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Completed

NCT Number: NCT03971890

Effectiveness of Dance Therapy in Fibromyalgia.

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dance therapy

Other

The experimental group will receive a dance treatment.This protocol will be administered at weekly sessions of 60 minutes with a period of 2 times / week with a total of 16 sessions, distributed over a 8-week period. They will be evaluated at baseline, after the end of the last treatment session.

Other names: Exercise treatment

Educational group

Other

The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.

Other names: Control group

Primary outcomes

  1. Timed Up and Go (TUG)

    Time frame: 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 outcomes

  1. One leg stance

    Time frame: 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.

  2. SLUMP Test

    Time frame: 8 weeks

    Change from de baseline in the movement of the pain-sensitive nerve structures.

  3. Straight Leg Raise test (SLR)

    Time frame: 8 weeks

    Change from de baseline in the movement of the pain-sensitive nerve structures.

  4. Revised Fibromyalgia Impact Questionnaire (FIQR)

    Time frame: 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.

  5. Sheehan Disability Scale (SDS)

    Time frame: 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.

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  7. Athens Insomnia Scale (AIS)

    Time frame: 8 weeks

    Change from the baseline on insomnia. It is a self-rating instrument of eigth items.

  8. Spanish version of the Brief Pain Inventory questionnaire (CBD)

    Time frame: 8 weeks

    Change from the baseline on the intensity of pain and its impact on activities of daily living.

  9. Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Time frame: 8 weeks

    Change from the baseline on physical disability related to activities of eight categories of daily living over the last week.

  10. Epworth Sleepiness Scale, (EES)

    Time frame: 8 weeks

    Change from thebaseline of the subject's general level of daytime sleepiness.

  11. Minibestest

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Effectiveness of a Exercise Program Based on Dance Therapy in Fibromyalgia: A Randomized Controlled Trial.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 3, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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