Chronic PainNCT06913868
Consensus-Based vs. Standardized Physiotherapy for Fibromyalgia
A study testing Consensus-Based Physiotherapy Program and Standardized Physiotherapy Care in people with Chronic Pain and Fibromyalgia, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Fibromyalgia
- What is being tested?
- Consensus-Based Physiotherapy Program and Standardized Physiotherapy Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2025to 21 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
Official title: Efficacy of a Consensus-Based Physiotherapy Approach Compared to Standardized Usual Care for the Management of Fibromyalgia: A Multicenter Randomized Controlled 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.
- Conditions
- Chronic Pain, Fibromyalgia
- Being tested
- Consensus-Based Physiotherapy Program, Standardized Physiotherapy Care
- Medical subject headings
- Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consensus-Based Physiotherapy ProgramBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Consensus-Based Physiotherapy | Experimental | Participants in this arm will receive a physiotherapy program based on the Delphi consensus recommendations of Baroni et al. (2023), tailored for individuals with fibromyalgia. This includes pain neuroscience education (approximately 20 minutes per session), tailored exercise therapy (aerobic, strengthening, and sensorimotor exercises with progressive exposure), and emphasis on self-efficacy and coping strategies. The program will be delivered by certified physical therapists trained in the consensus approach. Sessions will be 1-2 times per week for 8 weeks (60 minutes each), with a home exercise program (20 minutes, 3 times per week). Receives: Behavioral: Consensus-Based Physiotherapy Program |
| Usual Physiotherapy Care | Active comparator | Participants in this arm will receive standard physiotherapy care for fibromyalgia as typically provided in outpatient settings. This may include manual therapy, home exercise prescription, and general pain education, but without the structured modules or specific emphasis on the Delphi consensus recommendations. The program will be delivered by certified physical therapists. Sessions will be 1-2 times per week for 8 weeks (60 minutes each), with a home exercise program (20 minutes, 3 times per week). Receives: Behavioral: Standardized Physiotherapy Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks (post-intervention)
Secondary outcomes (5)
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start21 Apr 2025 (estimated)
- Primary completion21 Apr 2028 (estimated)
- Study completion21 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913868
- Sponsor's protocol ID
- NociP-RCT-001
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Consensus-Based Physiotherapy Approach Compared to Standardized Usual Care for the Management of Fibromyalgia: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06913868
- Acronym / sponsor ID
- NociP-RCT-001
- Conditions
- Chronic Pain, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 21 Apr 2025 (estimated)
- Primary completion
- 21 Apr 2028 (estimated)
- Study completion
- 21 Apr 2028 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consensus-Based Physiotherapy | Experimental | Behavioral: Consensus-Based Physiotherapy ProgramParticipants in this arm will receive a physiotherapy program based on the Delphi consensus recommendations of Baroni et al. (2023), tailored for individuals with fibromyalgia. This includes pain neuroscience education (approximately 20 minutes per session), tailored exercise therapy (aerobic, strengthening, and sensorimotor exercises with progressive exposure), and emphasis on self-efficacy and coping strategies. The program will be delivered by certified physical therapists trained in the consensus approach. Sessions will be 1-2 times per week for 8 weeks (60 minutes each), with a home exercise program (20 minutes, 3 times per week). |
| Usual Physiotherapy Care | Active comparator | Behavioral: Standardized Physiotherapy CareParticipants in this arm will receive standard physiotherapy care for fibromyalgia as typically provided in outpatient settings. This may include manual therapy, home exercise prescription, and general pain education, but without the structured modules or specific emphasis on the Delphi consensus recommendations. The program will be delivered by certified physical therapists. Sessions will be 1-2 times per week for 8 weeks (60 minutes each), with a home exercise program (20 minutes, 3 times per week). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consensus-Based Physiotherapy ProgramPhysiotherapy 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. | Behavioural | Consensus-Based Physiotherapy |
| Standardized Physiotherapy CareStandardized 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. | Behavioural | Usual Physiotherapy Care |
Primary outcome
Change in Pain Disability Index (PDI)
Time frame: 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.
5 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Central Sensitization Inventory (CSI)
Time frame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Patient Global Impression of Change (PGIC)
Time frame: 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consensus-Based Physiotherapy Program and Standardized Physiotherapy Care in people with Chronic Pain and Fibromyalgia, run by Al Hayah University In Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed ElMeligie, Ph.D (01159880001, mohamed.elmeligie@ahuc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Disability Index (PDI) (time frame: Baseline, 8 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.