Yoga Impact in Fibromyalgia, Primary Health Care

NCT ID: NCT06646796

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-04-30

Brief Summary

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This study aims to evaluate the effectiveness of a complementary therapy using Yoga within the scope of First Health Care in Portugal, in pain control, quality of life and well-being of the patients with Fibromyalgia. It also, pretends to assess the viability and to identify the barriers to this sort of therapy in the context of Primary Health Care.

Detailed Description

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Fibromyalgia is a chronic and debilitating pain syndrome characterized by widespread and persistent pain, also affecting sleep quality and cognitive function. It is estimated to affect 3.6% of the population; however, since it is a condition that is often underdiagnosed, the actual numbers may be higher. It is also an incurable disease, so treatment is based on symptom management through pharmacological therapy, which is not always effective. Due to the inadequacy of pharmacological therapy, there is a need for complementary therapies, and despite the limited number of studies conducted in this area, some therapies based on meditative movement (notably yoga) are beginning to emerge, with beneficial effects reported on pain management and quality of life in these patients. Therefore, this study aims to investigate the benefits and feasibility of this type of intervention at the Primary Health Care level.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In the first phase, the questionnaire will be validated with all patients of the Family Health Unit diagnosed with fibromyalgia who agree to participate. Subsequently, all participants will be asked if they wish to participate in the intervention study, and those who agree will be randomized into either the intervention or control group. The intervention group will engage in Yoga practice with a certified yoga instructor, three times a week for three months. Quality of life scales, a well-being scale, and pain measurement on a numerical scale from 0 to 10 will be applied before and after the intervention, complemented by an open-ended question for qualitative analysis regarding perceived benefits and difficulties.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Group used as comparison.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Yoga practioner group with a certified teacher, 3 times a week during 3 months.

Group Type EXPERIMENTAL

Yoga

Intervention Type OTHER

Yoga with certified teacher, 3 times a week during 3 months.

Interventions

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Yoga

Yoga with certified teacher, 3 times a week during 3 months.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Users of the Family Health Unit diagnosed with Fibromyalgia;
* With cognitive capacity to answer the questionnaire;
* With physical capacity to take part in Yoga classes.

Exclusion Criteria

* people under 18 years old.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Coimbra

OTHER

Sponsor Role lead

Responsible Party

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Ines Rosendo

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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USF Coimbra Centro

Coimbra, Coimbra District, Portugal

Site Status

Countries

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Portugal

Central Contacts

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Inês Rosendo Silva, MD PhD

Role: CONTACT

(351) 918-4186

Facility Contacts

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Inês R Silva, MD PhD

Role: primary

+351918418663

References

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Cabo-Meseguer A, Cerda-Olmedo G, Trillo-Mata JL. Fibromyalgia: Prevalence, epidemiologic profiles and economic costs. Med Clin (Barc). 2017 Nov 22;149(10):441-448. doi: 10.1016/j.medcli.2017.06.008. Epub 2017 Jul 19. English, Spanish.

Reference Type BACKGROUND
PMID: 28734619 (View on PubMed)

Prabhakar A, Kaiser JM, Novitch MB, Cornett EM, Urman RD, Kaye AD. The Role of Complementary and Alternative Medicine Treatments in Fibromyalgia: a Comprehensive Review. Curr Rheumatol Rep. 2019 Mar 4;21(5):14. doi: 10.1007/s11926-019-0814-0.

Reference Type BACKGROUND
PMID: 30830504 (View on PubMed)

Other Identifiers

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067/2024

Identifier Type: -

Identifier Source: org_study_id

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