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.

Investigation of patients' understanding of fibromyalgia: Results from an online qualitative survey.

OBJECTIVE: An important component to effective fibromyalgia treatment is patient education about the condition. While previous educational interventions have been developed, these have not incorporated the lived experiences of patients and may not address common misunderstandings among those who may benefit from these interventions. This study aimed to explore understanding, confusion, and gaps in knowledge about fibromyalgia among those who report a fibromyalgia diagnosis. METHODS: Participants were recruited via clinic flyers and the social media page of a chronic pain research laboratory. Participants completed an online survey that assessed their knowledge of fibromyalgia via open-ended questions. Responses were analyzed via thematic analysis to identify, analyze, and report themes. RESULTS: Thirty-eight participants completed the survey (63% female, ages 18-68). Common themes that arose from patients included being unsure of the cause of their fibromyalgia, frustration and confusion about the random/variable nature of symptoms and flares, feeling that their condition was invisible, and desiring more information on available treatments. CONCLUSION: Participants in this study expressed confusion about many aspects of fibromyalgia and a desire for more understanding from others in their life about this condition. PRACTICE IMPLICATIONS: Future interventions would benefit from tailoring fibromyalgia education to the specific knowledge and lived experiences of patients.

The Prevalence and Nature of Eating and Swallowing Problems in Adults with Fibromyalgia: A Systematic Review.

Fibromyalgia is a complex chronic pain condition characterized by widespread pain, fatigue, cognitive dysfunction, and sleep disturbances. People with fibromyalgia can experience both autonomic and somatic disturbances, cognitive and mental health symptoms, and hypersensitivity to external stimuli. Fibromyalgia often co-occurs with a range of well-researched comorbidities (e.g., temporomandibular disorders, migraine, and irritable bowel syndrome). However, emerging research suggests that individuals with fibromyalgia also often experience eating, drinking, and swallowing problems (e.g., odynophagia, glossodynia, etc.). However, there is very little known about these issues, their psychosocial impact, or the best means of managing them clinically. As such, the aim of this research was to examine the epidemiology, prevalence and nature of eating and swallowing problems in adults with fibromyalgia as reported within previous research. A systematic search of electronic databases, selected conference proceedings, and reference lists was completed in March 2021, with no date or language restrictions. Studies reporting the presence and nature of eating and drinking problems in this cohort were included. Eligibility was assessed by two independent reviewers who also critically appraised the included studies using the Joanna Briggs Tool. This literature search yielded a total of 38 potentially eligible studies, with 6 studies included in analysis. Studies were highly heterogeneous in methodology and design, with meta-analysis showing that dysphagia and GERD are prevalent in fibromyalgia patients (51.9% and 25.9%, respectively), among other issues. From review of existing literature, eating and swallowing problems appear to be common among adults with fibromyalgia, with potential additional repercussions for activity, participation, and quality of life. Further research is required to prospectively investigate these issues, with patient and public involvement necessary to guide impactful research planning.

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.

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.

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.

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.