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Not yet recruiting NCT06646796

Yoga Impact in Fibromyalgia, Primary Health Care

No phase Interventional Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yoga.
Who it may be relevant to
Registry conditions: Fibromyalgia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Fibromyalgia: Impact on Pain, Quality of Life of a Complementary Therapy on Primary Health Care

Overview

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

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.

Interventions

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

Primary outcome measures

  • Quality of Life [Time frame: at the beggining and up to 3 months]
  • Pain [Time frame: at the beggining and up to 3 months]
  • Global perception of change [Time frame: up to 3 months]
Secondary outcome measures (4)
  • Well-being [Time frame: at the beggining and up to 3 months]
  • Benefits perceived [Time frame: up to 3 months]
  • Difficulties perceived [Time frame: up to 3 months]
  • Replicability and ease of introducing treatment in the context of the Portuguese national health service [Time frame: up to 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Portugal · 1 center
  • USF Coimbra Centro — Coimbra

Publications

  • 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. PMID 28734619
  • 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. PMID 30830504

Identifiers

NCT: NCT06646796 · 067/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗