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Clinical Trials/NCT02830295
NCT02830295
Completed
Not Applicable

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

Cristina Bravo1 site in 1 country40 target enrollmentJuly 2016
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Cristina Bravo
Enrollment
40
Locations
1
Primary Endpoint
Visual Analog Scale
Status
Completed
Last Updated
8 years ago

Overview

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,..

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cristina Bravo
Responsible Party
Sponsor Investigator
Principal Investigator

Cristina Bravo

Principal investigator

Universitat de Lleida

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

Outcomes

Primary Outcomes

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

  • State Trait Anxiety Inventory(up to 24 weeks)
  • Hospital Anxiety Depression(up to 24 weeks)
  • Short Form 36(up to 24 weeks)
  • Beck Depression Inventory(up to 24 weeks)

Study Sites (1)

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