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CompletedNCT03971890Updated Oct 1, 2019

Effectiveness of Dance Therapy in Fibromyalgia.

An interventional study of Dance therapy and Educational group in Fibromyalgia, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Fibromyalgia

Keywords

  • Balance
  • Pain
  • TUG
  • Dance
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 70 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    DanceTherapy Group

    The experimental group will receive a dance treatment.

    Other: Dance therapy

  • Experimental
    Control Group

    The control group will be subjected to a educational treatment.

    Other: Educational group

Interventions

  • OtherDance therapy

    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.

    Also known as: Exercise treatment

  • OtherEducational group

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

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. Timed Up and Go (TUG)

    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.

    Time frame: 8 weeks

Secondary outcomes

  1. One leg stance

    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.

    Time frame: 8 weeks

  2. SLUMP Test

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

    Time frame: 8 weeks

  3. Straight Leg Raise test (SLR)

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

    Time frame: 8 weeks

  4. Revised Fibromyalgia Impact Questionnaire (FIQR)

    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.

    Time frame: 8 weeks

  5. Sheehan Disability Scale (SDS)

    Change from the baseline on the severity of general disability in the items of work, family life/home responsibilities and social life/leisure activities.

    Time frame: 8 weeks

  6. Pittsburgh Sleep Quality Index (PSQI)

    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.

    Time frame: 8 weeks

  7. Athens Insomnia Scale (AIS)

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

    Time frame: 8 weeks

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

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

    Time frame: 8 weeks

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

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

    Time frame: 8 weeks

  10. Epworth Sleepiness Scale, (EES)

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

    Time frame: 8 weeks

  11. Minibestest

    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.

    Time frame: 8 Weeks

07

Study locations

1 site
  • University of Granada
    Granada, 18001, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03971890
Lead sponsor
Universidad de Granada
Responsible party
Encarnación Aguilar Ferrandiz (Research and teaching staff of the University of Granada, Universidad de Granada) — Principal investigator
First posted
Jun 3, 2019
Start date
Apr 22, 2019
Primary completion
Aug 21, 2019
Completion
Sep 21, 2019
Last update
Oct 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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