Explain Pain in Fibromyalgia Patients

Cardenal Herrera University

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Educational program

Study type: Interventional

Funder types: Other

Identifiers

NCT02474875

CEI14 / 008

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 4 patient groups

Educational program Control Group

Active Comparator group

Description:

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...)

Treatment:

Other: Educational program

Educational program High Dose Group

Experimental group

Description:

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

Treatment:

Other: Educational program

Educational program Diluted Low Dose Group

Experimental group

Description:

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

Treatment:

Other: Educational program

Educational program Concentrated Low Dose Group

Experimental group

Description:

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

Treatment:

Other: Educational program