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Dance-movement Therapy Programme in Fibromyalgia.

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ClinicalTrials.gov Identifier: NCT02144116
Recruitment Status : Unknown
Verified October 2016 by Marie Carmen Valenza, Universidad de Granada.
Recruitment status was:  Recruiting
First Posted : May 21, 2014
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Tracking Information
First Submitted Date  ICMJE May 19, 2014
First Posted Date  ICMJE May 21, 2014
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02144116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
  • 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.
  • Changes in quality of life [ Time Frame: Baseline, 8 weeks ]
    Quality of life associated with health. This is going to be measure with the EuroQol-5 questionnaire.
  • Changes in flexibility of lower limbs [ Time Frame: Baseline, 8 weeks ]
    Changes from baseline to postintervention measured with neurodynamic tests It is going to be measured with a goniometer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dance-movement Therapy Programme in Fibromyalgia.
Official Title  ICMJE Effects of a Dance-movement Therapy Programme in Patients With Fibromyalgia.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Other: Dance-movement therapy
    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:
    • intervention
    • dance therapy
    • occupational therapy
  • Other: Control group
    Standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
    Other Names:
    • Control
    • Education
Study Arms  ICMJE
  • Experimental: Experimental group
    Patients with fibromyalgia included in a dance-movement therapy programme
    Intervention: Other: Dance-movement therapy
  • 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.
    Intervention: Other: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
48
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2014)
40
Estimated Study Completion Date  ICMJE January 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02144116
Other Study ID Numbers  ICMJE DF0052UG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marie Carmen Valenza, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada
PRS Account Universidad de Granada
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP