Effectiveness of a Rehabilitation Programme Based on Lifestyle Changes and Self-care in Patients Diagnosed With Fibromyalgia: Neuroinflammatory and Neuropsychological Biomarkers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 4
- Primary Endpoint
- Serotonin
Study Overview
Brief Summary
A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of stretching. Sessions of BBAT lasted 90 min each and took place twice a week form 12 weeks. The primary end point is a change in the biomarkers and neurotransmitters and the Fibromyalgia Impact Questionnaire and the secondary end points include Visual Analog Scale, State Trait Anxiety inventory, Beck Depression Inventory. All assessments will be repeated at post treatment, 12 and 24 weeks and 1 year follow-up.
Detailed Description
This work is a clinical trial of randomized and controlled groups. The hypothesis of study is that BBAT applied in patients with fibromyalgia improves, more than stretching exercises, the pain, normalization biomarkers, improve in psychological state and quality life.
The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in Consorci Sociosanitari of Anoia, the patients will be divided in 2 groups, control and treatment group. The groups will be examined at the begin, at 2 weeks, at the end of treatment and 3, 6 and 12 months follow-up.
The dependence measurements will be biomarkers serotonin, dopamine and cortisol, also Visual Analog Scale, State Trait Anxiety Inventory (STAI A/R), Beck Depression Inventory (BDI-II) and Fibromyalgia Impact Questionnaire (FIQ). The independence measurements will be demographic items: sex, age, country, level of studies, social status...
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
the patients don't know what intervention of study. Investigator don't know the allocation of patients outcomes assessor don't know the allocation of patients.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •whose diagnosed of fibromyalgia almost 6 months before
- •whose could be in different position such as lying, sitting, and stand-up
Exclusion Criteria
- •whose are diagnosed of disease that it worse the pain
- •pregnancy
- •whose are diagnosed of other disease such as rheumatology, neurology, cardiac problems o another internal medical condition,malignant disease or acute infections
Outcomes
Primary Outcomes
Serotonin
Time Frame: through study completion, an average of 1 year
Neurotransmitter neurologic
cortisol
Time Frame: during the procedure
acute hormone relating stress
Secondary Outcomes
- State Trait Anxiety Inventory (STAI)(through study completion, an average of 1 year)
- Visual Analog Scale (VAS)(through study completion, an average of 1 year)
- Fibromyalgia Impact Questionnaire (FIQ)(through study completion, an average of 1 year)
- Beck Depression Inventory- II (BDI-II)(through study completion, an average of 1 year)
Investigators
Cristina Bravo
Postdoctoral Researcher
Universitat de Lleida