Fibromyalgia (FM)NCT06819930
Assessment of the Functional Capacity of Patients with Fibromyalgia: Clinical Validity
An observational study of Fibromyalgia (FM) and Work Ability, run by University Ramon Llull at 2 sites in Spain.
Trial summary
Fibromyalgia is one of the main causes of chronic pain without a specific etiology, affecting 8% of the Spanish population, especially women. Its most characteristic symptoms include generalized pain, fatigue, difficulty falling asleep, joint stiffness, anxiety, and depression. Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia (FM), Work Ability, Physical Activity
- What is being tested?
- Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation
- How many people
- 160 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Mar 2023to Mar 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will include a total of 160 women, calculated using the Epidat version 3.1 statistical software (University of Santiago de Compostela, Spain). The sample size was estimated based on the average and standard deviation of parameters considered for diagnosing fibromyalgia, the General Pain Index (IDG), and the Symptom Severity Index (EGS). The maximum acceptable error percentage is 5%, accounting for variability in the EGS questionnaire among women with active employment-related fibromyalgia. A confidence level of 95% was used for the calculation. The sample will be divided into four groups, each comprising 40 women to account for a 15% anticipated dropout rate. The groups are as follows: Women with fibromyalgia who are actively working. Women with fibromyalgia on sick leave. Women with fibromyalgia with permanent work disability (officially recognized by the INSS). A control group of sedentary women without fibromyalgia
Who may be able to join
- Women aged between 30 and 64 years old with a diagnosis of fibromyalgia made by a rheumatologist or family doctor following the ACR diagnostic criteria.
- For the control group, women matched by age with no diagnosis of fibromyalgia and with a sedentary lifestyle will be included.
- All participants must agree to be part of the study.
Who cannot join
- Illiteracy and/or lack of understanding of Spanish.
- Severe psychiatric and/or psychological disorders, associated musculoskeletal diseases that could increase pain, such as uncontrolled endocrine disorders, autoimmune diseases, and/or other associated rheumatological or neurological conditions.
- Additionally, patients who refuse to participate in the study or any condition that, in the investigator\'s judgment, would prevent proper adherence to the protocol will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
CAP Vila Olímpica
Barcelona, Barcelona, 08005
Facultat de Psicologia, Ciències de l'Educació i l'Esport (Blanquerna-URL)
Barcelona, Barcelona, 08022
About this study
Official title: Assessment of the Functional Capacity of Patients with Fibromyalgia: Clinical Validity and in the Determination of Work Incapacity
Fibromyalgia is one of the main causes of chronic pain without a specific etiology, affecting 8% of the Spanish population, especially women. Its most characteristic symptoms include generalized pain, fatigue, difficulty falling asleep, joint stiffness, anxiety, and depression. Due to the lack of objective data confirming the condition and the subjectivity of the symptoms, the current diagnosis is purely clinical. Moreover, despite the significant impact on the quality of life of those who suffer from it, there is a lack of scientific evidence to assess the degree to which it affects their functional and work capacity. This concept is gaining relevance in the growing context of patients seeking work disability.
Thus, due to the lack of international consensus and standardized protocols, this study hypothesizes that the functional capacity of Spanish women with fibromyalgia, aged 30 to 64, evaluated with various validated tests such as the six-minute walking test (6MWT), handgrip strength dynamometry, and the 8-foot up \& go, correlates directly with their quality of life, physical activity measured by accelerometry, and social and psychological impact, provided there is no economic benefit. Therefore, the primary aim of this research is to validate a standardized protocol for evaluating the functional and work capacity of Spanish women with fibromyalgia and to assess its correlation with quality of life, physical activity, and psychosocial impact.
Read more
The study will include a total sample of 160 women, divided into four groups of 40 participants: women with fibromyalgia who are actively working, women with fibromyalgia on sick leave, women with fibromyalgia with permanent work disability (officially recognized by the National Institute of Social Security, INSS), and a control group of healthy women.
The patients will be required to attend in person to complete the full protocol, with a one-week interval between sessions. Subsequently, two follow-ups will be conducted at 6 and 12 months, where the work situation will be reassessed, and questionnaires will be administered. The protocol includes the following variables for study: age, weight, height, marital status, country of origin, socioeconomic level, educational level, occupation, work situation, generalized pain index questionnaire, symptom severity questionnaire, fibromyalgia impact questionnaire, allodynia test, six-minute walking test, 8-foot up and go, handgrip strength dynamometry, tender points, false points, SF-36 questionnaire, Hospital Anxiety and Depression Scale, multidimensional perceived social support scale, and accelerometry.
The aim of this study is to analyze in greater depth the validity of the tests currently used in clinics to objectively assess the functional capacity of patients with fibromyalgia. In this way, this study will become the first to present and evaluate the validity and reliability of a protocol for assessing functional capacity. If the proposed hypothesis is proven, these tests and evaluation methods will be highly useful for systematic incorporation into the routine of functional capacity assessment services, as well as in daily clinical practice.
- Conditions
- Fibromyalgia (FM), Work Ability, Physical Activity, Physical Functioning, Physical Performance
- Being tested
- Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluationOther
This study involves a combination of functional tests, questionnaires, and activity measurement using accelerometers. The functional tests include the six-minute walk test (6MWT), handgrip strength dynamometry, and the 8-foot up \& go test. Participants will also complete validated questionnaires assessing symptoms, quality of life, and psychosocial impact. Additionally, accelerometers will be used to objectively measure physical activity levels throughout the study period
| Study group | Role | What they receive |
|---|---|---|
| Women with Fibromyalgia who are actively working | Not described Receives: Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation | |
| Women with Fibromyalgia on sick leave | Not described Receives: Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation | |
| Women with Fibromyalgia with permanent work disability (oficially recognized by the INSS) | Not described Receives: Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation | |
| Control group of sedentary women without Fibromyalgia | Not described Receives: Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of a Standardized Protocol for Functional Capacity Evaluation in Patients with Fibromyalgia
The primary outcome will assess the reliability of a standardized protocol for evaluating the functional capacity of Spanish women with fibromyalgia. The protocol includes the Six-Minute Walk Test (6MWT), handgrip strength dynamometry, and the 8-foot Up \& Go test. These measures will be evaluated for their consistency and accuracy in reflecting functional capacity over a 12-month period.
For each test (6MWT, handgrip strength dynamometry and 8 feet up and go) the unit of measure for reliability will be intraclass correlation coefficient (ICC), measurement error (ME), small detectable change (SDC) and minimal important change (MIC).
Measured: Baseline and 12 months
Validity of a Standardized Protocol for Functional Capacity Evaluation in Patients with Fibromyalgia
The primary outcome will assess the validity of a standardized protocol for evaluating the functional capacity of Spanish women with fibromyalgia. The protocol includes the Six-Minute Walk Test (6MWT), handgrip strength dynamometry, and the 8-foot Up \& Go test. These measures will be evaluated for their consistency and accuracy in reflecting functional capacity over a 12-month period.
For each test (6MWT, handgrip strength dynamometry and 8 feet up and go test) the unit of measure for validity will be correlation coefficient (r).
Measured: Baseline and 12 months
Secondary outcomes (3)
Levels of Physical Activity (light, moderate and vigorous) and sedentary time in Different Fibromyalgia Patient Groups Measured by Triaxial Accelerometers
This outcome will analyze the actual physical activity levels (light, moderate and vigorous) and sedentary time (min) of different patient groups with fibromyalgia-those who are working, those on sick leave, and those with recognized work disability-using triaxial accelerometers. The measure will assess differences in physical activity among these groups over a 12-month period.
Measured: Baseline and 12 months
Convergent Validity of Functional Assessments (6MWT, Handgrip Strength Dynamometry, and 8-Foot Up & Go) Compared to the Self-Administered Functional Impact Questionnaire (FIQ-R)
This outcome will evaluate the convergent validity of the objective functional assessments-Six-Minute Walk Test (6MWT), handgrip strength dynamometry, and 8-Foot Up \& Go test-by comparing them with the self-administered Functional Impact Questionnaire (FIQ-R). The aim is to determine how well these functional tests correlate with the FIQ-R
Measured: Baseline and 12 months
Predictive Validity of Functional Tests for Return to Work, Fibromyalgia Impact (FIQ-R), Short- and Medium-Term Quality of Life, Psychological Impact, and Social Impact
This outcome will estimate the predictive validity of the functional tests (6MWT, handgrip strength dynamometry, and 8-Foot Up \& Go) concerning several factors: return to work, fibromyalgia impact measured by the FIQ-R, short- and medium-term quality of life, psychological impact, and social impact. The aim is to assess how well these functional tests can predict these various outcomes over time. The unit of measure for predictive validity will be correlation coefficient.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start14 Mar 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca Roman-Viñas, MD, University Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819930
- Sponsor's protocol ID
- URamonLlull
- Status last verified
- Feb 2025
- First submitted
- 22 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data (IPD) might not be shared due to concerns related to patient confidentiality and privacy. Given that the study involves sensitive health information, including details about fibromyalgia diagnosis, functional assessments, and personal health conditions, ensuring the protection of participants identities and data is crucial. Sharing IPD could potentially risk breaching patient confidentiality. Additionally, the study may have specific protocols or agreements in place that restrict the dissemination of individual data to protect participant privacy or comply with regulatory requirements. Ensuring proper data management and adhering to ethical standards for patient privacy and data protection are primary considerations that may impact the decision to share IPD. Therefore, while transparency is important, maintaining the confidentiality and security of individual patient data remains a priority.
Publications
Socorro-Cumplido JL, Chaler J, Almirall M, Sanchez-Raya J, Blanch-Rubio J, Castro MJ, Gine-Garriga M, Launois P, Rodriguez-Araya T, Arias Gassol A, Crombez G, Mila Villarroel R, Roman-Vinas B. The value of performance-based tests in the assessment of patients with fibromyalgia: a construct validity and comprehensiveness analysis of a standardized test battery. Front Rehabil Sci. 2026 Sep 11;7:1947752. doi: 10.3389/fresc.2026.1947752. eCollection 2026.
PubMed 42798403
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Functional Capacity of Patients with Fibromyalgia: Clinical Validity and in the Determination of Work Incapacity
- ClinicalTrials.gov ID
- NCT06819930
- Acronym / sponsor ID
- URamonLlull
- Conditions
- Fibromyalgia (FM), Work Ability, Physical Activity, Physical Functioning, Physical Performance
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 11 Feb 2025 (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.
Fibromyalgia is one of the main causes of chronic pain without a specific etiology, affecting 8% of the Spanish population, especially women. Its most characteristic symptoms include generalized pain, fatigue, difficulty falling asleep, joint stiffness, anxiety, and depression. Due to the lack of objective data confirming the condition and the subjectivity of the symptoms, the current diagnosis is purely clinical. Moreover, despite the significant impact on the quality of life of those who suffer from it, there is a lack of scientific evidence to assess the degree to which it affects their functional and work capacity. This concept is gaining relevance in the growing context of patients seeking work disability.
Thus, due to the lack of international consensus and standardized protocols, this study hypothesizes that the functional capacity of Spanish women with fibromyalgia, aged 30 to 64, evaluated with various validated tests such as the six-minute walking test (6MWT), handgrip strength dynamometry, and the 8-foot up \& go, correlates directly with their quality of life, physical activity measured by accelerometry, and social and psychological impact, provided there is no economic benefit. Therefore, the primary aim of this research is to validate a standardized protocol for evaluating the functional and work capacity of Spanish women with fibromyalgia and to assess its correlation with quality of life, physical activity, and psychosocial impact.
The study will include a total sample of 160 women, divided into four groups of 40 participants: women with fibromyalgia who are actively working, women with fibromyalgia on sick leave, women with fibromyalgia with permanent work disability (officially recognized by the National Institute of Social Security, INSS), and a control group of healthy women.
The patients will be required to attend in person to complete the full protocol, with a one-week interval between sessions. Subsequently, two follow-ups will be conducted at 6 and 12 months, where the work situation will be reassessed, and questionnaires will be administered. The protocol includes the following variables for study: age, weight, height, marital status, country of origin, socioeconomic level, educational level, occupation, work situation, generalized pain index questionnaire, symptom severity questionnaire, fibromyalgia impact questionnaire, allodynia test, six-minute walking test, 8-foot up and go, handgrip strength dynamometry, tender points, false points, SF-36 questionnaire, Hospital Anxiety and Depression Scale, multidimensional perceived social support scale, and accelerometry.
The aim of this study is to analyze in greater depth the validity of the tests currently used in clinics to objectively assess the functional capacity of patients with fibromyalgia. In this way, this study will become the first to present and evaluate the validity and reliability of a protocol for assessing functional capacity. If the proposed hypothesis is proven, these tests and evaluation methods will be highly useful for systematic incorporation into the routine of functional capacity assessment services, as well as in daily clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Women with Fibromyalgia who are actively working | – | Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation |
| Women with Fibromyalgia on sick leave | – | Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation |
| Women with Fibromyalgia with permanent work disability (oficially recognized by the INSS) | – | Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation |
| Control group of sedentary women without Fibromyalgia | – | Other: Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluation |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include a total of 160 women, calculated using the Epidat version 3.1 statistical software (University of Santiago de Compostela, Spain). The sample size was estimated based on the average and standard deviation of parameters considered for diagnosing fibromyalgia, the General Pain Index (IDG), and the Symptom Severity Index (EGS). The maximum acceptable error percentage is 5%, accounting for variability in the EGS questionnaire among women with active employment-related fibromyalgia. A confidence level of 95% was used for the calculation. The sample will be divided into four groups, each comprising 40 women to account for a 15% anticipated dropout rate. The groups are as follows: Women with fibromyalgia who are actively working. Women with fibromyalgia on sick leave. Women with fibromyalgia with permanent work disability (officially recognized by the INSS). A control group of sedentary women without fibromyalgia
Key inclusion criteria (3 listed)
- Women aged between 30 and 64 years old with a diagnosis of fibromyalgia made by a rheumatologist or family doctor following the ACR diagnostic criteria.
- For the control group, women matched by age with no diagnosis of fibromyalgia and with a sedentary lifestyle will be included.
- All participants must agree to be part of the study.
Key exclusion criteria (3 listed)
- Illiteracy and/or lack of understanding of Spanish.
- Severe psychiatric and/or psychological disorders, associated musculoskeletal diseases that could increase pain, such as uncontrolled endocrine disorders, autoimmune diseases, and/or other associated rheumatological or neurological conditions.
- Additionally, patients who refuse to participate in the study or any condition that, in the investigator\'s judgment, would prevent proper adherence to the protocol will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Assessments, Questionnaires, and Accelerometry for Fibromyalgia evaluationThis study involves a combination of functional tests, questionnaires, and activity measurement using accelerometers. The functional tests include the six-minute walk test (6MWT), handgrip strength dynamometry, and the 8-foot up \& go test. Participants will also complete validated questionnaires assessing symptoms, quality of life, and psychosocial impact. Additionally, accelerometers will be used to objectively measure physical activity levels throughout the study period | Other | Control group of sedentary women without Fibromyalgia, Women with Fibromyalgia on sick leave, Women with Fibromyalgia who are actively working, Women with Fibromyalgia with permanent work disability (oficially recognized by the INSS) |
Primary outcome
Reliability of a Standardized Protocol for Functional Capacity Evaluation in Patients with Fibromyalgia
Time frame: Baseline and 12 months
The primary outcome will assess the reliability of a standardized protocol for evaluating the functional capacity of Spanish women with fibromyalgia. The protocol includes the Six-Minute Walk Test (6MWT), handgrip strength dynamometry, and the 8-foot Up \& Go test. These measures will be evaluated for their consistency and accuracy in reflecting functional capacity over a 12-month period. For each test (6MWT, handgrip strength dynamometry and 8 feet up and go) the unit of measure for reliability will be intraclass correlation coefficient (ICC), measurement error (ME), small detectable change (SDC) and minimal important change (MIC).
Validity of a Standardized Protocol for Functional Capacity Evaluation in Patients with Fibromyalgia
Time frame: Baseline and 12 months
The primary outcome will assess the validity of a standardized protocol for evaluating the functional capacity of Spanish women with fibromyalgia. The protocol includes the Six-Minute Walk Test (6MWT), handgrip strength dynamometry, and the 8-foot Up \& Go test. These measures will be evaluated for their consistency and accuracy in reflecting functional capacity over a 12-month period. For each test (6MWT, handgrip strength dynamometry and 8 feet up and go test) the unit of measure for validity will be correlation coefficient (r).
3 secondary outcomes
Levels of Physical Activity (light, moderate and vigorous) and sedentary time in Different Fibromyalgia Patient Groups Measured by Triaxial Accelerometers
Time frame: Baseline and 12 months
Convergent Validity of Functional Assessments (6MWT, Handgrip Strength Dynamometry, and 8-Foot Up & Go) Compared to the Self-Administered Functional Impact Questionnaire (FIQ-R)
Time frame: Baseline and 12 months
Predictive Validity of Functional Tests for Return to Work, Fibromyalgia Impact (FIQ-R), Short- and Medium-Term Quality of Life, Psychological Impact, and Social Impact
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Derived from this study: PubMed 42798403Socorro-Cumplido JL, Chaler J, Almirall M, Sanchez-Raya J, Blanch-Rubio J, Castro MJ, Gine-Garriga M, Launois P, Rodriguez-Araya T, Arias Gassol A, Crombez G, Mila Villarroel R, Roman-Vinas B. The value of performance-based tests in the assessment of patients with fibromyalgia: a construct validity and comprehensiveness analysis of a standardized test battery. Front Rehabil Sci. 2026 Sep 11;7:1947752. doi: 10.3389/fresc.2026.1947752. eCollection 2026.
- Individual participant dataSharing planned: No. Individual Patient Data (IPD) might not be shared due to concerns related to patient confidentiality and privacy. Given that the study involves sensitive health information, including details about fibromyalgia diagnosis, functional assessments, and personal health conditions, ensuring the protection of participants identities and data is crucial. Sharing IPD could potentially risk breaching patient confidentiality. Additionally, the study may have specific protocols or agreements in place that restrict the dissemination of individual data to protect participant privacy or comply with regulatory requirements. Ensuring proper data management and adhering to ethical standards for patient privacy and data protection are primary considerations that may impact the decision to share IPD. Therefore, while transparency is important, maintaining the confidentiality and security of individual patient data remains a priority.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia (FM) and Work Ability, run by University Ramon Llull at 2 sites in Spain.
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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reliability of a Standardized Protocol for Functional Capacity Evaluation in Patients with Fibromyalgia (time frame: Baseline and 12 months). 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?
On the ClinicalTrials.gov record for NCT06819930, which also lists 1 linked publication.
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 Feb 2025.