Chronic Pain, Fibromyalgia
Conditions
Brief summary
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.
Interventions
BEHAVIORALConsensus-Based Physiotherapy Program
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.
BEHAVIORALStandardized Physiotherapy Care
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.
Sponsors
Al Hayah University In Cairo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Age: Adults (≥ 18 years of age). Diagnosis: Diagnosis of fibromyalgia according to the 2016 Revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria (This is the most current and recommended criteria). This requires: Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Scale (SSS) score ≥ 5 OR WPI 3-6 and SSS score ≥ 9. Generalized pain, defined as pain in at least 4 of 5 regions (left upper, right upper, left lower, right lower, axial). Symptoms have been present at a similar level for at least 3 months. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses. Pain Intensity: Average pain intensity of ≥ 4/10 on the Numeric Pain Rating Scale (NPRS) over the past week. (This ensures participants have clinically significant pain). Nociplastic Pain Features: CSI score ≥ 40. TSK score ≥ 37. Informed Consent: Willingness and ability to provide written informed consent.
Exclusion criteria
Red Flags: Presence of red flags indicating serious underlying pathology that could mimic fibromyalgia or contraindicate exercise, such as: Unexplained weight loss. Fever or night sweats. Recent significant trauma. Neurological signs suggestive of spinal cord compression (e.g., bowel or bladder dysfunction, saddle anesthesia). Suspected malignancy. Acute inflammatory disease. Neurological Disorders: Significant neurological deficits (e.g., multiple sclerosis, Parkinson's disease) that would interfere with participation in the study or confound outcome assessment. Psychiatric Disorders: Uncontrolled or severe psychiatric disorders (e.g., active psychosis, severe major depression with suicidal ideation) that would preclude informed consent or adherence to the study protocol. Note: Mild to moderate, stable depression or anxiety, common in fibromyalgia, should not be an exclusion criterion. Overlapping Pain Conditions: Presence of other significant, active pain conditions that could confound the assessment of fibromyalgia-related pain and function, such as: Active inflammatory arthritis (e.g., rheumatoid arthritis, lupus) requiring ongoing systemic treatment. Severe osteoarthritis requiring imminent joint replacement. Active, untreated neuropathic pain conditions (e.g., diabetic neuropathy, post-herpetic neuralgia). Note: Stable, well-managed comorbidities should not be exclusionary. Current Pain Management: Current participation in other pain management programs or interventions that specifically overlap with the study interventions (e.g., another structured physiotherapy program, cognitive behavioral therapy specifically for pain). Note: Patients on stable doses of pain medication should not be excluded. Exercise Contraindications: Inability to participate in exercise therapy due to medical conditions (e.g., severe cardiovascular disease, uncontrolled hypertension). Pregnancy: Current pregnancy or planning to become pregnant during the study period. (Pregnancy can affect pain perception and exercise tolerance). Medication Changes: Recent changes (within the past 4 weeks) in pain-related medications (e.g., opioids, antidepressants, anticonvulsants) or planned changes during the study period. Note: Stable medication regimens are acceptable. Litigation: Current involvement in litigation related to their fibromyalgia or chronic pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Disability Index (PDI) | Baseline, 8 weeks (post-intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up | 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. |
| Pain Self-Efficacy Questionnaire (PSEQ) | Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up | 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. |
| Tampa Scale of Kinesiophobia (TSK) | Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up | 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. |
| Central Sensitization Inventory (CSI) | Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up | 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. |
| Patient Global Impression of Change (PGIC) | 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up | 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. |
Countries
Egypt
Contacts
Primary ContactMohamed ElMeligie, Ph.D
Outcome results
None listed