Effectiveness of Dance on Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effectiveness of Dance on Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961805
• Other study ID #: 1044/06
• Status: Completed
• Phase: N/A
• First received: April 30, 2009
• Last updated: August 19, 2009
• Start date: August 2007
• Est. completion date: November 2008

Study information

• Verified date: August 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Dance
Belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Other:
• Control Group
The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale for Pain		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Function - 6 Minute Walk Test		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - Fibromyalgia Impact Questionnaire		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - SF-36 -Functional Capacity		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - SF-36 - Physical Limitation		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - Sf-36 - Pain		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - Sf-36 - General Health State		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - SF-36 - Vitality		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - SF-36 - Social Aspects		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - SF-36 - Emotional Aspects		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Quality of Life - SF-36 - Mental Health		baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Depression - Beck Inventory		Baseline, after 16 weeks and after 32 weeks	Yes
Secondary	Self-image - Body Dysmorphic Disorder Examination Questionnaire		Baseline, after 16 weeks and after 32 weeks	Yes