Yoga Impact in Fibromyalgia, Primary Health Care

NCT06646796 | Not Yet Recruiting

• 1 other identifier: 067/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Chronic pain; Yoga; Complementary and alternative medicine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Well-being

  at the beggining and up to 3 months

• Benefits perceived

  up to 3 months

• Difficulties perceived

  up to 3 months

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

  up to 3 months

Study Arms (2)

Control group

NO INTERVENTION

Group used as comparison.

Intervention group

EXPERIMENTAL

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

Other: Yoga

Interventions

Yoga OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• people under 18 years old.

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

USF Coimbra Centro

Coimbra, Coimbra District, 3000-174, Portugal

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Inês Rosendo Silva, MD PhD

CONTACT

(351) 918-4186; inesrcs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: October 17, 2024
• Study Start: December 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 30, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)