Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Other: Basic Body Awareness Therapy
- Registration Number
- NCT02830295
- Lead Sponsor
- Cristina Bravo
- Brief Summary
A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of treatment as an usual. Sessions of BBAT lasted 90 minutes each and took place twice a week for 5 weeks. The primary end point is a change in the Visual Analog Scale score and Body Awareness Rating Scale and the secondary end points include Hospital Anxiety Depression, State Trait Anxiety Inventory, Beck Depression Inventory and Short Form 36. All assessments will be repeated at post treatment, 12 weeks and 24 weeks
- Detailed Description
This work is a clinical trial of randomised and controlled groups. The hypothesis of study is that Basic Body Awareness Therapy applied in patients with fibromyalgia improves, more than usual treatment, the pain, normalization of postural pattern and movement, improve in psychologic state and improve of quality life.
The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in area of primary health center, the patients will be divided in 2 groups, control group and treatment group. The groups will be examined at the begin, at 1 month of the begin of treatment, in 3 months, 6 months and one year to evaluated the outcomes in long time.
The dependence measurements will be Visual Analog Scale, Basic Body Awareness Rating Scale (BARS), SF-36, STAI A/R, BDI-II. The independence measurements will be demographic items: sex, age, country, level of studies, social status,..
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- patients diagnosed of fibromyalgia according the American college of Rheumatology with 6 months at least
- the patients have to stay in different position as lying, sitting and standing
- pregnancy
- suffering from another diseases that increase the pain or another specific diagnosis as rheumatic, heart disease and infectious disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Basic Body Awareness Therapy Basic Body Awareness Therapy The Basic Body Awareness Therapy is usual therapy of physiotherapy in health mental in nord of europe. BBAT is based in twelve movements and massage that improve the movement quality of patient, also BBAT improves others movement qualities like biomechanical, physiologic, socio-cultural and existential.
- Primary Outcome Measures
Name Time Method Visual Analog Scale up to 24 weeks This scale evaluates the pain refered by patient with a scale from 0 to 10 being 10 the maximum pain
- Secondary Outcome Measures
Name Time Method State Trait Anxiety Inventory up to 24 weeks this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety
Hospital Anxiety Depression up to 24 weeks this scale evaluates the level of depression and anxiety with a questionary that score goes from 0 to 21, being 21 the maximum level of disease
Short Form 36 up to 24 weeks this questionary evaluates the quality of life in different components. The score goes from 0 to 100 being 100 the best score for quality of life
Beck Depression Inventory up to 24 weeks this scale evaluates the level of depression with a questionary that scores from 0 to 63, being 63 the maximum level of depression
Trial Locations
- Locations (1)
Consorci Sanitari de l'Anoia
🇪🇸Igualada, Barcelona, Spain