Back to resultsDance-movement Therapy Programme in Fibromyalgia.
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dance-movement therapy
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring dance-movement therapy, balance, Fibromyalgia
Eligibility Criteria
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.
Sites / Locations
- University of GranadaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Patients with fibromyalgia included in a dance-movement therapy programme
Patients with fibromyalgia who receive a standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
Outcomes
Primary Outcome Measures
Changes in balance
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
Secondary Outcome Measures
Changes in quadriceps strength
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.
Changes in quality of life
Quality of life associated with health. This is going to be measure with the EuroQol-5 questionnaire.
Changes in flexibility of lower limbs
Changes from baseline to postintervention measured with neurodynamic tests It is going to be measured with a goniometer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02144116
Brief Title
Dance-movement Therapy Programme in Fibromyalgia.
Official Title
Effects of a Dance-movement Therapy Programme in Patients With Fibromyalgia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalized hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms like fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. This condition is very prevalent. It has been reported to be about 2-5% of the general global population. Fibromyalgia is associated with balance problems and increased fall frequency. The objective of this study was to examine the effects of an 8 weeks dance-movement therapy programme on balance, strength, flexibility and quality of life in patients with fibromyalgia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
dance-movement therapy, balance, Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients with fibromyalgia included in a dance-movement therapy programme
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients with fibromyalgia who receive a standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
Intervention Type
Other
Intervention Name(s)
Dance-movement therapy
Other Intervention Name(s)
intervention, dance therapy, occupational therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Control, Education
Intervention Description
Standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
Primary Outcome Measure Information:
Title
Changes in balance
Description
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
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Changes in quadriceps strength
Description
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.
Time Frame
Baseline, 8 weeks
Title
Changes in quality of life
Description
Quality of life associated with health. This is going to be measure with the EuroQol-5 questionnaire.
Time Frame
Baseline, 8 weeks
Title
Changes in flexibility of lower limbs
Description
Changes from baseline to postintervention measured with neurodynamic tests It is going to be measured with a goniometer.
Time Frame
Baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958248035
Email
cvalenza@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Phone
958242360
Email
cvalenza@ugr.es
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dance-movement Therapy Programme in Fibromyalgia.
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