Dance-movement Therapy Programme in Fibromyalgia.

Fibromyalgia Clinical Trial

Official title:

Effects of a Dance-movement Therapy Programme in Patients With Fibromyalgia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144116
• Other study ID #: DF0052UG
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2014
• Last updated: October 27, 2016
• Start date: May 2014
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Universidad de Granada
• Contact: Marie Carmen Valenza, PhD
• Phone: 958248035
• Email: cvalenza[@]ugr.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• Control group
Standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 8 weeks	Yes
Secondary	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.	Baseline, 8 weeks	Yes
Secondary	Changes in quality of life	Quality of life associated with health. This is going to be measure with the EuroQol-5 questionnaire.	Baseline, 8 weeks	Yes
Secondary	Changes in flexibility of lower limbs	Changes from baseline to postintervention measured with neurodynamic tests It is going to be measured with a goniometer.	Baseline, 8 weeks	Yes