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Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia (BBAT)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Basic Body Awareness Therapy
Sponsored by
Cristina Bravo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring body awareness therapy, physical therapy, movement therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Consorci Sanitari de l'Anoia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Basic Body Awareness Therapy

control

Arm Description

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.

the patients which below receive the treatment as usual, according the clinic guidelines of Health government

Outcomes

Primary Outcome Measures

Visual Analog Scale
This scale evaluates the pain refered by patient with a scale from 0 to 10 being 10 the maximum pain

Secondary Outcome Measures

Hospital Anxiety Depression
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
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
this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety
Short Form 36
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

Full Information

First Posted
June 11, 2016
Last Updated
May 8, 2017
Sponsor
Cristina Bravo
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1. Study Identification

Unique Protocol Identification Number
NCT02830295
Brief Title
Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia
Acronym
BBAT
Official Title
Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristina Bravo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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,..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
body awareness therapy, physical therapy, movement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic Body Awareness Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
the patients which below receive the treatment as usual, according the clinic guidelines of Health government
Intervention Type
Other
Intervention Name(s)
Basic Body Awareness Therapy
Other Intervention Name(s)
BBAT (acronym)
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
This scale evaluates the pain refered by patient with a scale from 0 to 10 being 10 the maximum pain
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety Depression
Description
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
Time Frame
up to 24 weeks
Title
Beck Depression Inventory
Description
this scale evaluates the level of depression with a questionary that scores from 0 to 63, being 63 the maximum level of depression
Time Frame
up to 24 weeks
Title
State Trait Anxiety Inventory
Description
this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety
Time Frame
up to 24 weeks
Title
Short Form 36
Description
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
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bravo Cristina, PT
Organizational Affiliation
Universitat de Lleida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consorci Sanitari de l'Anoia
City
Igualada
State/Province
Barcelona
ZIP/Postal Code
08700
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16012065
Citation
Gard G. Body awareness therapy for patients with fibromyalgia and chronic pain. Disabil Rehabil. 2005 Jun 17;27(12):725-8. doi: 10.1080/09638280400009071.
Results Reference
result
PubMed Identifier
25603742
Citation
Courtois I, Cools F, Calsius J. Effectiveness of body awareness interventions in fibromyalgia and chronic fatigue syndrome: a systematic review and meta-analysis. J Bodyw Mov Ther. 2015 Jan;19(1):35-56. doi: 10.1016/j.jbmt.2014.04.003. Epub 2014 Apr 18.
Results Reference
result
PubMed Identifier
21810264
Citation
Jones KD, King LA, Mist SD, Bennett RM, Horak FB. Postural control deficits in people with fibromyalgia: a pilot study. Arthritis Res Ther. 2011 Aug 2;13(4):R127. doi: 10.1186/ar3432.
Results Reference
result

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Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia

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