Effectiveness of Dance on Patients With Fibromyalgia

• ClinicalTrials.gov Identifier: NCT00961805
• Recruitment Status: Completed
• First Posted: August 19, 2009
• Results First Posted: August 19, 2009
• Last Update Posted: August 25, 2009
• Sponsor: Federal University of São Paulo
• Information provided by: Federal University of São Paulo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Behavioral: Dance; Other: Control Group	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Dance on Patients With Fibromyalgia
• Study Start Date: August 2007
• Actual Primary Completion Date: September 2007
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dance Group; Belly dance	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.
No Intervention: Control Group; Waiting list	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).

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Function - 6 Minute Walk Test [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   meters traveled on a 20-meter course over a six-minute period
2. Quality of Life - Fibromyalgia Impact Questionnaire [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment
3. Quality of Life - SF-36 -Functional Capacity [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 100, with higher scores denoting better quality of life
4. Quality of Life - SF-36 - Physical Limitation [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 100, with higher scores denoting better quality of life
5. Quality of Life - Sf-36 - Pain [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 100, with higher scores denoting better quality of life
6. Quality of Life - Sf-36 - General Health State [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 100, with higher scores denoting better quality of life
7. Quality of Life - SF-36 - Vitality [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 100, with higher scores denoting better quality of life
8. Quality of Life - SF-36 - Social Aspects [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 100, with higher scores denoting better quality of life
9. Quality of Life - SF-36 - Emotional Aspects [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
   score between 0 from 100, with higher scores denoting better quality of life
10. Quality of Life - SF-36 - Mental Health [ Time Frame: baseline, after 16 weeks and after 32 weeks ]
    score between 0 from 100, with higher scores denoting better quality of life
11. Depression - Beck Inventory [ Time Frame: Baseline, after 16 weeks and after 32 weeks ]
    score between 0 from 63, with higher score indicating greater depression
12. Self-image - Body Dysmorphic Disorder Examination Questionnaire [ Time Frame: Baseline, after 16 weeks and after 32 weeks ]
    scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Brazil

Federal University of Sao Paulo

Sao Paulo, SP, Brazil, 04023-090

Sponsors and Collaborators

Federal University of São Paulo

Investigators

• Principal Investigator: Andreia S Baptista, PT; Federal University of Sao Paulo
• Study Chair: Jamil Natour, MD; Federal University of Sao Paulo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baptista AS, Villela AL, Jones A, Natour J. Effectiveness of dance in patients with fibromyalgia: a randomized, single-blind, controlled study. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):18-23. Epub 2012 Dec 14.

• Responsible Party: Andreia Salvador Baptista, Federal Unversity of Sao Paulo
• ClinicalTrials.gov Identifier: NCT00961805
• Other Study ID Numbers: 1044/06
• First Posted: August 19, 2009
• Results First Posted: August 19, 2009
• Last Update Posted: August 25, 2009
• Last Verified: August 2009

Keywords provided by Federal University of São Paulo:

Fibromyalgia; Treatment; Dance; Randomized controlled study; Exercise

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases