NCT02144116

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

May 19, 2014

Last Update Submit

October 27, 2016

Conditions

Fibromyalgia

Keywords

dance-movement therapybalanceFibromyalgia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Changes in quadriceps strength

    Baseline, 8 weeks

  • Changes in quality of life

    Baseline, 8 weeks

  • Changes in flexibility of lower limbs

    Baseline, 8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients with fibromyalgia included in a dance-movement therapy programme

Other: Dance-movement therapy

Control group

ACTIVE COMPARATOR

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

Interventions

Dance-movement therapyOTHER

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.

Also known as: intervention, dance therapy, occupational therapy
Experimental group
Control groupOTHER

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

Also known as: Control, Education
Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Auditive and visual disturbances.
  • Cognitive problems.
  • Psychiatric pathology.
  • Traumatic pathology of lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, Granada, 18071, Spain

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

MethodsDance TherapyOccupational TherapyControl GroupsEducational Status

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesSensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CareExercise Movement TechniquesPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsResearch DesignSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Carmen Valenza, PhD

CONTACT

958248035cvalenza@ugr.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor assistant

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 21, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

ES(1)