Yoga Impact in Fibromyalgia, Primary Health Care

Fibromyalgia: Impact on Pain, Quality of Life of a Complementary Therapy on 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Yoga

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inês Rosendo Silva, MD PhD; Phone Number: (351) 918-4186; Email: inesrcs@gmail.com

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-174
    • USF Coimbra Centro
    • Contact: Inês R Silva, MD PhD; Phone Number: +351918418663; Email: inesrcs@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Group used as comparison.
Experimental: Intervention group; Yoga practioner group with a certified teacher, 3 times a week during 3 months.	Other: Yoga; Yoga with certified teacher, 3 times a week during 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	EQ-5D	at the beggining and up to 3 months
Pain	Visual scale from 0 to 10 to measure pain	at the beggining and up to 3 months
Global perception of change	Patient Global Impression of Change scale (portuguese validated version) 1 to 7 (1 is the worst, 7 is the best)	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	EADS-21	at the beggining and up to 3 months
Benefits perceived	Open question answered by the patients trough a written text	up to 3 months
Difficulties perceived	Open question answered by the patients trough a written text	up to 3 months
Replicability and ease of introducing treatment in the context of the Portuguese national health service	Open questions and SWOT analysis	up to 3 months

Collaborators and Investigators

• Sponsor: University of Coimbra

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Yoga; Chronic pain; Fibromyalgia; Complementary and alternative medicine
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 067/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No