Exercise, Acupuncture and Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia; Juvenile
• Interventions: Procedure: acupuncture; Procedure: exercise training; Procedure: Exercise, Acupuncture and Fibromyalgia

• Registration Number: NCT01163409
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Fibromyalgia syndrome is a chronic musculoskeletal pain of unknown etiology. It is characterized by diffuse musculoskeletal pain or painful specific sites, usually accompanied by sleep disorders, fatigue, morning stiffness, chronic headaches, mental disorders and functional bowel. The diagnosis is essentially clinical, with no abnormal laboratory and radiological features Physical exercises are part of the treatment of fibromyalgia, but does not report studies in children. In general children with fibromyalgia are encouraged to a multidisciplinary treatment including medication, family education and child graduated aerobic exercise, psychotherapy, interventions to reduce pain, stress and improve sleep quality. To date no studies in medical literature with the use of acupuncture and supervised physical activity in juvenile fibromyalgia.

The significant sample of this disease, our recent publications in this research and the lack of systematic study of physical activity and acupuncture have stimulated this research. Assess pain reduction and improvement in quality of life in children and adolescents with juvenile fibromyalgia.

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19
• Primary Completion: 2012-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
acupuncture	acupuncture	will be made with classic acupuncture needling in traditional points, surpassing the skin
acupuncture	Exercise, Acupuncture and Fibromyalgia	will be made with classic acupuncture needling in traditional points, surpassing the skin
sham acupuncture	Exercise, Acupuncture and Fibromyalgia	sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points.
exercise training resistance and aerobic	exercise training	Aerobic exercise for 1 hour and resistance exercises for major muscle groups.
exercise training resistance and aerobic	Exercise, Acupuncture and Fibromyalgia	Aerobic exercise for 1 hour and resistance exercises for major muscle groups.
healthy lifestyle	Exercise, Acupuncture and Fibromyalgia	Group 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised.

Primary Outcome Measures

Name	Time	Method
pain	14 weeks	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.

Secondary Outcome Measures

Name	Time	Method
strength	14 weeks	will be assessed by means of 1-RM test
quality of life	14 weeks	Functional assessment of quality of life will be made by the Childhood Health Assessment Questionnaire (CHAQ) of pediatric Peds QL questionnaire that will be answered by the patients and their parents in age groups: 9-12 years and 13-18 years.

Trial Locations

Locations (2)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Magda Maria Maia; 🇧🇷 São Paulo, Brazil