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

Fibromyalgia Clinical Trial

— BBAT  

Official title:

Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830295
• Other study ID #: University of Lleida
• Status: Completed
• Phase: N/A
• First received: June 11, 2016
• Last updated: May 8, 2017
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Universitat de Lleida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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,..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Spain	Consorci Sanitari de l'Anoia	Igualada	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Cristina Bravo

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. R — View Citation

Gard G. Body awareness therapy for patients with fibromyalgia and chronic pain. Disabil Rehabil. 2005 Jun 17;27(12):725-8. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	This scale evaluates the pain refered by patient with a scale from 0 to 10 being 10 the maximum pain	up to 24 weeks
Secondary	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	up to 24 weeks
Secondary	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	up to 24 weeks
Secondary	State Trait Anxiety Inventory	this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety	up to 24 weeks
Secondary	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	up to 24 weeks