Fibromyalgia
Conditions
Keywords
Fibromyalgia, Treatment, Dance, Randomized controlled study, Exercise
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.
Interventions
BEHAVIORALDance
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.
OTHERControl 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).
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Pain | baseline, after 16 weeks and after 32 weeks | score between 0 and 100 where 0 is no pain and 100 in unbearable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - Fibromyalgia Impact Questionnaire | baseline, after 16 weeks and after 32 weeks | score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment |
| Quality of Life - SF-36 -Functional Capacity | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
| Quality of Life - SF-36 - Physical Limitation | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
| Quality of Life - Sf-36 - Pain | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
| Quality of Life - Sf-36 - General Health State | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
| Function - 6 Minute Walk Test | baseline, after 16 weeks and after 32 weeks | meters traveled on a 20-meter course over a six-minute period |
| Quality of Life - SF-36 - Social Aspects | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
| Quality of Life - SF-36 - Emotional Aspects | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
| Quality of Life - SF-36 - Mental Health | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
| Depression - Beck Inventory | Baseline, after 16 weeks and after 32 weeks | score between 0 from 63, with higher score indicating greater depression |
| Self-image - Body Dysmorphic Disorder Examination Questionnaire | Baseline, after 16 weeks and after 32 weeks | scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image |
| Quality of Life - SF-36 - Vitality | baseline, after 16 weeks and after 32 weeks | score between 0 from 100, with higher scores denoting better quality of life |
Countries
Brazil
Participant flow
Recruitment details
The recruitment of patients started in August 2007 and finished in April 2008. The recruitment was made in Sao Paulo Hospital division of Rheumatology
Participants by arm
| Arm | Count |
|---|---|
| Group Control The waiting list | 40 |
| Dance Group The participants in the dance group took one-hour 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 | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Dance Group | Group Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age Continuous | 49.5 years STANDARD_DEVIATION 10.9 | 49.1 years STANDARD_DEVIATION 11.5 | 49.3 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Brazil | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Outcome results
Primary
Visual Analog Scale for Pain
score between 0 and 100 where 0 is no pain and 100 in unbearable pain
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Visual Analog Scale for Pain | Baseline | 75 mm | Standard Deviation 13 |
| Control Group | Visual Analog Scale for Pain | After 16 weeks | 75 mm | Standard Deviation 14 |
| Control Group | Visual Analog Scale for Pain | After 32 weeks | 73 mm | Standard Deviation 17 |
| Dance Group | Visual Analog Scale for Pain | Baseline | 75 mm | Standard Deviation 17 |
| Dance Group | Visual Analog Scale for Pain | After 16 weeks | 46 mm | Standard Deviation 20 |
| Dance Group | Visual Analog Scale for Pain | After 32 weeks | 47 mm | Standard Deviation 26 |
Comparison: Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.~Analysis was intention to treat using the LOCF technique.p-value: <0.001ANOVA
Secondary
Depression - Beck Inventory
score between 0 from 63, with higher score indicating greater depression
Time frame: Baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Depression - Beck Inventory | Baseline | 21.2 units on a scale | Standard Deviation 13 |
| Control Group | Depression - Beck Inventory | After 16 weeks | 23.5 units on a scale | Standard Deviation 11.5 |
| Control Group | Depression - Beck Inventory | After 32 weeks | 23.5 units on a scale | Standard Deviation 13.7 |
| Dance Group | Depression - Beck Inventory | Baseline | 23.9 units on a scale | Standard Deviation 14.7 |
| Dance Group | Depression - Beck Inventory | After 16 weeks | 20.2 units on a scale | Standard Deviation 13.2 |
| Dance Group | Depression - Beck Inventory | After 32 weeks | 23.1 units on a scale | Standard Deviation 15.3 |
p-value: 0.136ANOVA
Secondary
Function - 6 Minute Walk Test
meters traveled on a 20-meter course over a six-minute period
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Function - 6 Minute Walk Test | Baseline | 332 meters | Standard Deviation 66.7 |
| Control Group | Function - 6 Minute Walk Test | after 16 weeks | 344.3 meters | Standard Deviation 72.7 |
| Control Group | Function - 6 Minute Walk Test | after 32 weeks | 343 meters | Standard Deviation 77.9 |
| Dance Group | Function - 6 Minute Walk Test | Baseline | 372.8 meters | Standard Deviation 80.2 |
| Dance Group | Function - 6 Minute Walk Test | after 16 weeks | 443.5 meters | Standard Deviation 78.3 |
| Dance Group | Function - 6 Minute Walk Test | after 32 weeks | 431 meters | Standard Deviation 88.7 |
p-value: <0.001ANOVA
Secondary
Quality of Life - Fibromyalgia Impact Questionnaire
score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - Fibromyalgia Impact Questionnaire | Baseline | 6.34 units on a scale | Standard Deviation 1.29 |
| Control Group | Quality of Life - Fibromyalgia Impact Questionnaire | After 16 weeks | 6.61 units on a scale | Standard Deviation 1.53 |
| Control Group | Quality of Life - Fibromyalgia Impact Questionnaire | After 32 weeks | 5.9 units on a scale | Standard Deviation 1.86 |
| Dance Group | Quality of Life - Fibromyalgia Impact Questionnaire | Baseline | 5.89 units on a scale | Standard Deviation 1.39 |
| Dance Group | Quality of Life - Fibromyalgia Impact Questionnaire | After 16 weeks | 4.69 units on a scale | Standard Deviation 1.73 |
| Dance Group | Quality of Life - Fibromyalgia Impact Questionnaire | After 32 weeks | 4.26 units on a scale | Standard Deviation 1.81 |
p-value: <0.003ANOVA
Secondary
Quality of Life - SF-36 - Emotional Aspects
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - SF-36 - Emotional Aspects | Baseline | 21.2 units on a scale | Standard Deviation 33.1 |
| Control Group | Quality of Life - SF-36 - Emotional Aspects | After 16 weeks | 17.5 units on a scale | Standard Deviation 26.1 |
| Control Group | Quality of Life - SF-36 - Emotional Aspects | After 32 weeks | 31.5 units on a scale | Standard Deviation 38.7 |
| Dance Group | Quality of Life - SF-36 - Emotional Aspects | Baseline | 34.2 units on a scale | Standard Deviation 36.9 |
| Dance Group | Quality of Life - SF-36 - Emotional Aspects | After 16 weeks | 55 units on a scale | Standard Deviation 33.6 |
| Dance Group | Quality of Life - SF-36 - Emotional Aspects | After 32 weeks | 51.9 units on a scale | Standard Deviation 39.6 |
p-value: 0.003ANOVA
Secondary
Quality of Life - SF-36 -Functional Capacity
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - SF-36 -Functional Capacity | Baseline | 32.6 units on a scale | Standard Deviation 18.9 |
| Control Group | Quality of Life - SF-36 -Functional Capacity | After 16 weeks | 33.1 units on a scale | Standard Deviation 18.6 |
| Control Group | Quality of Life - SF-36 -Functional Capacity | After 32 weeks | 39.1 units on a scale | Standard Deviation 22 |
| Dance Group | Quality of Life - SF-36 -Functional Capacity | Baseline | 44.9 units on a scale | Standard Deviation 18.9 |
| Dance Group | Quality of Life - SF-36 -Functional Capacity | After 16 weeks | 52.9 units on a scale | Standard Deviation 21.1 |
| Dance Group | Quality of Life - SF-36 -Functional Capacity | After 32 weeks | 56.3 units on a scale | Standard Deviation 19.9 |
p-value: 0.146ANOVA
Secondary
Quality of Life - Sf-36 - General Health State
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - Sf-36 - General Health State | Baseline | 38 units on a scale | Standard Deviation 16.5 |
| Control Group | Quality of Life - Sf-36 - General Health State | After 16 weeks | 38.1 units on a scale | Standard Deviation 18.3 |
| Control Group | Quality of Life - Sf-36 - General Health State | After 32 weeks | 41.5 units on a scale | Standard Deviation 21.4 |
| Dance Group | Quality of Life - Sf-36 - General Health State | Baseline | 46 units on a scale | Standard Deviation 21.7 |
| Dance Group | Quality of Life - Sf-36 - General Health State | After 16 weeks | 45 units on a scale | Standard Deviation 21.3 |
| Dance Group | Quality of Life - Sf-36 - General Health State | After 32 weeks | 44.9 units on a scale | Standard Deviation 15.6 |
p-value: 0.58ANOVA
Secondary
Quality of Life - SF-36 - Mental Health
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - SF-36 - Mental Health | Baseline | 43.4 units on a scale | Standard Deviation 24 |
| Control Group | Quality of Life - SF-36 - Mental Health | After 16 weeks | 44.5 units on a scale | Standard Deviation 26.6 |
| Control Group | Quality of Life - SF-36 - Mental Health | After 32 weeks | 46.2 units on a scale | Standard Deviation 22.6 |
| Dance Group | Quality of Life - SF-36 - Mental Health | After 16 weeks | 54.2 units on a scale | Standard Deviation 20.7 |
| Dance Group | Quality of Life - SF-36 - Mental Health | Baseline | 46 units on a scale | Standard Deviation 19.9 |
| Dance Group | Quality of Life - SF-36 - Mental Health | After 32 weeks | 52.3 units on a scale | Standard Deviation 20.8 |
p-value: 0.021ANOVA
Secondary
Quality of Life - Sf-36 - Pain
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - Sf-36 - Pain | Baseline | 25.7 units on a scale | Standard Deviation 13.4 |
| Control Group | Quality of Life - Sf-36 - Pain | After 16 weeks | 25.1 units on a scale | Standard Deviation 14.2 |
| Control Group | Quality of Life - Sf-36 - Pain | After 32 weeks | 29.1 units on a scale | Standard Deviation 21.1 |
| Dance Group | Quality of Life - Sf-36 - Pain | Baseline | 29.6 units on a scale | Standard Deviation 17.5 |
| Dance Group | Quality of Life - Sf-36 - Pain | After 16 weeks | 44.7 units on a scale | Standard Deviation 20.7 |
| Dance Group | Quality of Life - Sf-36 - Pain | After 32 weeks | 46 units on a scale | Standard Deviation 19.2 |
p-value: <0.001ANOVA
Secondary
Quality of Life - SF-36 - Physical Limitation
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - SF-36 - Physical Limitation | Baseline | 8.8 units on a scale | Standard Deviation 17.9 |
| Control Group | Quality of Life - SF-36 - Physical Limitation | After 16 weeks | 10.4 units on a scale | Standard Deviation 21.6 |
| Control Group | Quality of Life - SF-36 - Physical Limitation | After 32 weeks | 13.8 units on a scale | Standard Deviation 26.5 |
| Dance Group | Quality of Life - SF-36 - Physical Limitation | Baseline | 24.7 units on a scale | Standard Deviation 32.2 |
| Dance Group | Quality of Life - SF-36 - Physical Limitation | After 16 weeks | 40.5 units on a scale | Standard Deviation 30.6 |
| Dance Group | Quality of Life - SF-36 - Physical Limitation | After 32 weeks | 36.5 units on a scale | Standard Deviation 13.8 |
p-value: 0.131ANOVA
Secondary
Quality of Life - SF-36 - Social Aspects
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - SF-36 - Social Aspects | Baseline | 47.6 units on a scale | Standard Deviation 23.1 |
| Control Group | Quality of Life - SF-36 - Social Aspects | After 16 weeks | 47.6 units on a scale | Standard Deviation 24.5 |
| Control Group | Quality of Life - SF-36 - Social Aspects | After 32 weeks | 51.3 units on a scale | Standard Deviation 25.5 |
| Dance Group | Quality of Life - SF-36 - Social Aspects | After 32 weeks | 57.2 units on a scale | Standard Deviation 27 |
| Dance Group | Quality of Life - SF-36 - Social Aspects | Baseline | 52.6 units on a scale | Standard Deviation 27.7 |
| Dance Group | Quality of Life - SF-36 - Social Aspects | After 16 weeks | 64.1 units on a scale | Standard Deviation 28 |
p-value: 0.055ANOVA
Secondary
Quality of Life - SF-36 - Vitality
score between 0 from 100, with higher scores denoting better quality of life
Time frame: baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Quality of Life - SF-36 - Vitality | Baseline | 29 units on a scale | Standard Deviation 18.2 |
| Control Group | Quality of Life - SF-36 - Vitality | After 16 weeks | 30.7 units on a scale | Standard Deviation 18.1 |
| Control Group | Quality of Life - SF-36 - Vitality | After 32 weeks | 37.1 units on a scale | Standard Deviation 21.8 |
| Dance Group | Quality of Life - SF-36 - Vitality | Baseline | 41.3 units on a scale | Standard Deviation 18.8 |
| Dance Group | Quality of Life - SF-36 - Vitality | After 16 weeks | 50 units on a scale | Standard Deviation 22.8 |
| Dance Group | Quality of Life - SF-36 - Vitality | After 32 weeks | 47.6 units on a scale | Standard Deviation 24.5 |
p-value: 0.082ANOVA
Secondary
Self-image - Body Dysmorphic Disorder Examination Questionnaire
scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image
Time frame: Baseline, after 16 weeks and after 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Self-image - Body Dysmorphic Disorder Examination Questionnaire | After 32 weeks | 46.9 units on a scale | Standard Deviation 31.8 |
| Control Group | Self-image - Body Dysmorphic Disorder Examination Questionnaire | Baseline | 48.8 units on a scale | Standard Deviation 34.2 |
| Control Group | Self-image - Body Dysmorphic Disorder Examination Questionnaire | After 16 weeks | 50.5 units on a scale | Standard Deviation 29.4 |
| Dance Group | Self-image - Body Dysmorphic Disorder Examination Questionnaire | Baseline | 42.8 units on a scale | Standard Deviation 32.6 |
| Dance Group | Self-image - Body Dysmorphic Disorder Examination Questionnaire | After 16 weeks | 33.6 units on a scale | Standard Deviation 25.9 |
| Dance Group | Self-image - Body Dysmorphic Disorder Examination Questionnaire | After 32 weeks | 41.1 units on a scale | Standard Deviation 24.4 |
p-value: 0.009ANOVA