NCT01586637

Brief Summary

Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

February 16, 2012

Last Update Submit

April 25, 2012

Conditions

Fibromyalgia

Keywords

FibromyalgiaArt TherapyPainQuality of lifeBody Image

Outcome Measures

Primary Outcomes (1)

  • Change in Pain

    Evaluated with the visual analogue scale

    baseline, after 10 weeks, 20 weeks and 40 weeks

Secondary Outcomes (4)

  • Change in fibromyalgia impact

    Baseline, after 10, 20 and 40 weeks

  • Change in Quality of life

    Baseline, after 10, 20 and 40 weeks

  • Change in Body image

    Basline, after 10, 20 and 40 weeks

  • Change in Functional capacity

    Baseline, after 10, 20 and 40 weeks

Study Arms (2)

Art Therapy

EXPERIMENTAL

This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week.

Other: Art Therapy

Walking

EXPERIMENTAL

The group walked twice a week during one hour.

Other: Walking

Interventions

Art TherapyOTHER

This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week.

Also known as: Rehabilitation, exercise, physical therapy
Art Therapy
WalkingOTHER

The group walked twice a week during one hour.

Also known as: Rehabilitation, exercise, physical therapy
Walking

Eligibility Criteria

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

You may qualify if:

  • Classification of fibromyalgia by ACR criteria (Wolf et al, 1990)
  • Females
  • Without distinction of race
  • Age 18 to 65 years
  • Do not have changed treatment for fibromyalgia for at least 3meses
  • signing the consent form

You may not qualify if:

  • Other ostearticulares rheumatic and painful
  • Decompensated cardio-respiratory diseases
  • Perform physical activity more than 2x a week for more than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andréia Salvador Baptista

São Paulo, São Paulo, 03237070, Brazil

Location

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Art TherapyRehabilitationExercisePhysical Therapy ModalitiesWalking

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotion

Study Officials

  • Andréia S Baptista, PT, MSc

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2012

First Posted

April 27, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

BR(1)