NCT01163409

Brief Summary

Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, who just get guidance for physical activity.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 19, 2012

Status Verified

June 1, 2010

Enrollment Period

2 years

First QC Date

June 9, 2010

Last Update Submit

January 18, 2012

Conditions

FibromyalgiaJuvenile

Keywords

juvenile fibromyalgiaacupunctureexercise training

Outcome Measures

Primary Outcomes (1)

  • pain

    Clinical evaluation of pain is made by a general questionnaire for pain and overall evaluation of the patient / family and professional by the Visual Analogue Scale. There will be pain as described in 18 points for fibromyalgia, using as instrument the pressure algiômetro Fischer, settling myalgic index.

    14 weeks

Secondary Outcomes (2)

  • quality of life

    14 weeks

  • strength

    14 weeks

Study Arms (4)

acupuncture

EXPERIMENTAL

will be made with classic acupuncture needling in traditional points, surpassing the skin

Procedure: acupunctureProcedure: Exercise, Acupuncture and Fibromyalgia

sham acupuncture

EXPERIMENTAL

sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points.

Procedure: Exercise, Acupuncture and Fibromyalgia

exercise training resistance and aerobic

EXPERIMENTAL

Aerobic exercise for 1 hour and resistance exercises for major muscle groups.

Procedure: exercise trainingProcedure: Exercise, Acupuncture and Fibromyalgia

healthy lifestyle

NO INTERVENTION

Group 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised.

Procedure: Exercise, Acupuncture and Fibromyalgia

Interventions

exercise trainingPROCEDURE

exercise training comprises aerobic and strength training

Also known as: Multidisciplinary treatment including medication, Family education, Psychotherapy, Interventions to reduce pain, Improve sleep quality.
exercise training resistance and aerobic
acupuncturePROCEDURE

acupuncture involves two sessions per week, during 14 weeks.

Also known as: Systematic study of physical activity and acupuncture have stimulated
acupuncture
Exercise, Acupuncture and FibromyalgiaPROCEDURE

Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, we just get guidance for physical activity.

Also known as: Assess pain reduction, Improvement in quality of life in children and adolescents, Compare four treatment groups
acupunctureexercise training resistance and aerobichealthy lifestylesham acupuncture

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Juvenile fibromyalgia diagnosis
  • Age between ten to seventeen years and eleven months

You may not qualify if:

  • Previous treatment with acupuncture;
  • Treatment with psychotherapy, exercise training, use of antidepressant and anti-inflammatory drugs in the last month;
  • Inflammatory diseases, hypothyroidism and hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Magda Maria Maia

São Paulo, São Paulo, 5511, Brazil

Location

University of Sao Paulo

São Paulo, São Paulo, 5511, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

ExerciseSex EducationPsychotherapyAcupuncture TherapyQuality of Life

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSexologyBehavioral SciencesBehavioral Disciplines and ActivitiesComplementary TherapiesTherapeuticsHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Clóvis AA Silva, M.D, Ph.D

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2010

First Posted

July 15, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2014

Last Updated

January 19, 2012

Record last verified: 2010-06

Locations

BR(2)