An observational study in Fibromyalgia, sponsored by University of Lahore. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by University of Lahore · Observational
The study will employ a Cross-Sectional Validation Study design. The study will be conducted at the Department of Physical Therapy, University of Lahore Teaching Hospital, located on Defence Road, Lahore.
The anticipated duration of the study will be 09 months, commencing after the approval of the synopsis.
The sample size will be determined following the Kline Method, resulting in a total of 90 participants.
A Purposive Sampling Technique will be utilized to select the study participants.
Study Type: Cross-Sectional Validation Study Location: Department of Physical Therapy, University of Lahore Teaching Hospital, Defence Road, Lahore Duration: 06 months (post-synopsis approval) Sample Size: 90 participants Sampling Technique: Purposive Sampling Consent and Ethics: Participants will provide written informed consent. Ethics approval will be obtained from the University of Lahore Ethics Committee.
Translation of FSS:
The Fatigue Severity Scale (FSS) will be translated into Urdu for data collection.
Two independent bilingual translators will create reports on translation difficulties and rationale.
These reports will inform a consensus meeting to develop a unified Urdu version, with comments documented.
The unified version will be backtranslated into English by native English-speaking translators unaware of the questionnaire's concept.
Expert Committee:
An expert committee comprising physical therapists, linguists, and a methodologist will review both language versions.
The goal is to ensure semantic, idiomatic, experiential, and conceptual equivalence and reach consensus on the final Urdu version of the FSS.
Patient Involvement:
The final Urdu FSS version will be administered to 20 fibromyalgia patients. These patients will also be interviewed to assess their understanding of questionnaire items.
Participants will receive additional information about fibromyalgia to prevent confusion.
Data Collection:
Data will be collected from 100 fibromyalgia patients using the final Urdu FSS version.
A retest will be conducted after 48 hours.
Additional Assessment:
All 90 participants will complete the Multidimensional Fatigue Inventory (MFI).
1,336 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.
This study's enrollment of 90 is close to the median of 100 across 270 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University of Lahore is the lead sponsor of 223 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fibromyalgia is a disease characterized by chronic pain, stiffness, and tenderness of muscles, tendons, and joints, without detectable inflammation. Fibromyalgia does not cause body damage or deformity. Fatigue affects 90 percent of patients and sleep disorders are common. Patients diagnosed with fibromyalgia according to the American College of Rheumatology (ACR) criteria will be included in this study.
Exclusion Criteria:
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a self-reported measure of fatigue and sleep disturbance in patients with fibromyalgia. It is a 9-item scale that assesses the severity of fatigue, the impact of fatigue on daily activities, and the degree of sleep disturbance. The FSS is a widely used instrument in research and clinical practice, and has been found to be a valid and reliable measure of fatigue and sleep disturbance in patients with fibromyalgia. The FSS items are rated on a 5-point Likert scale, with responses ranging from "not at all" to "extremely." The total score ranges from 0 to 36, with higher scores indicating greater levels of fatigue and sleep disturbance.
Time frame: 1 week
Multidimensional Fatigue Inventory
The Multidimensional Fatigue Inventory (MFI) is a self-report questionnaire designed to assess various dimensions of fatigue experienced by individuals. It is commonly used in research and clinical settings to measure and understand fatigue in different contexts. Respondents answer a series of questions related to each dimension on a Likert-type scale, typically ranging from 1 to 5 or 0 to 4. The scores from each dimension are summed to obtain subscale scores, and a total score is often calculated by summing all subscale scores. Higher scores indicate greater levels of fatigue.
Time frame: 1 week
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Lahore