Exercise, Acupuncture and Fibromyalgia

NCT ID: NCT01163409

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Fibromyalgia; Juvenile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

acupuncture

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

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: PROCEDURE

acupuncture involves two sessions per week, during 14 weeks.

Exercise, Acupuncture and Fibromyalgia

Intervention Type: PROCEDURE

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.

sham acupuncture

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

Group Type: EXPERIMENTAL

Exercise, Acupuncture and Fibromyalgia

Intervention Type: PROCEDURE

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.

exercise training resistance and aerobic

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

Group Type: EXPERIMENTAL

exercise training

Intervention Type: PROCEDURE

exercise training comprises aerobic and strength training

Exercise, Acupuncture and Fibromyalgia

Intervention Type: PROCEDURE

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.

healthy lifestyle

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

Group Type: NO_INTERVENTION

Exercise, Acupuncture and Fibromyalgia

Intervention Type: PROCEDURE

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.

Interventions

exercise training

exercise training comprises aerobic and strength training

Intervention Type: PROCEDURE

acupuncture

acupuncture involves two sessions per week, during 14 weeks.

Intervention Type: PROCEDURE

Exercise, Acupuncture and Fibromyalgia

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.

Intervention Type: PROCEDURE

Other Intervention Names

Multidisciplinary treatment including medication; Family education; Psychotherapy; Interventions to reduce pain; Improve sleep quality.; Systematic study of physical activity and acupuncture have stimulated; Assess pain reduction; Improvement in quality of life in children and adolescents; Compare four treatment groups

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

University of Sao Paulo

Principal Investigators

Clóvis AA Silva, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Magda Maria Maia

São Paulo, São Paulo, Brazil

University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

exercisefibro

Identifier Type: -

Identifier Source: org_study_id