Effect of Focused Focused Extracorpeal Shock Wave on the Myo-Electrical and Nerve Root Function in Patients With Cervical Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Level of radiating pain
研究概览
简要总结
BACKGROUND: Upper limb nerve root dysfunction with increased active myofascial trigger point in upper trapezius is common problem in patients with cervical radiculopathy.
The purpose of this study was to evaluate the effect of Extracorpeal shock wave on the myo-electric and nerve function responses in patients with cervical radiculopathy.
详细描述
Randomized controlled clinical trial among Forty eight (48) patients with cervical radiculopathy.
They will be allocated randomly by sealed envelopes into two groups: Group (A): will receive a designed physical therapy program in addition to sham Extracorpeal shock wave on upper trapezius. Group (B): will receive Focused Extracorpeal shock wave on the active myofascial trigger points in upper trapezius in addition to the same physical therapy program as in group A.
Somatosensory evoked potential for upper limb median nerve will be applied using the Electromyography (EMG) device. Hand grip strength will be assessed using the handheld dynamometer (HHD) , Level of radiating pain will be assessed using the numeric rating scale , Pain and tenderness in upper trapezius muscle will be also assessed using Pressure pain threshold (PPT).
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 (Participant)
盲法说明
Patients participated will be masked about the type of intervention, where (GA) patients will receive PT program + sham shock wave on upper trapezius, while patients in (GB) will receive focused extracorpeal shock wave on the trigger points of upper trapezius in addition to the same PT program as (GA).
入排标准
- 年龄范围
- 36 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients suffer from unilateral discogenic cervical radiculopathy of lower cervical spine(C5-C6 and/ or C6-C7) as confirmed with MRI.
- •All patients suffer from pain and tenderness on active trigger points of the upper trapezius .
- •Age ranging from 36 to 46 years old.
- •Duration of symptoms more than 3 months to avoid acute stage of inflammation.
- •Side to side amplitude differences of 50% or more in DSSEPs measurement (Naguszewski et al.,2001)
排除标准
- •Posterior osteophytes
- •Spinal canal stenosis
- •Rheumatoid arthritis
- •Vestibular insufficiency
- •Osteoporosis
- •Any signs or symptoms of myelopathy
- •Any abnormalities of deep sensation
- •Associated pathologies of upper cervical region or the upper limb that may cause overlapping with clinical findings as referred pain from costotransverse joint, rotator cuff tendonitis, cervical rib syndrome and entrapment neuropathy.
结局指标
主要结局
Level of radiating pain
时间窗: Baseline Assessment and Immediately Post Treatment.
Numeric rating Scale (NRS) for pain will be used to assess level of pain radiating through the upper limb. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity . Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Amplitude of median nerve dermatomal somatosensory evoked potential
时间窗: Baseline Assessment and Immediately Post Treatment.
After the stimulation was performed and the traces were superimposed to ensure reproducibility, negative near field potential were detected and positive peak was detected to measure the peak to peak amplitude. This amplitude was measured. The distance between positive and negative peak , it is measures in millivolts (mV)
Distal Latency of median nerve dermatomal somatosensory evoked potential
时间窗: Baseline Assessment and Immediately Post Treatment.
Distal latency is defined as the interval between the stimulation of a compound muscle or selective dermatome and the observed response. It is measured in meter per second (m/s)
Pain Pressure Threshold on upper trapezius
时间窗: Baseline Assessment and Immediately Post Treatment.
Pain pressure Threshold (PPT) device will be used to detect tenderness and pain on the active myofascial trigger points on upper trapezius muscle. The 1-cm² rubber tip was applied perpendicularly over the myofascial trigger points and the power is switched on; a required pressure will be exerted on the site of myofascial trigger points by pressing the transducers firmly downwards. Measurements were recorded in kilograms of pressure per square centimeter (kg/cm\^2).
Hand grip Strength
时间窗: Baseline Assessment and Immediately Post Treatment.
Jamar hydraulic hand dynamometer will be used, it is a quantitative and an objective measure of the isometric muscular strength of the hand grip. It is a portable dynamometer used as a valid and reliable tool to reflect the upper limb strength. This instrument is scored using force production in kilograms (0-90) or pounds (0-200). Maximum grip was the mean of three trials. For each patient the both sides were assessed before treatment to collect the normative value for each patient. Mean of Maximum grip was compared pre and post treatment for each patient
次要结局
未报告次要终点
研究者
Engy Badreldin Saleh Moustafa, PhD
Dr.
Cairo University