Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Limb volume
研究概览
简要总结
Sixty eight female patients who had symptoms of carpal tunnel syndromesuch as wrist pain or numbness and paraesthesia and had lymphedema of an upper extremity.Their ages will be ranged from 40 to 60 years. The participants will be selected from Out Patient clinic of Faculty of Physical Therapy, Cairo University and randomly distributed into two equal groups.Duration of treatment for 4weeks.All subjects signed an informed consent form, and the rights of subjects were protected.
详细描述
In this study the patients will be randomly assigned into two equal groups(34 patients for each group)Group A (experimental group):This group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks. Group B (control group):
This group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All participants could be considered and enrolled if they conformed to the diagnosis of CTS, with clinical symptoms for at least 3 months.
- •The clinical symptoms and signs for the diagnosis of CTS were as follows:
- •Paresthesias and painful swelling with weakness of the affected hand, exacerbated while sleeping or by repetitive use of the wrist, which would be relieved by shaking the hand with postural change.
- •Sensory loss with numbness in the regions of the hand innervated by the median nerve;
- •Impaired motor function with atrophy of the median nerve-innervated thenar muscles.
- •Positive Tinel's sign.
- •The subject selection will be according to the following criteria:
- •Female patient their age range between 40-60 years.
- •Symptoms of CTS as pain, tingling sensation for at least 3 months.
- •Unilateral or bilateral Lymphedema following mastectomy
- •All patients enrolled to the study will have their informed consent.
排除标准
- •The potential participants will be excluded if they meet one of the following criteria:
- •Local infections at the hand level.
- •Patients with prior medical histories of cardiac arrhythmias.
- •Patient with venous thrombosis.
- •Areas of skin with lesions and impaired sensation
- •Other diseases that cause significant swelling.
- •During pregnancy and breastfeeding.
结局指标
主要结局
Limb volume
时间窗: 4weeks
Upper limb volumes were calculated from circumference measurements taken at 5cm intervals from the dorsum of the wrist to the axilla. Volume was calculated from circumference using the established formula
Visual analogue scale (VAS)
时间窗: 4weeks
The VAS uses a straight 10-centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level within the last 24 hours.
Boston Carpal Tunnel Questionnaire (BCTQ)
时间窗: 4weeks
The BCTQ is used to evaluate symptom severity and dysfunction in patients with CTS .It contains 2 measurement scales: a symptom severity scale (BCTQ-S) and a functional status scale (BCTQ-F). The BCTQ-S uses 11 questions to evaluate the intensity and frequency of pain, numbness, weakness and loss of dexterity on a five-point scale ranging from 1 (no symptoms) to 5 (severe symptoms). The results are interpreted as the average scores of the 11 questions. The BCTQ-F has 8 questions to evaluate the level of difficulty in performing daily tasks, each rated on a five-point scale ranging from 1 (no difficulty) to 5 (cannot do at all due to hand or wrist symptoms). The results are interpreted as the average scores of the 8 questions
Nerve conduction studies
时间窗: 4weeks
For assessing the motor response, the recorder electrode on abductor pollicis brevis muscle and median nerve was stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode , and the distal latency was recorded. Regarding the sensory response, the recorder was fastened on the third finger, and stimulator electrode was placed 14 cm proximal to the recorder and stimulated median nerve at wrist and at palm region, then distal latency was recorded. If only the SNAP distal latency was long, patient had mild CTS, but if both SNAP and CMAP distal latency were long and denervation was not observed in electromyography of APB, it was moderate CTS
次要结局
未报告次要终点
研究者
Shahira Sami
Principle investigator
Cairo University