Consensus-Based vs. Standardized Physiotherapy for Fibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAl Hayah University In Cairo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Consensus-Based Physiotherapy Program
BehavioralPhysiotherapy 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 Care
BehavioralStandardized 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Consensus-Based PhysiotherapyExperimental treatment 1 intervention
Group B: Usual Physiotherapy CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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)Secondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov