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临床试验/NCT02691208
NCT02691208已完成不适用

Effectiveness of Acupuncture in Rehabilitation of Physical and Functional Disorders of Women Undergoing Breast câncer Surgery

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Result of rehabilitation about pain, Shoulder Range of Motion, lymphedema presence, upper limb function, Depressive symptoms, Quality of life and Muscle strength with kinesioterapy and acupuncture

研究概览

简要总结

The patients were divided into two randomized groups with 24 patients per group, which were given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes and the other group followed Kinesiotherapy the same protocol for another 30 minutes acupuncture using predefined points.

The patients were assessed at baseline, after five weeks and at the end of 10 weeks. Responded to an evaluation form about their registration and social data. The physical examination included the assessment of shoulder range of motion, shoulder muscle strength, circumference of the upper limbs and the presence of pain. Questionnaires of quality of life, upper limb function and depression.

详细描述

They were included in this study patients undergoing surgical treatment for breast cancer, radical or conservative, and to produce pain in the region of the shoulder girdle and upper limb, including thoracic and cervical spine after three months of surgery. Patients over the age of 18 years and level of pain ≥ 3 on the Visual Analogue Scale (VAS). patients with bilateral breast surgery were excluded, metastatic disease, vascular disorders and tactile sensitivity, with diabetes mellitus type I and II uncompensated and with lower level of education than four years. The patients were divided into two randomized groups with 24 patients per group, which were given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes and the other group followed Kinesiotherapy the same protocol for another 30 minutes acupuncture using predefined points.

The patients were assessed at baseline, after five weeks and at the end of 10 weeks. Responded to an evaluation form about their registration and social data. The physical examination included the assessment of shoulder range of motion, shoulder muscle strength, circumference of the upper limbs and the presence of pain. questionnaires application EORC QLQ C30 BECK and DASH.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •underwent surgical treatment of breast cancer, radical or conservative,
  • •pain in scapular girdle, in the thoracic or cervical spine, after three months surgery.
  • •level of pain ≥ 3 in the Visual Analogue Scale

排除标准

  • •bilateral breast surgery,
  • •metastatic disease,
  • •vascular and tactile sensitivity disorders,
  • •uncompensated diabetes mellitus type I and II
  • •lower education level than four years.

研究组 & 干预措施

Group I Kinesiotherapy

Experimental

women with pain treated with a predefinided exercises protocol of 30 minutes.

干预措施: Kinesiotherapy (Other)

Group II Acupuncture

Experimental

women with pain treated with a predefinided exercises protocol of 30 minutes followed by 30 minutes of acupuncture, used in predefined points

干预措施: Acupuncture (Other)

结局指标

主要结局

Result of rehabilitation about pain, Shoulder Range of Motion, lymphedema presence, upper limb function, Depressive symptoms, Quality of life and Muscle strength with kinesioterapy and acupuncture

时间窗: two years

1. Presence of pain by Visual Analog Scale of Pain (VAS). 2. Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation 3. lymphedema presence through top member perimetry. 4. upper limb function through the DASH questionnaire. 5. Depressive symptoms through BECK questionnaire. 6. Quality of life through the EORTC questionnaire. 7. Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company.

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gil Facina

doctor

Federal University of São Paulo

研究点 (1)

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