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Clinical Trials/NCT00961805
NCT00961805CompletedNot Applicable

Effectiveness of Dance on Patients With Fibromyalgia

Federal University of São Paulo2 sites in 1 country80 target enrollmentStarted: August 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
Visual Analog Scale for Pain

Study Overview

Brief Summary

The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • classification of fibromyalgia based on the criteria of the American College of Rheumatology
  • female gender
  • aged between 18 and 65 years

Exclusion Criteria

  • not having altered treatment in previous three years
  • having signed a term of informed consent
  • patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded

Outcomes

Primary Outcomes

Visual Analog Scale for Pain

Time Frame: baseline, after 16 weeks and after 32 weeks

score between 0 and 100 where 0 is no pain and 100 in unbearable pain

Secondary Outcomes

  • Function - 6 Minute Walk Test(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - Fibromyalgia Impact Questionnaire(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - SF-36 -Functional Capacity(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - SF-36 - Physical Limitation(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - Sf-36 - Pain(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - Sf-36 - General Health State(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - SF-36 - Vitality(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - SF-36 - Social Aspects(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - SF-36 - Emotional Aspects(baseline, after 16 weeks and after 32 weeks)
  • Quality of Life - SF-36 - Mental Health(baseline, after 16 weeks and after 32 weeks)
  • Depression - Beck Inventory(Baseline, after 16 weeks and after 32 weeks)
  • Self-image - Body Dysmorphic Disorder Examination Questionnaire(Baseline, after 16 weeks and after 32 weeks)

Investigators

Sponsor
Federal University of São Paulo
Sponsor Class
Other

Study Sites (2)

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