FibromyalgiaNCT06646796
Yoga Impact in Fibromyalgia, Primary Health Care
A study testing Yoga in people with Fibromyalgia, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- people under 18 years old.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
USF Coimbra Centro
Coimbra, Coimbra District, 3000-174
Inês R Silva, MD PhD, +351918418663, inesrcs@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Yoga
- Keywords
- Fibromyalgia, Chronic pain, Yoga, Complementary and alternative medicine
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Yoga with certified teacher, 3 times a week during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
EQ-5D
Measured: at the beggining and up to 3 months
Pain
Visual scale from 0 to 10 to measure pain
Measured: 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)
Measured: up to 3 months
Secondary outcomes (4)
Well-being
EADS-21
Measured: at the beggining and up to 3 months
Benefits perceived
Open question answered by the patients trough a written text
Measured: up to 3 months
Difficulties perceived
Open question answered by the patients trough a written text
Measured: up to 3 months
Replicability and ease of introducing treatment in the context of the Portuguese national health service
Open questions and SWOT analysis
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Rosendo, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646796
- Sponsor's protocol ID
- 067/2024
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28734619Prabhakar 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.
PubMed 30830504
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia: Impact on Pain, Quality of Life of a Complementary Therapy on Primary Health Care
- ClinicalTrials.gov ID
- NCT06646796
- Acronym / sponsor ID
- 067/2024
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Chronic pain, Yoga, Complementary and alternative medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Group used as comparison. |
| Intervention group | Experimental | Other: YogaYoga practioner group with a certified teacher, 3 times a week during 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- people under 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga with certified teacher, 3 times a week during 3 months. | Other | Intervention group |
Primary outcome
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)
4 secondary outcomes
Well-being
Time frame: at the beggining and up to 3 months
Benefits perceived
Time frame: up to 3 months
Difficulties perceived
Time frame: up to 3 months
Replicability and ease of introducing treatment in the context of the Portuguese national health service
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 28734619Cabo-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.
- Background: PubMed 30830504Prabhakar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Fibromyalgia, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inês Rosendo Silva, MD PhD ((351) 918-4186, inesrcs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: at the beggining and up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06646796, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.