Clinical trial NCT06646796: Yoga Impact in Fibromyalgia, Primary Health Care
Official title: Fibromyalgia: Impact on Pain, Quality of Life of a Complementary Therapy on Primary Health Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Chronic pain
Yoga
Complementary and alternative medicine
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Quality of Life
timeFrame: at the beggining and up to 3 months
measure: Pain
timeFrame: at the beggining and up to 3 months
measure: Global perception of change
timeFrame: up to 3 months
Secondary outcomes:
measure: Well-being
timeFrame: at the beggining and up to 3 months
measure: Benefits perceived
timeFrame: up to 3 months
measure: Difficulties perceived
timeFrame: up to 3 months
measure: Replicability and ease of introducing treatment in the context of the Portuguese national health service
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: USF Coimbra Centro
Study officials:
References:
citation: 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.
citation: 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.