This study compares a new, consensus-based physiotherapy program to standard physiotherapy for people with fibromyalgia. The new program uses recommendations from experts, including education about pain, personalized exercise, and strategies to improve coping skills. We will measure how much pain people have, how well they can function, and their beliefs about pain. The goal is to see if the new program is better than standard care at reducing pain and improving function in individuals with fibromyalgia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Physiotherapy for fibromyalgia (Baroni et al., 2023 Delphi consensus). Includes pain neuroscience education (PNE), tailored aerobic, strengthening, and sensorimotor exercises (graded exposure), and self-management strategies. 8-week program: 1-2 sessions/week (60 min) + home exercise (20 min, 3x/week). Therapist training and fidelity monitoring.Pain Neuroscience Education (PNE): Approximately 20 minutes per session, focusing on explaining the neurobiology of pain in fibromyalgia, emphasizing central sensitization mechanisms, and reconceptualizing pain as an output of the brain rather than solely a marker of tissue damage. PNE aims to reduce threat value associated with pain and improve understanding of pain fluctuations.
Standardized physiotherapy for fibromyalgia. Includes general exercise (aerobic, stretching), manual therapy (within guidelines), and basic pain education (excluding PNE). 8-week program: 1-2 sessions/week (60 min) + home exercise (20 min, 3x/week). Therapist training and fidelity monitoring.
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt
RECRUITINGChange in Pain Disability Index (PDI)
The PDI is a self-report questionnaire that measures the impact of pain on seven domains of daily activities: family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activities. Each domain is rated on a scale of 0-10, with higher scores indicating greater disability. The total score ranges from 0-70. The change from baseline to 8 weeks will be the primary outcome.
Time frame: Baseline, 8 weeks (post-intervention)
Numeric Pain Rating Scale (NPRS)
The NPRS is a single-item scale where patients rate their average pain intensity over the past week on a scale of 0-10, with 0 representing "no pain" and 10 representing "worst imaginable pain."
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ is a 10-item questionnaire that measures a patient's confidence in their ability to perform various activities despite their pain. Each item is rated on a scale of 0-6, with higher scores indicating greater self-efficacy. The total score ranges from 0-60.
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Tampa Scale of Kinesiophobia (TSK)
The TSK is a 17-item questionnaire that measures fear of movement and (re)injury. Items are rated on a 4-point scale (strongly disagree to strongly agree), with higher scores indicating greater kinesiophobia. The total score ranges from 17-68.
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Central Sensitization Inventory (CSI)
The CSI is a 25-item questionnaire that measures the presence and severity of symptoms associated with central sensitization. Part A scores range from 0-100. Higher scores indicate a greater likelihood of central sensitization.
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Patient Global Impression of Change (PGIC)
The PGIC is a single-item scale asking patients to rate their overall improvement since the start of treatment. Patients choose from a 7-point scale: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Time frame: 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
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