Effect of Extracorporeal Shock Wave Therapy on Intercostobrachial Neuralgia Post Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Range of Motion
研究概览
简要总结
PURPOSE: The main objective of the study is:
to evaluate the therapeutic effect of ESWT on intercostobrachial neuralgia post-mastectomy.
BACKGROUND:
Intercostobrachial neuralgia post-mastectomy is thought to develop from surgical damage to the intercostobrachial nerve, this nerve is injured in 80-100 % of mastectomy patients who undergo axillary lymph nodes dissection.
Pain that is localized in the axilla, medial upper arm, breast, and/or chest wall significantly affects the patient's mood, everyday activities, and social functioning, causing a heavy economic burden on healthcare systems. If poorly treated, patients may develop an immobilized arm, which can lead to severe lymphedema, frozen shoulder syndrome, and complex regional pain syndrome.
HYPOTHESES:
It will be hypothesized that:
Shock wave therapy has no effect in improving intercostobrachial neuralgia post-mastectomy.
详细描述
Sixty female patients aged 40 and 65 years, suffering from intercostobrachial neuralgia after modified radical mastectomy will be selected from the National Cancer Institute, Cairo, Egypt. They will be randomly assigned into two equal groups, thirty patients each (study group and control group). The intervention in the study group will be conducted for 8 weeks.
Inclusive criteria :
The subject selection will be according to the following criteria:
- The age range will be from 40 to 65 years.
- All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy.
- All patients suffering from moderate or severe pain of burning, tingling, numbness, and electric nature persisting for 3-5 months following mastectomy, in the anterior chest wall, axilla, and upper medial arm with altered sensitivity of the skin in the painful area.
- All patients had unilateral mild to moderate lymphedema (circumference difference 4 cm).
- All patients will have completed their chemotherapy or radiotherapy treatment.
- All patients enrolled in the study will have their informed consent.
Exclusive criteria:
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age range will be from 40 to 65 years.
- •All patients will be female patients suffering from intercostobrachial neuralgia after unilateral modified radical mastectomy.
- •All patients suffering from moderate or severe pain of burning, tingling, numbness, and electric nature persisting for 3-5 months following mastectomy, in the anterior chest wall, axilla, upper medial arm with altered sensitivity of the skin in the painful area.
- •All patients had unilateral mild to moderate lymphedema (circumference difference 4 cm).
- •All patients will have completed their chemotherapy or radiotherapy treatment.
- •All patients enrolled to the study will have their informed consent.
排除标准
- •Current metastases.
- •Continuing radiotherapy or chemotherapy.
- •History of allergy to coupling agent.
- •Chronic inflammatory diseases and cellulitis.
- •Venous thrombosis.
- •Local infections.
- •Patients with diabetes mellitus (neuritis).
- •Open skin lesions in the painful area.
- •Other causes of arm pain (brachial plexus neuropathy due to radiotherapy, cervical radiculopathy, peri-capsulitis of shoulder joint).
结局指标
主要结局
Range of Motion
时间窗: Measurements will be taken at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).
Shoulder Flexion and Abduction will be assessed from supine position
Neuropathic Pain
时间窗: at baseline (pre-treatment), after 4 weeks and after 8 weeks (post-treatment).
The Visual Analog Scale (VAS) will be used for assessing and quantifying pain exhibited by the patients.
次要结局
未报告次要终点
研究者
Rehab Abutaleb
Faculty of Physical therapy, Department Physical Therapy for Surgery and Burn
Cairo University