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临床试验/NCT05870241
NCT05870241已完成不适用

Post-Mastectomy Shoulder Pain And Lymphedema Responses To Ga-As Laser Versus Microcurrent Electrical Stimulation

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Lymphedema volume

研究概览

简要总结

the aim of this study is to investigate the effect of GA-AS laser versus microcurrent on post-mastectomy shoulder pain and lymphedema.

详细描述

Breast cancer is extremely rare before the age of 25. It reaches a high incidence in the decade from 40 to 50 and continuous to increase in the frequency into old age. Mastectomy is the traditional approach to remove the entire breast once the diagnosis was confirmed. The most common cancers are lung cancer in men and breast cancer in women, however despite the large numbers of people affected by cancer there is very little literature on the role of physiotherapists in cancer care. After mastectomy and the accompanying excision or radiation of adjacent axillary lymph nodes a patient is at risk of developing upper extremity lymphedema, shoulder pain and loss of shoulder motion.low-level laser light waves penetrate deeply into the skin, they optimize the immune responses of our blood. This has both anti-inflammatory and immunosuppressive effects. It is a scientific fact that light transmitted to the blood in this way has positive effects throughout the whole body, supplying vital oxygen and energy to every cell .Electrical stimulation is based on the fact that human body has an endogenous bioelectric system that enhances healing of bone fracture, soft tissue lesions and decreasing post-operative pain. The external current may serve to mimic the failed natural bioelectric currents, so that post-operative pain can be inhibited. It was reported that microcurrent electrical neuromuscular stimulation (MENS) is better in enhancing cellular physiology processes than other current of higher amplitude, microcurrent is effective in the management of open wounds, inflammation and pain. sixty patients will be randomly allocated to three groups; first one will receive laser+ traditional therapy, second one will receive microcurrent + traditional therapy and third one will receive traditional therapy three times a week for three months.

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)

盲法说明

random generator

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients will be female patient. Their ages will be ranged from 40 to 55 years old. All patients will have postmastectomy shoulder pain and lymphedema. All patients will be assessed carefully by the physician before the starting of the study procedures.
  • All patients will be conscious and ambulant. All patients will have surgical mastectomy on the right breast region (site of the surgical excision is right side).
  • The common indication of breast mastectomy for all cases will be pathological disorder of the breast (breast cancer).
  • All patients will receive the same necessary or required drugs and diet regime. All patients in the three groups of the study will receive the same medications (antibiotics and diuretics) (Akai

排除标准

  • Patients who have other pathological conditions or histories except postmastectomy shoulder pain and lymphedema.
  • Patients with evidence of local recurrence or distant metastasis will be excluded from the study.
  • Patient who takes other medications that may affects the results Patients who are not ambulant Patients who have surgical mastectomy on the left side breast region not the right one.
  • Patients who are not co-operative during assessment and treatment.

结局指标

主要结局

Lymphedema volume

时间窗: up to twelve weeks

lymphedema volume will be measured by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as V=h(C12 +C1C2+C22 )/12π, where V is the volume of the segment, C1 and C2 are the circumferences at the ends of the segment, and h is the distance between them (segment length)

pain intensity

时间窗: up to twelve weeks

pain intensity will be measured by visual analogue scale

次要结局

未报告次要终点

研究者

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

Catherine Moanis Labib Botros

principle investigator

Cairo University

研究点 (2)

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