Explain Pain in Fibromyalgia Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 4
- Primary Endpoint
- Change in Visual Analog Scale
Study Overview
Brief Summary
Education of pain physiology is described as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. There is compelling evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophization, and physical performance in chronic musculoskeletal pain disorders. Although pain physiology education has been studied in patients with chronic low back pain, chronic whiplash, and chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM) are limited to a 2013 study with limited results.
The investigators propose a study with a higher dose of education of pain physiology (i.e. a higher number of educational sessions and total education time) to study if this generates a larger treatment effect in patients with fibromyalgia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American College of Rheumatology classification criteria for FM, both 1990 and 2010
- •Reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries
- •On stable doses of medications for FM ≥ 4 weeks
Exclusion Criteria
- •Suffer from an inflammatory rheumatic conditions
- •Have a planned elective surgery during the study period
- •Have ongoing unresolved disability claims
- •Experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis
- •Do not speak Spanish fluently
Arms & Interventions
Educational program High Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
Intervention: Educational program (Other)
Educational program Control Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: talk about medical issues (drugs, nutrition, importance of sleep...)
Intervention: Educational program (Other)
Educational program Diluted Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
Intervention: Educational program (Other)
Educational program Concentrated Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: educational sessions about the neurophysiology of pain
Intervention: Educational program (Other)
Outcomes
Primary Outcomes
Change in Visual Analog Scale
Time Frame: Baseline - 6 weeks - 3 months
On this continuous, horizontal scale used, where 0 is ''no pain" and 100 is ''worst possible pain" (0-100 mm line), subjects will be asked to mark the line with a cross somewhere between both extremes that best reflect their sensation
Secondary Outcomes
- Change in Medical Outcomes Study Short Form 36 (SF-36)(Baseline - 6 weeks - 3 months)
- Change in Fibromyalgia Impact Questionnaire(Baseline - 6 weeks - 3 months)
- Change in Pressure Pain Threshold(Baseline - 6 weeks - 3 months)
- Change in Manual Tender Point Survey(Baseline - 6 weeks - 3 months)
- Change in Patient Global Impression of Change Scale(Baseline - 6 weeks - 3 months)
- Change in Depression subscale of the Hospital Anxiety and Depression Scale(Baseline - 6 weeks - 3 months)
- Change in Fatigue Severity Scale(Baseline - 6 weeks - 3 months)
- Change in Jenkins Sleep Scale(Baseline - 6 weeks - 3 months)
- Change in Neurophysiology of Pain Test(Baseline - 6 weeks - 3 months)
Investigators
J.J. Amer-Cuenca
Head of Department
Cardenal Herrera University