NCT02830295

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

June 11, 2016

Last Update Submit

May 8, 2017

Conditions

Keywords

body awareness therapyphysical therapymovement therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hospital Anxiety Depression

    up to 24 weeks

  • Beck Depression Inventory

    up to 24 weeks

  • State Trait Anxiety Inventory

    up to 24 weeks

  • Short Form 36

    up to 24 weeks

Study Arms (2)

Basic Body Awareness Therapy

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

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

Also known as: BBAT (acronym)
Basic Body Awareness Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • suffering from another diseases that increase the pain or another specific diagnosis as rheumatic, heart disease and infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de l'Anoia

Igualada, Barcelona, 08700, Spain

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Bravo Cristina, PT

    Universitat de Lleida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 11, 2016

First Posted

July 12, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations