Clinical trial NCT02830295: Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia
Official title: Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: body awareness therapy
physical therapy
movement therapy
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,..

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Hospital Anxiety Depression
timeFrame: up to 24 weeks
measure: Beck Depression Inventory
timeFrame: up to 24 weeks
measure: State Trait Anxiety Inventory
timeFrame: up to 24 weeks
measure: Short Form 36
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Igualada
country: Spain
facility: Consorci Sanitari de l'Anoia
state: Barcelona
Study officials:
affiliation: Universitat de Lleida
name: Bravo Cristina, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.