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临床试验/NCT01163409
NCT01163409Unknown不适用

Acupuncture and Physical Activity in Patients With Fibromyalgia

University of Sao Paulo4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
4
主要终点
pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

pain

时间窗: 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.

次要结局

  • quality of life(14 weeks)
  • strength(14 weeks)

研究者

申办方类型
Other

研究点 (4)

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