Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia (BBAT)
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|ClinicalTrials.gov Identifier: NCT02830295|
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Basic Body Awareness Therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||December 2016|
Experimental: 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.
Other: Basic Body Awareness Therapy
Basic body awareness therapy is a health oriented and person-centred approach with focus on the patient's resources. This is a method in physiotherapy, where we search to promote movement quality in daily life through self-exploration and self-experience.BBAT conceives the person from the biomechanical, physiological, bio-psycho-social and existential aspects, using the movement quality as a witness of the link in between all these perspectives.It can be done individually or in groups, through different daily life movements: lying, sitting, standing, walking, pair movements, use of voice and massages. BBAT has validated and reliable assesment tools, as BARS and BAS-I
Other Name: BBAT (acronym)
No Intervention: control
the patients which below receive the treatment as usual, according the clinic guidelines of Health government
- 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
- Hospital Anxiety Depression [ Time Frame: 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
- Beck Depression Inventory [ Time Frame: 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
- State Trait Anxiety Inventory [ Time Frame: up to 24 weeks ]this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety
- Short Form 36 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830295
|Consorci Sanitari de l'Anoia|
|Igualada, Barcelona, Spain, 08700|
|Principal Investigator:||Bravo Cristina, PT||Universitat de Lleida|