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临床试验/NCT02181166
NCT02181166Unknown不适用

Diagnosis and Management of Myofascial Pain Syndrome in Women With Mastectomies

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014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
入组人数
60
试验地点
1
主要终点
Pain

研究概览

简要总结

Myofascial pain considerably affects women undergoing treatment for breast cancer, is characterized by the presence of myofascial taut bands and trigger points. This study aims to evaluate the effects of ischemic compression, high-voltage electrical stimulation and rehabilitation of kinesio in women with myofascial pain following treatment of breast cancer. This is a randomized blind controlled study. For this, we invited 60 volunteers undergoing treatment for breast cancer, randomized and allocated into three groups: G1 (cinesioterapia), G2 (ischemic compression cinesioterapia +) and G3 (high voltage electrical stimulation cinesioterapia +). The stance, the plantar pressure distribution and the balance will be assessed by means of photogrammetry and baropodometry respectively. Myofascial trigger points will be assessed with the use of infrared thermography, algometry and numerical rating scale of pain (END). Moreover, the quality of life of the volunteers will be assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B +4). The volunteers will undergo 10 sessions of treatment, and reassessed at the end of treatment and after thirty days. Normality test is used to verify data distribution and consistent statistical test for proper intra and comparisons between groups, being thus considered two factors in the comparisons, time and group. A significance level of 5% is assumed.

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
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •mastectomy
  • •aged between 35 and 70 years
  • •myofascial trigger point in the upper trapezius muscle

排除标准

  • •metastasis or recurrence of breast cancer
  • •bilateral mastectomy
  • •in physiotherapy treatment
  • •degenerative diseases of the spine
  • •use of muscle relaxants or anti-inflammatory analgesics in the last week
  • •report of fibromyalgia

研究组 & 干预措施

kinesiotherapy + High voltage electrical stimulation

Experimental

Same protocol group kinesiotherapy + high voltage electrial stimulation with two rectangular electrodes (3x5 cm) active silicon-carbon and an electrode rectangular dispersive (10x18cm) aluminum wrapped with a damp felt in water. The active electrodes are positioned in central myofascial trigger point of the upper trapezius muscle after application of water soluble gel. The dispersive electrode was placed in the lumbar region. The following parameters will be use: frequency of 10 Hz, twin pulses of 20μs to 100ms between pulses and the maximum voltage tolerated by voluntary until the motor threshold (visible muscle contraction) to increase every five minutes, totaling 30 minutes of stimulation. The negative polarity will be use.

干预措施: Kinesiotherapy (Other)

kinesiotherapy + High voltage electrical stimulation

Experimental

Same protocol group kinesiotherapy + high voltage electrial stimulation with two rectangular electrodes (3x5 cm) active silicon-carbon and an electrode rectangular dispersive (10x18cm) aluminum wrapped with a damp felt in water. The active electrodes are positioned in central myofascial trigger point of the upper trapezius muscle after application of water soluble gel. The dispersive electrode was placed in the lumbar region. The following parameters will be use: frequency of 10 Hz, twin pulses of 20μs to 100ms between pulses and the maximum voltage tolerated by voluntary until the motor threshold (visible muscle contraction) to increase every five minutes, totaling 30 minutes of stimulation. The negative polarity will be use.

干预措施: High voltage electrical stimulation (Other)

Kinesiotherapy group

Experimental

The volunteer will be subjected to the following protocol: These exercises involve stretching of the cervical, anterior and posterior chain of the upper trunk and active mobilization of the cervical, shoulder movements of flexion, extension, abduction and adduction of the shoulder and upper limb. The exercises lasted 50 minutes, with 10 minutes of walking, and stretching was performed with two repetitions of 20 seconds, and active mobilization exercises of three sets of eight repetitions and final relaxation of 10 minutes were performed.

干预措施: Kinesiotherapy (Other)

kineshioterapy + isquemic compression

Experimental

The same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle. This procedure was performed for 90 seconds.

干预措施: Isquemic compression (Other)

kineshioterapy + isquemic compression

Experimental

The same protocol group kinesiotherapy + ischemic compression in central myofascial trigger point of the upper trapezius muscle. This procedure was performed for 90 seconds.

干预措施: Kinesiotherapy (Other)

结局指标

主要结局

Pain

时间窗: 2 years

Will be apply the following assessment tools: algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).

次要结局

  • Posture(2 years)
  • Quality of life(2 years)
  • Skin Temperature(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vânia Tie Koga Ferreira

PT

University of Sao Paulo

研究点 (1)

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