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Exercise, Acupuncture and Fibromyalgia

U

University of Sao Paulo

Status

Unknown

Conditions

Fibromyalgia
Juvenile

Treatments

Procedure: acupuncture
Procedure: exercise training
Procedure: Exercise, Acupuncture and Fibromyalgia

Study type

Interventional

Funder types

Other

Identifiers

NCT01163409
exercisefibro

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

60 participants in 4 patient groups

acupuncture
Experimental group
Description:
will be made with classic acupuncture needling in traditional points, surpassing the skin
Treatment:
Procedure: Exercise, Acupuncture and Fibromyalgia
Procedure: acupuncture
sham acupuncture
Experimental group
Description:
sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points.
Treatment:
Procedure: Exercise, Acupuncture and Fibromyalgia
exercise training resistance and aerobic
Experimental group
Description:
Aerobic exercise for 1 hour and resistance exercises for major muscle groups.
Treatment:
Procedure: Exercise, Acupuncture and Fibromyalgia
Procedure: exercise training
healthy lifestyle
No Intervention group
Description:
Group 4 - will be the control group who receive follow-up and recommendation for physical activity, but without any intervention supervised.
Treatment:
Procedure: Exercise, Acupuncture and Fibromyalgia

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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