Effect of High Power Laser Therapy on Pain and Electrophysiological Study in Cervical Radiculopathy Patients: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- F wave
研究概览
简要总结
The goal of this clinical trial is :
To determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy.
The main question it aims to answer :
Is there a significant effect of high power laser therapy (HPLT) on pain and electrophysiological study in patients with cervical radiculopathy?
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 will randomly assigned into two equal matched groups;
- group A (study group) N=10: this group will receive high power laser therapy (HPLT) for 8 minutes in addition to selected physical therapy program
- group B (control group) N=10: this group will receive the same selected physical therapy program only (hot pack, US for 5 min, exercise for 20 min) for 8 session.
All patients will attend the physical therapy clinic two times weekly for 4 weeks.
The evaluation was done by nerve conduction study (NCS) and needle electromyography (EMG) before and after the treatment in addition to visual analogue scale (VAS).
HYPOTHESES:
Null hypothesis: There is no significant effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy.
详细描述
This current study will be designed to determine the effect of high power laser therapy on pain and electrophysiological study in patients with cervical radiculopathy. This study will be carried out at outpatient clinic of Faculty of Physical Therapy, Cairo University.
Twenty patients with cervical radiculopathy caused by disc prolapse at the level of C5 - C6 or C6 - C7 cervical radiculopathy will be selected from outpatient clinic of Faculty of Physical Therapy, Cairo University and outpatient clinic of Qasr El- Aini Hospitals.
On approval to participate in the study, all subjects will sign an informed consent form after receiving full information on the purpose of study, procedure, possible benefits, privacy and use of data, and their rights to withdraw from the study whenever they want.
Sample size:
Sample size calculation is performed using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) and revealed that the required sample size for this study is N=20.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty patients with unilateral cervical radiculopathy due to disc prolapse at the level of C5 - C6 or C6 - C
- •Age ranges from 30 to 50 years.
- •Patients will be both sexes.
- •Patients will be diagnosed by clinical and radiological examination.
- •Presence of sensory changes as pain and paresthesia (numbness, tingling, burning) in the upper extremity.
- •Pain severity should be moderate or severe.
- •Reporting a minimum pain score of 4 on a 10-point Visual Analogue Scale (VAS).
- •Duration of pain ranges from (3-12) months.
排除标准
- •Diabetic patient.
- •Patients with peripheral neuropathy or entrapment syndrome.
- •Previous cervical or shoulder surgery.
- •Fracture of the bones of upper extremity.
- •Major neurological condition (e.g., stroke, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
结局指标
主要结局
F wave
时间窗: before and after one month of treatment
for both median and ulnar nerves of both upper extremities
pain severity
时间窗: before and after one month of treatment
using a 0-10 cm visual analog scale (VAS). Patients were asked to make a handwritten mark on a 100 mm line (10cm). This line represents a continuum between no pain or discomfort (zero), to the worst pain (10) that the patient could feel. The measure was taken by a ruler from the starting point of the scale to the mark the patient scored in millimeters. The results were interpreted as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm), (Jensen 2003). Patients should have moderate to severe neck pain to be included in the study. The pain intensity was recorded before and after the study.
次要结局
- nerve conduction studies (NCS)(before and after one month of treatment)
- electromyography (EMG)(before and after one month of treatment)
研究者
Dina Ahmed Sherif Sherif
Physiotherapist at Al-Minshawy General Hospital
Cairo University