Clinical trial NCT00961805: Effectiveness of Dance on Patients With Fibromyalgia
Official title: Effectiveness of Dance on Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Treatment
Dance
Randomized controlled study
Exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: baseline, after 16 weeks and after 32 weeks
Secondary outcomes:
measure: Function - 6 Minute Walk Test
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - Fibromyalgia Impact Questionnaire
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - SF-36 -Functional Capacity
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - SF-36 - Physical Limitation
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - Sf-36 - Pain
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - Sf-36 - General Health State
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - SF-36 - Vitality
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - SF-36 - Social Aspects
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - SF-36 - Emotional Aspects
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Quality of Life - SF-36 - Mental Health
timeFrame: baseline, after 16 weeks and after 32 weeks
measure: Depression - Beck Inventory
timeFrame: Baseline, after 16 weeks and after 32 weeks
measure: Self-image - Body Dysmorphic Disorder Examination Questionnaire
timeFrame: Baseline, after 16 weeks and after 32 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Andreia S Baptista, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Jamil Natour, MD
role: STUDY_CHAIR
References:
citation: 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.