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

NCT ID: NCT02830295

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-12-31

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,..

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Basic Body Awareness Therapy

Intervention Type: OTHER

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

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

BBAT (acronym)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cristina Bravo

OTHER

Sponsor Role: lead

Responsible Party

Cristina Bravo

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bravo Cristina, PT

Role: PRINCIPAL_INVESTIGATOR

Universitat de Lleida

Locations

Consorci Sanitari de l'Anoia

Igualada, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 16012065 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25603742 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21810264 (View on PubMed)

Other Identifiers

University of Lleida

Identifier Type: -

Identifier Source: org_study_id