HealthDay News — Cognitive-behavioral therapy (CBT) is superior to a matched education treatment in reducing the interfering effects of pain and other aspects of fibromyalgia, according to a study published online September 20 in Arthritis & Rheumatology.

Jeungchan Lee, PhD, from Massachusetts General Hospital in Boston, and colleagues assessed the effects of CBT on pain catastrophizing and its underlying brain circuitry. The analysis included 98 participants with fibromyalgia who underwent a baseline neuroimaging assessment and were randomly assigned to eight weeks of individual CBT or a matched fibromyalgia education control condition.

The researchers found that CBT produced larger decreases in pain catastrophizing at posttreatment and larger reductions in pain interference and symptom impact. These functional improvements were mediated by decreases in pain catastrophizing in the CBT group. During catastrophizing thoughts at baseline, brain functional connectivity between ventral posterior cingulate cortex (vPCC), a key node of the default mode network, and somatomotor and salience network regions was increased. vPCC connectivity to somatomotor and salience network areas was reduced following CBT.

“These findings contribute to a growing literature highlighting the benefits of nonpharmacologic treatments, including CBT, for chronic pain conditions such as fibromyalgia,” Lee said in a statement. “Identifying the multiple biopsychosocial mechanisms by which these treatments help to alleviate pain may help to facilitate the practice of precision pain medicine and improve treatment outcomes for the many patients suffering from chronic pain.”

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HealthDay News — Cognitive-behavioral therapy (CBT) is superior to a matched education treatment in reducing the interfering effects of pain and other aspects of fibromyalgia, according to a study published online September 20 in Arthritis & Rheumatology.

Jeungchan Lee, PhD, from Massachusetts General Hospital in Boston, and colleagues assessed the effects of CBT on pain catastrophizing and its underlying brain circuitry. The analysis included 98 participants with fibromyalgia who underwent a baseline neuroimaging assessment and were randomly assigned to 8 weeks of individual CBT or a matched fibromyalgia education control condition.

The researchers found that CBT produced larger decreases in pain catastrophizing at posttreatment and larger reductions in pain interference and symptom impact. These functional improvements were mediated by decreases in pain catastrophizing in the CBT group. During catastrophizing thoughts at baseline, brain functional connectivity between ventral posterior cingulate cortex (vPCC), a key node of the default mode network, and somatomotor and salience network regions was increased. vPCC connectivity to somatomotor and salience network areas was reduced following CBT.

“These findings contribute to a growing literature highlighting the benefits of nonpharmacologic treatments, including CBT, for chronic pain conditions such as fibromyalgia,” Lee said in a statement. “Identifying the multiple biopsychosocial mechanisms by which these treatments help to alleviate pain may help to facilitate the practice of precision pain medicine and improve treatment outcomes for the many patients suffering from chronic pain.”

Abstract/Full Text (subscription or payment may be required)

HealthDay News — Fibromyalgia is a risk factor for pain-related exacerbation of opioid use disorder (OUD), according to a study published online March 14 in PAIN.

Orman Trent Hall, DO, from the Ohio State University Wexner Medical Center in Columbus, and colleagues examined interactions between fibromyalgia and OUD using data from 125 individuals (31% with fibromyalgia) recruited from an academic substance use treatment facility. The 2011 American College of Rheumatology Fibromyalgia Survey, along with an original scale measuring pain-related OUD exacerbation (Pain-related OUD Exacerbation Scale [PrOUD ES]), was administered through an electronic survey. The authors also tested the efficacy of PrOUD ES.

The researchers found that patients with fibromyalgia demonstrated significantly greater odds of acknowledging pain-related OUD exacerbations. Furthermore, participants with fibromyalgia acknowledged putting off seeking help out of fear their pain would be unbearable if they stopped using opioids. Additionally, the PrOUD ES had a single-factor solution, strong internal consistency, and construct validity.

“The present work provides evidence of the factor structure, validity, and reliability of a new scale to measure pain-related OUD exacerbations: PrOUD ES,” the authors write. “Given great scientific interest in the intersection of pain and OUD embodied by the National Institutes of Health Helping to End Addiction Long-term initiative, PrOUD ES warrants further study as a patient-reported outcome measure of potential importance.”

Abstract/Full Text

The 14-week, randomized, double-blind, placebo-controlled study (ClinicalTrials.gov Identifier: NCT05273749) included 457 patients with fibromyalgia. Study participants were randomly assigned 1:1 to receive 1 tablet (2.8mg) of TNX-102 SL or placebo for the first 2 weeks, followed by 2 tablets (5.6mg) of TNX-102 SL or placebo for the next 12 weeks. The primary endpoint was the change from baseline to week 14 in daily diary pain severity scores using the weekly averages of the daily numerical rating scale (NRS) scores.

Results showed treatment with TNX-102 SL 5.6mg led to a statistically significant reduction in the weekly average of daily diary pain severity NRS scores compared with placebo (least squares [LS] mean [SE] difference: -0.7 [0.16] units; P =.00005). 

The trial also met all key secondary endpoints, including statistically significant improvements in sleep quality, fatigue, and overall fibromyalgia symptoms and function based on the Fibromyalgia Impact Questionnaire – Revised (FIQ-R). Additionally, TNX-102 SL had a rapid onset of action; separation from placebo was observed at week 1 and was sustained across all 14 weeks  (nominal P <.01 for every week). 

Adverse events reported during the trial included oral hypoesthesia, abnormal taste, oral paresthesia, tongue discomfort, somnolence, headache, and COVID-19.

“These positive data from RESILIENT and previously with RELIEF, with remarkable separation from placebo on pain, sleep, and fatigue, add support to TNX-102 SL’s proposed mechanism of improving sleep quality to improve the syndromal effects of fibromyalgia,” said Gregory Sullivan, MD, Chief Medical Officer of Tonix Pharmaceuticals. “The sublingual formulation of TNX-102 SL, which uses our proprietary Protectic and Angstro technologies, is integral to our treatment paradigm. These technologies enable transmucosal delivery of cyclobenzaprine with distinctive pharmacokinetic properties that include rapid absorption after dosing and bypass of first-pass hepatic metabolism.”

The Company intends to submit a New Drug Application to the Food and Drug Administration in the second half of 2024.

HealthDay News — For patients living with rheumatic and musculoskeletal diseases (RMD), the proportion of those initiating opioids for the first time who transition to long-term use is high, according to a research letter published online May 16 in the Annals of the Rheumatic Diseases.

Yun-Ting Huang, PhD, from the University of Manchester in the United Kingdom, and colleagues examined the proportion of patients with 1 of 6 MD conditions newly initiated on an opioid who transitioned to long-term use. Participants included 841,047 adults with a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), systemic lupus erythematosus (SLE), osteoarthritis (OA), and fibromyalgia (12,260; 5,195; 3,046; 3,081; 796, 276; and 21,189, respectively), without prior cancer. Long-term opioid users were defined using the standard, stringent, and broad definitions.

The researchers found that 1,081,216 new episodes of opioid use were identified among all patients, of whom 16.8, 11.1, and 21.9% transitioned to long-term use using the standard, stringent, and broad definitions, respectively. Among the 6 RMDs, patients with fibromyalgia made up the highest proportion of long-term opioid users (27.4, 20.9, and 33.7 for standard, stringent, and broad definitions, respectively), followed by RA (25.7, 18.5, and 32.3%, respectively) and AxSpA (23.8, 17.3, and 29.6 percent, respectively). OA patients made up the lowest proportion of long-term opioid users (16.4, 10.7, and 21.4 percent, respectively).

“Introduction of prompt interventions, such as medication reviews or deprescribing, to ensure the appropriateness of long-term opioid therapy, and proactive consideration of nonpharmacological treatments for pain relief would also be of benefit to reduce avoidable harms in this patient population,” the authors write.

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