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

Superior University

Status

Completed

Conditions

Fibromyalgia

Treatments

Combination Product: Conventional physiotherapy

Behavioral: Conventional physiotherapy with Cognitive Behavior Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07154498

MSRSW/Batch-Fall22/753

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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.