University of Lleida
Cristina Bravo
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.
Fibromyalgia
Basic Body Awareness Therapy
Stretching Exercise
Not Applicable
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 Type : | Interventional |
| Estimated Enrollment : | 110 participants |
| Masking : | Triple |
| 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. |
| Primary Purpose : | Treatment |
| Official Title : | Biomarkers Changes in Patients With Fibromyalgia Using Basic Body Awareness Therapy |
| Actual Study Start Date : | February 1, 2023 |
| Estimated Primary Completion Date : | February 1, 2024 |
| Estimated Study Completion Date : | February 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Basic Body Awareness Therapy the Basic Body Awareness Therapy is usual therapy of physiotherapy in mental health in nord europe. BBAT is based in twelve movements and massage that improve the movements quality of patient, also improves other movement qualities like biomechanical, physiologic, socio-cultural and existential |
Other: Basic Body Awareness Therapy |
|
Active Comparator: Stretching group Stretching exercise will be developed in control group in order to blind the intervention of interest. It will consist in analytic stretching of trunk, upper and lower limb. It will last around 45 min twice a week during 12 weeks. |
Other: Stretching Exercise |
| Ages Eligible for Study: | 18 Years to 65 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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