- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02144116
Dance-movement Therapy Programme in Fibromyalgia.
Effects of a Dance-movement Therapy Programme in Patients With Fibromyalgia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fibromyalgia is a chronic condition associated with balance problems and pain. It has been previously described that fibromyalgia may affect peripheral and/or central mechanisms of postural control. Balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance.
Patients with fibromyalgia have also muscle weakness. Muscle strength depends on both the cross-sectional area of the muscle and the neural activity. Range of movement and quality of life have also been reported to be affected.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Granada, Spain, 18071
- Recruiting
- University of Granada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women diagnosed of Fibromyalgia attending to the Fibromyalgia Association of Granada.
- Women who can complete the assessment battery of tests at the beginning and at the end of the study
Exclusion Criteria:
- Auditive and visual disturbances.
- Cognitive problems.
- Psychiatric pathology.
- Traumatic pathology of lower limbs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
Patients with fibromyalgia included in a dance-movement therapy programme
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The dance-movement was practised in groups.
Dance-movement therapy derived from dance education.
The goals of dance-movement therapy included assessing patient needs, communicating emotions, improving self-control, organizing thoughts and actions, developing interpersonal skills, integrating physical and emotional selves, promoting body awareness, and supporting healing.
Other Names:
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Active Comparator: Control group
Patients with fibromyalgia who receive a standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
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Standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in balance
Time Frame: Baseline, 8 weeks
|
Balance is going to be assessed with the Mini BalanceEvaluation System Test. This test assesses dynamic balance, with four subscales:anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The Mini BESTest is a 14 item test scored on a 3 level ordinal scale. For the Mini BESTest, the original BESTest 4 level (0 - 3) scoring was revised to 3 levels (0 - 2) due to redundancy. Total score = 28 points per test directions. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, many studies specify use of both left and right data, thus calculating data based on 32 (vs 28) points |
Baseline, 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in quadriceps strength
Time Frame: Baseline, 8 weeks
|
Changes from baseline to postintervention on quadriceps strength.
This will be measured using a Jamar dynamometer with a standard protocol allowing three attempts on each side.
The maximum value achieved from all six attempts was used in analyses.
Kg/cm2.
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Baseline, 8 weeks
|
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Changes in quality of life
Time Frame: Baseline, 8 weeks
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Quality of life associated with health.
This is going to be measure with the EuroQol-5 questionnaire.
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Baseline, 8 weeks
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Changes in flexibility of lower limbs
Time Frame: Baseline, 8 weeks
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Changes from baseline to postintervention measured with neurodynamic tests It is going to be measured with a goniometer.
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Baseline, 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0052UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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