Exercise, Acupuncture and Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acupuncture and Physical Activity in Patients With Fibromyalgia

Conditions
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Fibromyalgia, Juvenile

Intervention / Treatment
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* Procedure: exercise training
* Procedure: acupuncture
* Procedure: Exercise, Acupuncture and Fibromyalgia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br>will be made with classic acupuncture needling in traditional points, surpassing the skin | Procedure: acupuncture<br>* acupuncture involves two sessions per week, during 14 weeks.<br>* Other names: Systematic study of physical activity and acupuncture have stimulated;Procedure: Exercise, Acupuncture and Fibromyalgia<br>* 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.<br>* Other names: Compare four treatment groups;|
| Experimental: sham acupuncture<br>sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points. | Procedure: Exercise, Acupuncture and Fibromyalgia<br>* 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.<br>* Other names: Compare four treatment groups;|
| Experimental: exercise training resistance and aerobic<br>Aerobic exercise for 1 hour and resistance exercises for major muscle groups. | Procedure: exercise training<br>* exercise training comprises aerobic and strength training<br>* Other names: Improve sleep quality.;Procedure: Exercise, Acupuncture and Fibromyalgia<br>* 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.<br>* Other names: Compare four treatment groups;|
| No Intervention: healthy lifestyle<br>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<br>* 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.<br>* Other names: Compare four treatment groups;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | 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. | 14 weeks | 
| strength | will be assessed by means of 1-RM test | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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juvenile fibromyalgia, acupuncture, exercise training