FibromyalgiaNCT04049006

Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients

A study testing complex treatment in people with Fibromyalgia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Fibromyalgia
What is being tested?: complex treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 302 participants
Where: 1 siteSpain
Study dates: 1 Apr 2019to 31 Mar 2021
Phase: Interventional
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Have a clinical diagnosis of fibromyalgia
Have a fixed or mobile telephone
Voluntarily accept participation in the project

Who cannot join

Active psychotic outbreak;
Intellectual deficiency;
Severe depression and personality disorder;
Self and hetero-aggressive behaviors;
Individual assessment of active consumption of psychoactive substances;
Incompatibility with the group's schedule.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Institut Català de la Salut
Tortosa, Tarragona, 43500

Other trials in Spain

About this study

Official title: Primary Care as a Promoter of the Quality of Life of Fibromyalgia Patients. Effectiveness and Cost-utility of a Complex Intervention Through a Randomized Clinical Trial

Fibromyalgia (FM) is a chronic disease characterized by chronic pain, fatigue and loss of function that leads to a significant deterioration in the quality of life. Despite controversies about the most appropriate treatment, studies indicate that a multidisciplinary treatment would be effective. This study aims to analyze the effectiveness and cost-utility of a complex intervention in the quality of life (main variable), the functional impact, the mood and the pain of people with FM treated in the Primary Care Teams (PCTs) of the Catalan Institute of Health (CIH).

Read the detailed description

Methods and analysis: Mixed methodology study following the recommendations of the Medical Research Council, with two phases. Phase 1: Randomized pragmatic clinical trial with patients diagnosed with FM and assigned to one of the 11 PCTs of the CIH (Territorial management of "Terras del Ebro"). A total sample of 336 patients is estimated.

The usual clinical practice will be carried out in the control group and the usual practice and the complex treatment, in the intervention group. The complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. Statistical analysis: Assessment of the standardized mean response and of the size of the standardized effect and multivariate logistic regression analysis will be performed. The economic analysis will be based on useful measures. Phase 2: Qualitative socio-constructivist study to identify the improvement aspects of the intervention according to the results obtained and the opinions and experiences of the participants (patients and professionals). The sampling will be theoretical with 2 discussion groups composed of participants in the intervention and 2 discussion groups of professionals from different PCTs.

Conditions: Fibromyalgia
Being tested: complex treatment
Keywords: Quality of life, randomized Controlled trials, Costs and Cost analysis, Primary Health Care
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

complex treatmentOther
The complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. The sessions will be conducted in the primary health care by trained professionals.

Study groups in NCT04049006
Study group	Role	What they receive
complex-treatment benefiting group	Experimental	Participants in the intervention group will receive the complex treatment and the usual clinical practice. Receives: Other: complex treatment
complex-treatment no benefiting group	No intervention	Participants in the control group will receive the care from the usual clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in life quality
to be evaluated with the health questionnaire (SF-36v2). It will be measured by a scale Likert: 0 (worst) to 100 (best).
Measured: change from life quality at 3, 9 and 15 months after the beginning of the study
Change in functional impact of fibromyalgia
to be evaluated with the Revised Questionnaire on the Impact of Fibromyalgia (FIQR) It will be measured by a scale Likert: 0 (best) to 100 (worst).
Measured: Change from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study.
Change in tender points
Tender points evaluate the presence of pain in 18 areas of the body and will be measured by a scale Likert: 0 (best) to 18 (worst).
Measured: Change from tender points at 3, 9 and 15 months after the beginning of the study.
Change in Visual Analog Scale for pain (VAS)
The VAS evaluates the self-perceived intensity of pain by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).
Measured: Change from VAS at 3, 9 and 15 months after the beginning of the study.
Change in mood indicator (anxiety)
To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).
Measured: Change from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study.
Change in mood indicator (depression)
To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).
Measured: Change from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study.

Secondary outcomes (20)

Sociodemographic characteristics of the patients
age, sex, level of education, work disability and family coexistence
Measured: baseline (pre intervention period)
Presence/absence of physical manifestations
Physical manifestations to be evaluated: non-repairing sleep, excessive fatigue, dryness of mucous membranes, Raynaud's phenomenon, Intolerance to olfactory and auditory stimuli, cephalgia lumbar, increased sensitivity to the side effects of drugs and paresthesia of hands and feet. To be evaluated with a questionnaire (yes/no type)
Measured: baseline (pre intervention period)
Presence/absence of physical or psychic trigger factor of fibromyalgia
To be evaluated with a questionnaire (yes/no type)
Measured: baseline (pre intervention period)
Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance
To be evaluated with a questionnaire (yes/no type)
Measured: baseline (pre intervention period)
Presence/absence of family history of fibromyalgia
To be evaluated with a questionnaire (yes/no type)
Measured: baseline (pre intervention period)
presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory
To be evaluated with a questionnaire (yes/no type)
Measured: baseline (pre intervention period)
presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain
To be evaluated with a questionnaire (yes/no type)
Measured: baseline (pre intervention period)
Diagnosis date
diagnosis date of fibromyalgia
Measured: baseline (pre intervention period)
Years of evolution
years of evolution of fibromyalgia
Measured: baseline (pre intervention period)
presence/absence of pathological history: arthrosis, arthritis and mental health problems
To be evaluated with a questionnaire (yes/no type)
Measured: baseline (pre intervention period)
Test of the thyroid stimulating hormone
Analytic results in milliunits per litre (mUI/L)
Measured: baseline (pre intervention period)
Hemogram
Analytic results of hemogram
Measured: baseline (pre intervention period)
Glucose, creatinine and C-reactive protein tests
Analytic results of each test in mg/dl
Measured: baseline (pre intervention period)
Liver Function Tests
Analytic results of each test
Measured: baseline (pre intervention period)
Globular sedimentation rate
Analytic results in mm
Measured: baseline (pre intervention period)
Rheumatoid factor
Analytic results in IU/mL
Measured: baseline (pre intervention period)
Pharmacy billing cost
antidepressants, analgesics and others
Measured: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of visits
cost of visits to family doctor or nurse and cost of urgency visits
Measured: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of referrals
cost of referrals to external consultations
Measured: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of lost productivity
cost of lost productivity due to sick leave
Measured: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201931 Mar 2021

First posted7 Aug 2019
Study start1 Apr 2019
Primary completion31 Mar 2021
Study completion31 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04049006
Sponsor's protocol ID: PI1800943
Status last verified: Aug 2019
First submitted: 22 May 2019
Last updated: 7 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Some individual participant data collected during the qualitative phase of the study, after deidentification, will be published in articles. Some articles were already published. Grouped (not individual) participant data that underlie the quantitative results of the trial (and also qualitative results) will be published in text, tables, or figures. The quantitative results were not yet published. Study protocols and patients' qualitative data of this project were already published.

Publications

Caballol Angelats R, Goncalves AQ, Aguilar Martin C, Sancho Sol MC, Gonzalez Serra G, Casajuana M, Carrasco-Querol N, Fernandez-Saez J, Dalmau Llorca MR, Abellana R, Berenguera A; SensiTEbre group. Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: A mixed methods study protocol. Medicine (Baltimore). 2019 Oct;98(41):e17289. doi: 10.1097/MD.0000000000017289.
PubMed 31593081
Arfuch VM, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Goncalves AQ, Berenguera A. Assessing the benefits on quality of life of a multicomponent intervention for fibromyalgia syndrome in primary care: patients' and health professionals' appraisals: a qualitative study protocol. BMJ Open. 2020 Nov 11;10(11):e039873. doi: 10.1136/bmjopen-2020-039873.
PubMed 33177139
Arfuch VM, Aguilar Martin C, Berenguera A, Caballol Angelats R, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Fernandez Saez J, Goncalves AQ, Casajuana M. Cost-utility analysis of a multicomponent intervention for fibromyalgia syndrome in primary care versus usual clinical practice: study protocol for an economic evaluation of a randomised control trial. BMJ Open. 2021 Feb 5;11(2):e043562. doi: 10.1136/bmjopen-2020-043562.
PubMed 33550259
Arfuch VM, Queiroga Goncalves A, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Berenguera A. Patients' appraisals about a multicomponent intervention for fibromyalgia syndrome in primary care: a focus group study. Int J Qual Stud Health Well-being. 2021 Dec;16(1):2005760. doi: 10.1080/17482631.2021.2005760.
PubMed 34839810
Arfuch VM, Caballol Angelats R, Aguilar Martin C, Goncalves AQ, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Friberg E, Berenguera A. Patients' Lived Experience in a Multicomponent Intervention for Fibromyalgia Syndrome in Primary Care: A Qualitative Interview Study. Int J Environ Res Public Health. 2022 Oct 15;19(20):13322. doi: 10.3390/ijerph192013322.
PubMed 36293900
Caballol Angelats R, Goncalves AQ, Abellana R, Carrasco-Querol N, Pamies Corts A, Gonzalez Serra G, Gracia Benaiges D, Sancho Sol MC, Fuste Anguera I, Chavarria Jordana S, Cuevas Baticon B, Batlle Escolies G, Fibla Reverte M, Espuny Valles N, Buera Pitarque N, Marti Cavalle M, Suazo NP, Estivill Bargallo J, Lopez Guerrero MA, Lopez Guerrero C, Perez Acin P, Matamoros Callarisa I, Baucells J, Suazo Ciurana A, Fernandez-Saez J, Dalmau Llorca MR, Berenguera A, Aguilar Martin C. Effectiveness of a Multicomponent Program for Fibromyalgia Patients in a Primary Care Setting (FIBROCARE Program): A Pragmatic Randomized Controlled Trial. J Clin Med. 2024 Dec 30;14(1):161. doi: 10.3390/jcm14010161.
PubMed 39797245
Arfuch VM, Aguilar Martin C, Berenguera A, Caballol Angelats R, Goncalves AQ, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Friberg E, Pettersson E, Casajuana M. Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial. J Rehabil Med. 2023 Dec 19;55:jrm12361. doi: 10.2340/jrm.v55.12361.
PubMed 38111994

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Primary Care as a Promoter of the Quality of Life of Fibromyalgia Patients. Effectiveness and Cost-utility of a Complex Intervention Through a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04049006
Acronym / sponsor ID: PI1800943
Conditions: Fibromyalgia
Keywords: Quality of life, randomized Controlled trials, Costs and Cost analysis, Primary Health Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
Collaborators: Institut Català de la Salut, Instituto de Salud Carlos III
Study start: 1 Apr 2019 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 7 Aug 2019 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
complex-treatment benefiting group	Experimental	Other: complex treatmentParticipants in the intervention group will receive the complex treatment and the usual clinical practice.
complex-treatment no benefiting group	No intervention	–Participants in the control group will receive the care from the usual clinical practice

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Have a clinical diagnosis of fibromyalgia
Have a fixed or mobile telephone
Voluntarily accept participation in the project

Key exclusion criteria (6 listed)

Active psychotic outbreak;
Intellectual deficiency;
Severe depression and personality disorder;
Self and hetero-aggressive behaviors;
Individual assessment of active consumption of psychoactive substances;

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
complex treatmentThe complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. The sessions will be conducted in the primary health care by trained professionals.	Other	complex-treatment benefiting group

Primary outcome

Change in life quality
Time frame: change from life quality at 3, 9 and 15 months after the beginning of the study
to be evaluated with the health questionnaire (SF-36v2). It will be measured by a scale Likert: 0 (worst) to 100 (best).
Change in functional impact of fibromyalgia
Time frame: Change from functional impact of fibromyalgia at 3, 9 and 15 months after the beginning of the study.
to be evaluated with the Revised Questionnaire on the Impact of Fibromyalgia (FIQR) It will be measured by a scale Likert: 0 (best) to 100 (worst).
Change in tender points
Time frame: Change from tender points at 3, 9 and 15 months after the beginning of the study.
Tender points evaluate the presence of pain in 18 areas of the body and will be measured by a scale Likert: 0 (best) to 18 (worst).
Change in Visual Analog Scale for pain (VAS)
Time frame: Change from VAS at 3, 9 and 15 months after the beginning of the study.
The VAS evaluates the self-perceived intensity of pain by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).
Change in mood indicator (anxiety)
Time frame: Change from mood indicator (anxiety) at 3, 9 and 15 months after the beginning of the study.
To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).
Change in mood indicator (depression)
Time frame: Change from mood indicator (depression) at 3, 9 and 15 months after the beginning of the study.
To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale likert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety).

20 secondary outcomes

Sociodemographic characteristics of the patients
Time frame: baseline (pre intervention period)
Presence/absence of physical manifestations
Time frame: baseline (pre intervention period)
Presence/absence of physical or psychic trigger factor of fibromyalgia
Time frame: baseline (pre intervention period)
Presence/absence of physical, psychic or psychological factor responsible for fibromyalgia maintenance
Time frame: baseline (pre intervention period)
Presence/absence of family history of fibromyalgia
Time frame: baseline (pre intervention period)
presence/absence of cognitive psychological symptoms: Difficulty for concentration, alteration of memory
Time frame: baseline (pre intervention period)
presence/absence of comorbidities: Chronic pelvic pain, dysmenorrhoea, irritable bladder syndrome, myofascial pain
Time frame: baseline (pre intervention period)
Diagnosis date
Time frame: baseline (pre intervention period)
Years of evolution
Time frame: baseline (pre intervention period)
presence/absence of pathological history: arthrosis, arthritis and mental health problems
Time frame: baseline (pre intervention period)
Test of the thyroid stimulating hormone
Time frame: baseline (pre intervention period)
Hemogram
Time frame: baseline (pre intervention period)
Glucose, creatinine and C-reactive protein tests
Time frame: baseline (pre intervention period)
Liver Function Tests
Time frame: baseline (pre intervention period)
Globular sedimentation rate
Time frame: baseline (pre intervention period)
Rheumatoid factor
Time frame: baseline (pre intervention period)
Pharmacy billing cost
Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of visits
Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of referrals
Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention
Cost of lost productivity
Time frame: one year before the beginning of the intervention in comparison with one year after the beginning of the intervention

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 7 Sep 2023.
Results publication: PubMed 31593081Caballol Angelats R, Goncalves AQ, Aguilar Martin C, Sancho Sol MC, Gonzalez Serra G, Casajuana M, Carrasco-Querol N, Fernandez-Saez J, Dalmau Llorca MR, Abellana R, Berenguera A; SensiTEbre group. Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: A mixed methods study protocol. Medicine (Baltimore). 2019 Oct;98(41):e17289. doi: 10.1097/MD.0000000000017289.
Results publication: PubMed 33177139Arfuch VM, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Goncalves AQ, Berenguera A. Assessing the benefits on quality of life of a multicomponent intervention for fibromyalgia syndrome in primary care: patients' and health professionals' appraisals: a qualitative study protocol. BMJ Open. 2020 Nov 11;10(11):e039873. doi: 10.1136/bmjopen-2020-039873.
Results publication: PubMed 33550259Arfuch VM, Aguilar Martin C, Berenguera A, Caballol Angelats R, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Fernandez Saez J, Goncalves AQ, Casajuana M. Cost-utility analysis of a multicomponent intervention for fibromyalgia syndrome in primary care versus usual clinical practice: study protocol for an economic evaluation of a randomised control trial. BMJ Open. 2021 Feb 5;11(2):e043562. doi: 10.1136/bmjopen-2020-043562.
Results publication: PubMed 34839810Arfuch VM, Queiroga Goncalves A, Caballol Angelats R, Aguilar Martin C, Carrasco-Querol N, Sancho Sol MC, Gonzalez Serra G, Fuste Anguera I, Berenguera A. Patients' appraisals about a multicomponent intervention for fibromyalgia syndrome in primary care: a focus group study. Int J Qual Stud Health Well-being. 2021 Dec;16(1):2005760. doi: 10.1080/17482631.2021.2005760.
Results publication: PubMed 36293900Arfuch VM, Caballol Angelats R, Aguilar Martin C, Goncalves AQ, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Friberg E, Berenguera A. Patients' Lived Experience in a Multicomponent Intervention for Fibromyalgia Syndrome in Primary Care: A Qualitative Interview Study. Int J Environ Res Public Health. 2022 Oct 15;19(20):13322. doi: 10.3390/ijerph192013322.
Derived from this study: PubMed 39797245Caballol Angelats R, Goncalves AQ, Abellana R, Carrasco-Querol N, Pamies Corts A, Gonzalez Serra G, Gracia Benaiges D, Sancho Sol MC, Fuste Anguera I, Chavarria Jordana S, Cuevas Baticon B, Batlle Escolies G, Fibla Reverte M, Espuny Valles N, Buera Pitarque N, Marti Cavalle M, Suazo NP, Estivill Bargallo J, Lopez Guerrero MA, Lopez Guerrero C, Perez Acin P, Matamoros Callarisa I, Baucells J, Suazo Ciurana A, Fernandez-Saez J, Dalmau Llorca MR, Berenguera A, Aguilar Martin C. Effectiveness of a Multicomponent Program for Fibromyalgia Patients in a Primary Care Setting (FIBROCARE Program): A Pragmatic Randomized Controlled Trial. J Clin Med. 2024 Dec 30;14(1):161. doi: 10.3390/jcm14010161.
Derived from this study: PubMed 38111994Arfuch VM, Aguilar Martin C, Berenguera A, Caballol Angelats R, Goncalves AQ, Carrasco-Querol N, Gonzalez Serra G, Sancho Sol MC, Fuste Anguera I, Friberg E, Pettersson E, Casajuana M. Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial. J Rehabil Med. 2023 Dec 19;55:jrm12361. doi: 10.2340/jrm.v55.12361.
Individual participant dataSharing planned: Yes. Some individual participant data collected during the qualitative phase of the study, after deidentification, will be published in articles. Some articles were already published. Grouped (not individual) participant data that underlie the quantitative results of the trial (and also qualitative results) will be published in text, tables, or figures. The quantitative results were not yet published. Study protocols and patients' qualitative data of this project were already published.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing complex treatment in people with Fibromyalgia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site 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 6 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 7 Sep 2023. 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 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?

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?

Change in life quality (time frame: change from life quality at 3, 9 and 15 months after the beginning of the study). The study lists 6 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 NCT04049006, which also lists 7 linked publications.

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 7 Sep 2023.