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NCT Number: NCT06646796

Yoga Impact in Fibromyalgia, Primary Health Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

yoga

Other

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

Primary outcomes

  1. Quality of Life

    Time frame: at the beggining and up to 3 months

    EQ-5D

  2. Pain

    Time frame: at the beggining and up to 3 months

    Visual scale from 0 to 10 to measure pain

  3. Global perception of change

    Time frame: up to 3 months

    Patient Global Impression of Change scale (portuguese validated version)

    1 to 7 (1 is the worst, 7 is the best)

Secondary outcomes

  1. Well-being

    Time frame: at the beggining and up to 3 months

    EADS-21

  2. Benefits perceived

    Time frame: up to 3 months

    Open question answered by the patients trough a written text

  3. Difficulties perceived

    Time frame: up to 3 months

    Open question answered by the patients trough a written text

  4. Replicability and ease of introducing treatment in the context of the Portuguese national health service

    Time frame: up to 3 months

    Open questions and SWOT analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Inês Rosendo Silva, MD PhD

CONTACT

[email protected]

(351) 918-4186

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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