Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Visual Analog Scale
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 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,..
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •pregnancy
- •suffering from another diseases that increase the pain or another specific diagnosis as rheumatic, heart disease and infectious disease
Outcomes
Primary Outcomes
Visual Analog Scale
Time Frame: 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 Outcomes
- State Trait Anxiety Inventory(up to 24 weeks)
- Hospital Anxiety Depression(up to 24 weeks)
- Short Form 36(up to 24 weeks)
- Beck Depression Inventory(up to 24 weeks)
Investigators
Cristina Bravo
Principal investigator
Universitat de Lleida