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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
Sponsor:
Information provided by (Responsible Party):
Cristina Bravo, Universitat de Lleida

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Basic Body Awareness Therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Spain
Consorci Sanitari de l'Anoia
Igualada, Barcelona, Spain, 08700
Sponsors and Collaborators
Cristina Bravo
Investigators
Principal Investigator: Bravo Cristina, PT Universitat de Lleida

Publications of Results:
Responsible Party: Cristina Bravo, Principal investigator, Universitat de Lleida
ClinicalTrials.gov Identifier: NCT02830295     History of Changes
Other Study ID Numbers: University of Lleida
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Cristina Bravo, Universitat de Lleida:
body awareness therapy
physical therapy
movement therapy

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases