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Completed

NCT Number: NCT02830295

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

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari de l'Anoia

Igualada, Barcelona, 08700, Spain

About this study

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,..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basic Body Awareness Therapy

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

Other names: BBAT (acronym)

Primary outcomes

  1. Visual Analog Scale

    Time frame: up to 24 weeks

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

Secondary outcomes

  1. Hospital Anxiety Depression

    Time frame: up to 24 weeks

    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

  2. Beck Depression Inventory

    Time frame: up to 24 weeks

    this scale evaluates the level of depression with a questionary that scores from 0 to 63, being 63 the maximum level of depression

  3. State Trait Anxiety Inventory

    Time frame: up to 24 weeks

    this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety

  4. Short Form 36

    Time frame: up to 24 weeks

    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

Sponsors and collaborators

Lead sponsor

Cristina Bravo

Other

Registry information

Official study title

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

Acronym: BBAT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 12, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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