Effectiveness of CPI With and Without Cognitive BT on Pain QOL in Fibromyalgia Patient

NCT07154498 | Completed DMC

• 1 other identifier: MSRSW/Batch-Fall22/753
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 Months

Study Arms (2)

Conventional physiotherapy with Cognitive Behavior Therapy

EXPERIMENTAL

Behavioral: Conventional physiotherapy with Cognitive Behavior Therapy

Conventional physiotherapy

ACTIVE COMPARATOR

Combination Product: Conventional physiotherapy

Interventions

Conventional physiotherapy with Cognitive Behavior Therapy BEHAVIORAL

Gentle exercises include stretching and strengthening exercises. Cognitive-behavioral therapy (CBT) sessions.

Conventional physiotherapy with Cognitive Behavior Therapy

Conventional physiotherapy COMBINATION_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.

Conventional physiotherapy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Maryam Hospital Burewala

Burewala, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: July 25, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)