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NCT04049006
Effectiveness and Cost-utility of a Complex Intervention for Fibromyalgia Patients
NA trial testing complex treatment in Fibromyalgia in 302 participants. Completed in 31 March 2021.
31 March 2021
Quick facts
| Lead sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 302 |
| Start date | 1 April 2019 |
| Primary completion | 31 March 2021 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- complex treatment
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina — full company profile →
Who can join
Eligibility, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Caballol Angelats R, Gonçalves AQ, Aguilar Martín C, Sancho Sol MC, et al · · 2019 · cited 15× · PMID 31593081 · DOI 10.1097/md.0000000000017289 -
Patients' Lived Experience in a Multicomponent Intervention for Fibromyalgia Syndrome in Primary Care: A Qualitative Interview Study.
Arfuch VM, Caballol Angelats R, Aguilar Martín C, Gonçalves AQ, et al · · 2022 · cited 10× · PMID 36293900 · DOI 10.3390/ijerph192013322 -
Patients' appraisals about a multicomponent intervention for fibromyalgia syndrome in primary care: a focus group study.
Arfuch VM, Queiroga Gonçalves A, Caballol Angelats R, Aguilar Martín C, et al · · 2021 · cited 8× · PMID 34839810 · DOI 10.1080/17482631.2021.2005760 -
Effectiveness of a Multicomponent Program for Fibromyalgia Patients in a Primary Care Setting (FIBROCARE Program): A Pragmatic Randomized Controlled Trial.
Caballol Angelats R, Gonçalves AQ, Abellana R, Carrasco-Querol N, et al · · 2024 · cited 4× · PMID 39797245 · DOI 10.3390/jcm14010161 -
Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial.
Arfuch VM, Aguilar Martín C, Berenguera A, Caballol Angelats R, et al · · 2023 · cited 4× · PMID 38111994 · DOI 10.2340/jrm.v55.12361 -
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.
Arfuch VM, Caballol Angelats R, Aguilar Martín C, Carrasco-Querol N, et al · · 2020 · cited 4× · PMID 33177139 · DOI 10.1136/bmjopen-2020-039873 -
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.
Arfuch VM, Aguilar Martín C, Berenguera A, Caballol Angelats R, et al · · 2021 · cited 3× · PMID 33550259 · DOI 10.1136/bmjopen-2020-043562 -
Usefulness of a Multicomponent Group Intervention Program for Fibromyalgia Patients in Primary Care: A Qualitative Study of Health Professionals.
Caballol Angelats R, Aguilar Martín C, Carrasco-Querol N, Abellana R, et al · · 2023 · cited 1× · PMID 38200923 · DOI 10.3390/healthcare12010017
Verify or expand the search:
- PubMed search for NCT04049006
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04049006 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Last refreshed: 7 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04049006.
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