The Effects of Combined Lumbar Traction and Repeated Back Extension Exercise on H-Reflex, Pain, and Disability in Patients With Lumbosacral Radiculopathy
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
- Soleus H-reflex latency
研究概览
简要总结
The aim of the study is to investigate the effect of performing combined lumbar traction and repeated back extension exercise (McKenzie) on soleus H-reflex, pain, and disability in patients with lumbosacral radiculopathy. The main question that it aims to answer is:
Does the combination of lumbar traction and back extension exercise (McKenzie) improves soleus H-reflex, pain, and function in patient with lumbosacral radiculopathy? participants will be randomized into 2 groups: one group will include repeated back extension exercise (McKenzie Approach) without mechanical traction and the other group will include the same but in combination with mechanical traction.
详细描述
Repeated back extension exercises as described by McKenzie from prone position has been widely suggested for patients with lumbosacral radiculopathy (LSR). It has been reported to decrease radicular symptoms which could be due to the decompression effect of this exercise on the compromised nerve root. Moreover, mechanical traction have a debatable effect on lumbosacral patients with little evidence that supports its effectiveness. Thus, the investigators hypothesize that performing a combination of lumbar traction and repeated back extension exercise will improve the soleus H-reflex, pain, and function of lumbosacral radiculopathy patients.
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
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with chronic unilateral lumbosacral radiculopathy (more than 3 months duration)
- •Age:35- 60 years
- •Both male and female
- •People with L5-S1 postero-lateral disc herniation or protrusion.
- •people with positive straight leg raise
排除标准
- •Subjects with lumbosacral Surgery.
- •Subjects with stenosis or scoliosis.
- •Subjects with cardiac problem or cancer.
- •Subjects with peripheral neuropathy.
- •Subjects with upper motor neuron injury.
研究组 & 干预措施
repeated back extension exercise (McKenzie)
Repeated back extension exercise as described by McKenzie in prone position was performed of three sets of ten repetitions with one minute rest between the sets. The patient was asked to reach the maximum extension possible in all attempts and maintain this position for one second. The intervention was done 3 times per week for 6 weeks.
干预措施: Repeated back extension exercise (McKenzie) (Other)
Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)
Participants allocated to mechanical lumbar traction received the McKenzie approach described above in combination with mechanical lumbar traction. The traction was applied using a 3D ActiveTrac table which is a motorized split table. Participants were placed in prone position and static traction was applied for 15 minutes at an intensity of 40% to 60% of the participant's body weight. At the end of traction intervention, participants continued with the McKenzie repeated back extension exercise intervention. The intervention was done 3 times per week for 6 weeks.
干预措施: Repeated back extension exercise (McKenzie) (Other)
Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)
Participants allocated to mechanical lumbar traction received the McKenzie approach described above in combination with mechanical lumbar traction. The traction was applied using a 3D ActiveTrac table which is a motorized split table. Participants were placed in prone position and static traction was applied for 15 minutes at an intensity of 40% to 60% of the participant's body weight. At the end of traction intervention, participants continued with the McKenzie repeated back extension exercise intervention. The intervention was done 3 times per week for 6 weeks.
干预措施: Mechanical traction (Device)
结局指标
主要结局
Soleus H-reflex latency
时间窗: At baseline and 6 weeks
latency in milliseconds (ms)
Soleus H-reflex amplitude
时间窗: At baseline and 6 weeks
amplitude in millivolts (mV)
次要结局
- Numerical Pain Intensity Scale(At baseline and 6 weeks)
- Oswestry Disability Index (ODI)(At baseline and 6 weeks)
研究者
Ahmed ElMelhat
Principal investigator
Cairo University