FibromyalgiaNCT06031207
Translation and Psychometric Properties of the Fatigue Severity Scale in Patients With Fibromyalgia
An observational study of Fibromyalgia, run by University of Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Both genders with age of 18 years and above
- Diagnosed and referred patients of fibromyalgia according to the American College of Rheumatology (ACR) criteria.
- The ability to provide informed consent and wiling to participate in the study.
- Fluency in the study language (i.e. Urdu in this case).
Who cannot join
- Any other chronic pain condition that could affect fatigue and sleep.
- Diagnosed sleep disorder (such as sleep apnea or insomnia) that could affect the results.
- History of a psychiatric disorder that could affect the results.
- History of substance abuse.
- Participation in any other study that could affect the results at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 55150
About this study
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.
Read the detailed description
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).
- Conditions
- Fibromyalgia
- Keywords
- Fatigue Severity Scale, Translation, Psychometric Properties
- Medical subject headings
- Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Sep 2023
- Primary completion20 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Memona Khan, MSPT MSK*, Principal investigator, University of LahoreHafiza Sana Ashraf, MSPT MSK, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031207
- Sponsor's protocol ID
- REC-UOL-492-08-2023
- Status last verified
- Sep 2023
- First submitted
- 3 Sep 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Psychometric Properties of the Fatigue Severity Scale in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06031207
- Acronym / sponsor ID
- REC-UOL-492-08-2023
- Conditions
- Fibromyalgia
- Keywords
- Fatigue Severity Scale, Translation, Psychometric Properties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Both genders with age of 18 years and above
- Diagnosed and referred patients of fibromyalgia according to the American College of Rheumatology (ACR) criteria.
- The ability to provide informed consent and wiling to participate in the study.
- Fluency in the study language (i.e. Urdu in this case).
Key exclusion criteria (5 listed)
- Any other chronic pain condition that could affect fatigue and sleep.
- Diagnosed sleep disorder (such as sleep apnea or insomnia) that could affect the results.
- History of a psychiatric disorder that could affect the results.
- History of substance abuse.
- Participation in any other study that could affect the results at the time of recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue Severity Scale
Time frame: 1 week
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.
Multidimensional Fatigue Inventory
Time frame: 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Memona Khan, MSPT MSK* principal investigator
University of Lahore
Hafiza Sana Ashraf, MSPT MSK study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.