FibromyalgiaNCT07154498
Effectiveness of CPI With and Without Cognitive BT on Pain QOL in Fibromyalgia Patient
A study testing Conventional physiotherapy with Cognitive Behavior Therapy and Conventional physiotherapy in people with Fibromyalgia, run by Superior University at 1 site in Pakistan.
Trial summary
The study is a randomized clinical trial conducted at Maryam Hospital Burewala, focusing on the treatment of fibromyalgia in adults aged 18 to 65 years. The sample size was 60+6=66, divided into two groups. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Conventional physiotherapy with Cognitive Behavior Therapy and Conventional physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Confirmed diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010/2011 criteria.
- Adults aged 18 to 65 years.
- Both genders was included
- Persistent symptoms of fibromyalgia for at least 6 months.
- Ability and willingness to provide informed consent and comply with study procedures.
Who cannot join
- Presence of other chronic pain conditions that could interfere with the assessment of fibromyalgia symptoms (e.g., rheumatoid arthritis, lupus).
- Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that could impact the ability to participate in the study.
- Current substance abuse or dependence within the past 6 months
- Presence of unstable or severe medical conditions (e.g., uncontrolled diabetes, severe cardiovascular disease) that could affect participation or pose a risk during the study.
- Participation in another clinical trial within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Conventional Physiotherapy Interventions With and Without Cognitive Behavior Therapy on Pain and Quality of Life in Fibromyalgia Patient
The study is a randomized clinical trial conducted at Maryam Hospital Burewala, focusing on the treatment of fibromyalgia in adults aged 18 to 65 years. The sample size was 60+6=66, divided into two groups. The selection criteria included patients with confirmed fibromyalgia diagnosis, persistent symptoms for at least 6 months, and willingness to provide informed consent. Exclusion criteria included other chronic pain conditions, severe psychiatric disorders, substance abuse, unstable medical conditions, or participation in another clinical trial.
Read the detailed description
The Fibromyalgia Impact Questionnaire (FIQ) and the SF-36 questionnaire were used to assess pain intensity, fatigue, sleep quality, and other symptoms. Subjects were divided into two groups and treated with two sessions per week, each lasting about an hour. The study is single-blind, with assessors and physical therapists being aware of the treatment given to both groups. Data analysis will be performed using SPSS version 24, with normality assessed using the Kolmogorov-Smirnov test. A P-value of ≤ 0.05 will be considered significant.
- Conditions
- Fibromyalgia
- Being tested
- Conventional physiotherapy with Cognitive Behavior Therapy, Conventional physiotherapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapy with Cognitive Behavior TherapyBehavioural
Gentle exercises include stretching and strengthening exercises. Cognitive-behavioral therapy (CBT) sessions.
Conventional physiotherapyCombination product
Gentle exercises include stretching and strengthening exercises mobilisation, soft tissue mobilisation Interventions was applied at two sessions per week, each session is about an hour total of 24 sessions. Assessment was done at baseline in the 6th week and 12th week.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physiotherapy with Cognitive Behavior Therapy | Experimental | Not described Receives: Behavioral: Conventional physiotherapy with Cognitive Behavior Therapy |
| Conventional physiotherapy | Active comparator | Not described Receives: Combination Product: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fibromyalgia Impact Questionnaire (FIQ)
The Fibromyalgia Impact Questionnaire (FIQ) is a 10-item, self-administered tool assessing fibromyalgia's impact on physical function, job difficulty, pain, fatigue, and well-being, with a total score from 0 to 100, where higher scores indicate greater impact. The original FIQ uses a 4-point Likert scale for physical function, a 7-day scale for work/feel well days, and visual analog scales (0-10cm) for pain, fatigue, stiffness, anxiety, and depression. Scoring involves normalizing each section and summing them, with specific multipliers and potential adjustments for missing items to reach a total of 100
Measured: 12 Months
The Short Form-36 (SF-36)
The Short Form-36 (SF-36) is a 36-question, patient-reported health survey that measures self-reported health-related quality of life (HRQOL) by assessing eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Responses are scored on a 0-100 scale, where 0 represents maximum disability and 100 represents no disability
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Aug 2024
- Primary completion1 Dec 2024
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154498
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/753
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Conventional Physiotherapy Interventions With and Without Cognitive Behavior Therapy on Pain and Quality of Life in Fibromyalgia Patient
- ClinicalTrials.gov ID
- NCT07154498
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/753
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 4 Sep 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.
The study is a randomized clinical trial conducted at Maryam Hospital Burewala, focusing on the treatment of fibromyalgia in adults aged 18 to 65 years. The sample size was 60+6=66, divided into two groups. The selection criteria included patients with confirmed fibromyalgia diagnosis, persistent symptoms for at least 6 months, and willingness to provide informed consent. Exclusion criteria included other chronic pain conditions, severe psychiatric disorders, substance abuse, unstable medical conditions, or participation in another clinical trial.
Detailed description
The Fibromyalgia Impact Questionnaire (FIQ) and the SF-36 questionnaire were used to assess pain intensity, fatigue, sleep quality, and other symptoms. Subjects were divided into two groups and treated with two sessions per week, each lasting about an hour. The study is single-blind, with assessors and physical therapists being aware of the treatment given to both groups. Data analysis will be performed using SPSS version 24, with normality assessed using the Kolmogorov-Smirnov test. A P-value of ≤ 0.05 will be considered significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physiotherapy with Cognitive Behavior Therapy | Experimental | Behavioral: Conventional physiotherapy with Cognitive Behavior Therapy |
| Conventional physiotherapy | Active comparator | Combination Product: Conventional physiotherapy |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Confirmed diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010/2011 criteria.
- Adults aged 18 to 65 years.
- Both genders was included
- Persistent symptoms of fibromyalgia for at least 6 months.
- Ability and willingness to provide informed consent and comply with study procedures.
Key exclusion criteria (5 listed)
- Presence of other chronic pain conditions that could interfere with the assessment of fibromyalgia symptoms (e.g., rheumatoid arthritis, lupus).
- Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that could impact the ability to participate in the study.
- Current substance abuse or dependence within the past 6 months
- Presence of unstable or severe medical conditions (e.g., uncontrolled diabetes, severe cardiovascular disease) that could affect participation or pose a risk during the study.
- Participation in another clinical trial within the past 30 days.
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 |
|---|---|---|
| Conventional physiotherapy with Cognitive Behavior TherapyGentle exercises include stretching and strengthening exercises. Cognitive-behavioral therapy (CBT) sessions. | Behavioural | Conventional physiotherapy with Cognitive Behavior Therapy |
| Conventional physiotherapyGentle exercises include stretching and strengthening exercises mobilisation, soft tissue mobilisation Interventions was applied at two sessions per week, each session is about an hour total of 24 sessions. Assessment was done at baseline in the 6th week and 12th week. | Combination product | Conventional physiotherapy |
Primary outcome
The Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 12 Months
The Fibromyalgia Impact Questionnaire (FIQ) is a 10-item, self-administered tool assessing fibromyalgia's impact on physical function, job difficulty, pain, fatigue, and well-being, with a total score from 0 to 100, where higher scores indicate greater impact. The original FIQ uses a 4-point Likert scale for physical function, a 7-day scale for work/feel well days, and visual analog scales (0-10cm) for pain, fatigue, stiffness, anxiety, and depression. Scoring involves normalizing each section and summing them, with specific multipliers and potential adjustments for missing items to reach a total of 100
The Short Form-36 (SF-36)
Time frame: 12 Months
The Short Form-36 (SF-36) is a 36-question, patient-reported health survey that measures self-reported health-related quality of life (HRQOL) by assessing eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Responses are scored on a 0-100 scale, where 0 represents maximum disability and 100 represents no disability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy with Cognitive Behavior Therapy and Conventional physiotherapy in people with Fibromyalgia, run by Superior University at 1 site in Pakistan.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 4 Sep 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fibromyalgia Impact Questionnaire (FIQ) (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 4 Sep 2025.