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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | will be made with classic acupuncture needling in traditional points, surpassing the skin |
|
| sham acupuncture | Experimental | sham acupuncture will be done through a needle and a plastic device attached to skin in traditional acupuncture points. |
|
| exercise training resistance and aerobic | Experimental | Aerobic exercise for 1 hour and resistance exercises for major muscle groups. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise training | Procedure | exercise training comprises aerobic and strength training |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clóvis AA Silva, M.D, Ph.D | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magda Maria Maia | São Paulo | São Paulo | 5511 | Brazil | ||
| University of Sao Paulo |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D012736 | Sex Education |
| D011613 | Psychotherapy |
| D015670 | Acupuncture Therapy |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| acupuncture | Procedure | acupuncture involves two sessions per week, during 14 weeks. |
|
|
| Exercise, Acupuncture and Fibromyalgia | 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. |
|
|
will be assessed by means of 1-RM test |
| 14 weeks |
| São Paulo |
| São Paulo |
| 5511 |
| Brazil |
| D009422 |
| Nervous System Diseases |
| D044347 | Sexology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |