Effectiveness of Dance Therapy in Fibromyalgia.

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Dance therapy; Other: Educational group

• Registration Number: NCT03971890
• Lead Sponsor: Universidad de Granada

Brief Summary

The purpose of this study is to analyze the effects of an intervention with dance on balance,movility, pain and sleep in patients with Fibromyalgia in comparison to a control group that will have an educational intervention.

Detailed Description

Fibromyalgia is a chronic disease consisting of widespread pain, fatigue, sleep disturbances, and cognitive impairments, among other symptoms, which affect daily physical activity.

The regular physical exercise improves the functional, physiological, and behavioral components of physical fitness. Dance therapy seems to increase motivation and adherence to therapy, and can provide a real alternative to conventional exercise

The experimental group will receive a dance program treatment .

The control group will receive an educational intervention.

Study Timeline

• Study Start: 2019-04-22
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Primary Completion: 2019-08-21
• Status Verified: 2019-09
• Study Completion: 2019-09-21
• Last Update Submitted: 2019-09-28
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Being over 18 years of age until 64.
• Being diagnosed with FMS in accordance with American College of Rheumatology - ACR

Exclusion Criteria

• Participants with diagnoses of other inflammatory rheumatic diseases, previous neurological or orthopedic diseases,
• Use aids for balance, hearing and visual problems.
• Cognitive impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DanceTherapy Group	Dance therapy	The experimental group will receive a dance treatment.
Control Group	Educational group	The control group will be subjected to a educational treatment.

Primary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG)	8 weeks	Change from de baseline in functional mobility and predict risk of falls. The single-task subscale consists of a measurement of the time in seconds for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The dual task subscale adds a cognitive task (TUGCognitive) or a manual task (TUGManual) to the simple task.

Secondary Outcome Measures

Name	Time	Method
SLUMP Test	8 weeks	Change from de baseline in the movement of the pain-sensitive nerve structures.
Straight Leg Raise test (SLR)	8 weeks	Change from de baseline in the movement of the pain-sensitive nerve structures.
Revised Fibromyalgia Impact Questionnaire (FIQR)	8 weeks	Change from the baseline on the impact of symptoms on quality of life in people with fibromyalgia. Questionnaire with 21-items on a visual analogue scale.
Spanish version of the Brief Pain Inventory questionnaire (CBD)	8 weeks	Change from the baseline on the intensity of pain and its impact on activities of daily living.
One leg stance	8 weeks	Change from de baseline in postural steadiness (static balance) in a static position by registering the number of seconds a person can maintain this position.
Athens Insomnia Scale (AIS)	8 weeks	Change from the baseline on insomnia. It is a self-rating instrument of eigth items.
Epworth Sleepiness Scale, (EES)	8 weeks	Change from thebaseline of the subject's general level of daytime sleepiness.
Sheehan Disability Scale (SDS)	8 weeks	Change from the baseline on the severity of general disability in the items of work, family life/home responsibilities and social life/leisure activities.
Health Assessment Questionnaire - Disability Index (HAQ-DI)	8 weeks	Change from the baseline on physical disability related to activities of eight categories of daily living over the last week.
Minibestest	8 Weeks	Change from baseline in Dynamic Balance: areas are anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability in gait. This tool has 14 items, with a maximum score of 28 points.
Pittsburgh Sleep Quality Index (PSQI)	8 weeks	change from the baseline on sleep quality. The self-rated items of the PSQI generate seven component scores (with subscales ranged 0-3): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction.

Trial Locations

Locations (1)

University of Granada; 🇪🇸 Granada, Spain