Trial record 6 of 112 for:    fibromyalgia | Open Studies | Interventional Studies

Dance-movement Therapy Programme in Fibromyalgia.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT02144116
First received: May 19, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Fibromyalgia
Other: Dance-movement therapy
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Dance-movement Therapy Programme in Patients With Fibromyalgia.

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Changes in balance [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Changes from baseline to postintervention measured with neurodynamic tests It is going to be measured with a goniometer.


Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group
Patients with fibromyalgia included in a dance-movement therapy programme
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02144116

Contacts
Contact: Marie Carmen Valenza, PhD 958248035 cvalenza@ugr.es

Locations
Spain
University of Granada Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD    958242360    cvalenza@ugr.es   
Principal Investigator: Marie Carmen Valenza, PhD         
Sponsors and Collaborators
Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, Proffesor assistant, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02144116     History of Changes
Other Study ID Numbers: DF0052UG
Study First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
dance-movement therapy
balance
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014