Current Clinical Trial for Fibromyalgia

Overview of the Trial

A clinical trial sponsored by the University of Washington is actively recruiting patients diagnosed with fibromyalgia. The study aims to assess whether a combination of drug therapy and behavioral therapy can effectively alleviate pain severity and enhance physical function in participants.

Understanding Fibromyalgia

Fibromyalgia is often termed an “invisible illness” due to the absence of visible symptoms. However, for those affected, the condition can severely disrupt daily activities, making even minor tasks feel overwhelming. This illness predominantly affects women and is characterized by chronic, widespread musculoskeletal pain, which is frequently accompanied by fatigue, cognitive impairments, and sleep disturbances. Patients may also experience additional health issues such as irritable bowel syndrome, migraines, and temporomandibular joint disorders, alongside regional pain syndromes like back and neck pain.

Causes and Complications

The onset of fibromyalgia symptoms can sometimes be linked to physical trauma, surgery, infections, or significant psychological stress. In other cases, symptoms may develop gradually over time without any identifiable trigger. Psychological, behavioral, and social factors often play a role in the onset and complexity of fibromyalgia, complicating treatment efforts.

Co-occurring Mental Health Conditions

Research indicates that individuals with fibromyalgia frequently experience mental health challenges, including depression, anxiety, obsessive-compulsive disorder, and post-traumatic stress disorder. While cognitive behavioral therapy has shown effectiveness in addressing the psychological aspects of fibromyalgia, its application in clinical settings remains limited.

Non-Pharmacological Therapies

Complementary Treatments

In addition to cognitive behavioral therapy, health education and exercise are prominent non-pharmacological interventions studied for fibromyalgia management. Evidence suggests that these approaches can lead to sustained improvements in functional abilities. Other complementary therapies include trigger-point injections, chiropractic manipulation, tai chi, yoga, acupuncture, and myofascial release therapy. Despite their popularity among patients, there is a lack of controlled trials supporting their efficacy.

Pharmacological Therapies

Currently, there is no cure for fibromyalgia; however, various medications can help manage symptoms. Commonly prescribed medications include analgesics, anti-anxiety agents, skeletal muscle relaxants, antidepressants, anticonvulsants, and alpha-2 agonists.

Combination Behavioral and Drug Therapy for Fibromyalgia

Details of the COMBAT-FM Trial

Led by Dr. Dennis Turk, the COMBAT-FM clinical trial at the University of Washington is examining the impact of combining drug therapy with behavioral treatment for fibromyalgia. This phase III, double-blind, randomized controlled trial will assess changes in pain severity using daily pain diaries and physical function through the Fibromyalgia Impact Questionnaire-Revised.

Study Groups

Participants will be divided into one of four groups:
– Tramadol and Cognitive Behavioral Therapy
– Tramadol and Health Education
– Placebo and Cognitive Behavioral Therapy
– Placebo and Health Education

Individuals assigned to the Tramadol group will receive 50 mg tablets, with a maximum daily dose of 400 mg, while placebo participants will take an inactive tablet. Cognitive behavioral therapy sessions will consist of eight weekly 50-minute tailored meetings, and health education participants will attend eight similar sessions focused on fibromyalgia.

Significance of the Study

The trial’s registration highlights a gap in existing research, noting that “there have been no studies that have evaluated the combination of medication and behavioral health treatment.” The University of Washington’s study aims to enroll 250 eligible participants, having commenced on May 1, 2012, with an anticipated completion date of July 31, 2018.

References

1. Clauw D. Fibromyalgia: A Clinical Review. JAMA. 2014;311(15):1547.
2. Combined Behavioral and Analgesic Trial for Fibromyalgia – ClinicalTrials.gov [Internet]. Clinicaltrials.gov. 2018 [cited 2 March 2018]. Available from: https://clinicaltrials.gov/ct2/show/NCT01598753?recrs=ab&cond=Fibromyalgia&cntry=US&draw=3&rank=12
3. Combined Behavioral and Analgesic Trial for Fibromyalgia [Internet]. Institute of Translational Health Sciences. 2018 [cited 2 March 2018]. Available from: https://www.iths.org/participate/combined-behavioral-and-analgesic-trial-for-fibromyalgia/
4. Fibromyalgia: Practice Essentials, Background, Pathophysiology [Internet]. Medscape. 2018 [cited 2 March 2018]. Available from: https://emedicine.medscape.com/article/329838-overview
5. Fibromyalgia – Symptoms and causes [Internet]. Mayo Clinic. 2018 [cited 2 March 2018]. Available from: https://www.mayoclinic.org/diseases-conditions/fibromyalgia/symptoms-causes/syc-20354780