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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Conventional physiotherapy with Cognitive Behavior Therapy; Combination product: Conventional physiotherapy

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Burewala, Punjab Province, Pakistan
      • Maryam Hospital Burewala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional physiotherapy with Cognitive Behavior Therapy	Behavioral: Conventional physiotherapy with Cognitive Behavior Therapy; Gentle exercises include stretching and strengthening exercises. Cognitive-behavioral therapy (CBT) sessions.
Active Comparator: Conventional physiotherapy	Combination product: Conventional physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: August 27, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: MSRSW/Batch-Fall22/753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No