Fibromyalgia: Impact on Pain, Quality of Life of a Complementary Therapy on Primary Health Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Coimbra
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Quality of Life
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group
Group used as comparison.
Intervention group
Yoga practioner group with a certified teacher, 3 times a week during 3 months.
Intervention: Yoga (Other)
Outcomes
Primary Outcomes
Quality of Life
Time Frame: at the beggining and up to 3 months
EQ-5D
Pain
Time Frame: at the beggining and up to 3 months
Visual scale from 0 to 10 to measure pain
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
- 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)
Investigators
Ines Rosendo
PhD
University of Coimbra