the North American Spine Society.

BACKGROUND: There is potential for adverse events from corticosteroid injections, including increase in blood glucose, decrease in bone mineral density and suppression of the hypothalamic-pituitary axis. Published studies note that doses lower than those commonly injected provide similar benefit. METHODS: Development of the practice guideline was approved by the Board of Directors of American Society of Regional Anesthesia and Pain Medicine with several other societies agreeing to participate. The scope of guidelines was agreed on to include safety of the injection technique (landmark-guided, ultrasound or radiology-aided injections); effect of the addition of the corticosteroid on the efficacy of the injectate (local anesthetic or saline); and adverse events related to the injection. Based on preliminary discussions, it was decided to structure the topics into three separate guidelines as follows: (1) sympathetic, peripheral nerve blocks and trigger point injections; (2) joints; and (3) neuraxial, facet, sacroiliac joints and related topics (vaccine and anticoagulants). Experts were assigned topics to perform a comprehensive review of the literature and to draft statements and recommendations, which were refined and voted for consensus (≥75% agreement) using a modified Delphi process. The United States Preventive Services Task Force grading of evidence and strength of recommendation was followed. RESULTS: This guideline deals with the use and safety of corticosteroid injections for sympathetic, peripheral nerve blocks and trigger point injections for adult chronic pain conditions. All the statements and recommendations were approved by all participants after four rounds of discussion. The Practice Guidelines Committees and Board of Directors of the participating societies also approved all the statements and recommendations. The safety of some procedures, including stellate blocks, lower extremity peripheral nerve blocks and some sites of trigger point injections, is improved by imaging guidance. The addition of non-particulate corticosteroid to the local anesthetic is beneficial in cluster headaches but not in other types of headaches. Corticosteroid may provide additional benefit in transverse abdominal plane blocks and ilioinguinal/iliohypogastric nerve blocks in postherniorrhaphy pain but there is no evidence for pudendal nerve blocks. There is minimal benefit for the use of corticosteroids in trigger point injections. CONCLUSIONS: In this practice guideline, we provided recommendations on the use of corticosteroids in sympathetic blocks, peripheral nerve blocks, and trigger point injections to assist clinicians in making informed decisions.

Trigger Point Injections.

Myofascial pain and myofascial pain syndromes are among some of the most common acute and chronic pain conditions. Many interventional procedures can be performed in both an acute and chronic pain setting to address myofascial pain syndromes. Trigger point injections can be performed with or without imaging guidance such as fluoroscopy and ultrasound; however, the use of imaging in years past has been recommended to improve patient outcome and safety. Injections can be performed using no injectate (dry needling), or can involve the administration of local anesthetics, botulinum toxin, or corticosteroids.

Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review.

Perioperative pain management is a unique challenge in patients undergoing spine surgery due to the increased incidence of both pre-existing chronic pain conditions and chronic postsurgical pain. Peri-operative planning and counseling in spine surgery should involve an interdisciplinary approach that includes consideration of patient-level risk factors, as well as pharmacologic and non-pharmacologic pain management techniques. Consideration of psychological factors and patient focused education as an adjunct to these measures is paramount in developing a personalized perioperative pain management plan. Understanding the currently available body of knowledge surrounding perioperative opioid management, management of opioid use disorder, regional/neuraxial anesthetic techniques, ketamine/lidocaine infusions, non-opioid oral analgesics, and behavioral interventions can be useful in developing a comprehensive, multi-modal treatment plan among patients undergoing spine surgery. Although many of these techniques have proved efficacious in the immediate postoperative period, long-term follow-up is needed to define the impact of such approaches on persistent pain and opioid use. Future techniques involving the use of precision medicine may help identify phenotypic and physiologic characteristics that can identify patients that are most at risk of developing persistent postoperative pain after spine surgery.

Autonomic nervous system markers of music-elicited analgesia in people with fibromyalgia: A double-blind randomized pilot study.

Purpose: To investigate the feasibility of using music listening by adults with fibromyalgia (FM) as a potential tool for reducing pain sensitivity. Patients and methods: We report results from a double-blind two-arm parallel randomized pilot study (NCT04059042) in nine participants with FM. Pain tolerance and threshold were measured objectively using quantitative sensory tests; autonomic nervous system (ANS) reactivity was measured with an electrocardiogram. Participants were randomized to listen to instrumental Western Classical music or a nature sound control to test whether music listening elicits greater analgesic effects over simple auditory distraction. Participants also completed separate control testing with no sound that was counterbalanced between participants. Results: Participants were randomized 1:1 to music or nature sounds (four Music and five Nature). Although the groups were not different on FM scores, the Music group had marginally worse temporal pain summation (p = 0.06), and the Nature group had higher anxiety scores (p < 0.05). Outcome measures showed a significant difference between groups in the magnitude of change in temporal summation between sessions (p < 0.05), revealing that the Nature group had greater pain reduction during audio compared to silence mode, while the Music group had no difference between the sessions. No significant effects were observed for either mechanical pain tolerance or ANS testing. Within the Music group, there was a trend of vagal response increase from baseline to music listening, but it did not reach statistical significance; this pattern was not observed in the Nature group. Conclusion: Auditory listening significantly altered pain responses. There may be a greater vagal response to music vs. nature sounds; however, results could be due to group differences in pain and anxiety. This line of study will help in determining whether music could be prophylactic for people with FM when acute pain is expected.

Utilization of Low-Dose Naltrexone for Burning Mouth Syndrome: A Case Report.

Burning mouth syndrome is a chronic pain condition characterized by a burning sensation of the oropharynx. The pathophysiology of burning mouth syndrome includes peripheral and central sensitization. Treatment is generally aimed at symptom reduction. We describe a woman in her seventh decade with burning mouth syndrome that had been refractory to treatment for nearly a decade. Low-dose naltrexone has been reported to provide analgesia in central sensitization states and was successful in reducing pain severity in our patient. We conclude that low-dose naltrexone may be a therapeutic option for patients with burning mouth syndrome who are refractory to conventional therapies.

The impact of foot shock-induced stress on pain-related behavior associated with burn injury.

Acute pain is prevalent following burn injury and can often transition to chronic pain. Prolonged acute pain is an important risk factor for chronic pain and there is little preclinical research to address this problem. Using a mouse model of second-degree burn, we investigated whether pre-existing stress influences pain(sensitivity) after a burn injury. We introduced a contribution of stress in two different ways: (1) the use of foot-shock as a pre-injury stressor or (2) the use of A/J mice to represent higher pre-existing stress compared to C57Bl/6 mice. C57Bl/6 and A/J mice were exposed to repeated mild foot shock to induce stress for 10 continuous days and mice underwent either burn injury or sham burn injury of the plantar surface of the right hind paw. Assessments of mechanical and thermal sensitivities of the injured and uninjured paw were conducted during the shock protocol and at intervals up to 82-day post-burn injury. In both strains of mice that underwent burn injury, thermal hypersensitivity and mechanical allodynia appeared rapidly in the ipsilateral paw. Mice that were stressed took much longer to recover their hind paw mechanical thresholds to baseline compared to non-stressed mice in both burn and non-burn groups. Analysis of the two mouse strains revealed that the recovery of mechanical thresholds in A/J mice which display higher levels of baseline anxiety was shorter than C57Bl/6 mice. No differences were observed regarding thermal sensitivities between strains. Our results support the view that stress exposure prior to burn injury affects mechanical and thermal thresholds and may be relevant to as a risk factor for the transition from acute to chronic pain. Finally, genetic differences may play a key role in modality-specific recovery following burn injury.