NCT07154498

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Superior University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Conventional physiotherapy with Cognitive Behavior Therapy	Gentle exercises include stretching and strengthening exercises. Cognitive-behavioral therapy (CBT) sessions.
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-01
• Completion: 2025-07-25
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Pakistan