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Completed

NCT Number: NCT07154498

Effectiveness of CPI With and Without Cognitive BT on Pain QOL 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryam Hospital Burewala

Burewala, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional physiotherapy with Cognitive Behavior Therapy

Behavioral

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

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.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Effectiveness of Conventional Physiotherapy Interventions With and Without Cognitive Behavior Therapy on Pain and Quality of Life in Fibromyalgia Patient

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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