Randomized Controlled Trial of Effectiveness of Neural Mobilization in the Management of Chronic Low Back Pain With Radiculopathy.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Pain is being assessed using NPRS
研究概览
简要总结
This study is to determine the effectiveness of Neural mobilization(NM) technique compared with lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT) in the physical therapy management of chronic low back pain (CLBP) with radiculopathy. Subjects will be randomly assigned into two groups. Group A (NM, LSE and rESWT) and Group B (LSE and rESWT).
详细描述
Randomized clinical control trail will be conducted in the North West area of Saudi Arabia.
Patients diagnosed to have CLBP with radiculopathy at three different hospitals in Saudi Arabia will be recruited for this study.
Participants will be randomly assigned into treatment or control group. Before starting of the study, the author will designe the treatment and control group treatment program and instructed the treating physiotherapists in their implementation. An ethical approval was approved by the ethics committee of the University of Tabuk- Saudi Arabia. Participants in each group will receive 12 treatment sessions of 45 minutes each, 2 days a week for 6 consecutive weeks.
For each group, a menu of a lumbar stabilization program was designed. This program included 8 levels of exercise ( single leg knee to chest stretch, double leg knee to chest, supine piriformis stretch, supine hamstring stretch, lower trunk rotation stretch, lumbar rotation stretch, pelvic tilt, pelivic tilt with alternative legs). Exercises were tailored for each individual ability and, if possible, progressed at each session which would last approximately 30 minutes. Each single exercise was repeated many times based on the patient's clinical condition. All sessions were provided by physiotherapists. After finishing of session of lumbar stabilization program, a shock wave therapy was applied for each participant in a prone position over the region of low back pain (Figure 2 ).
Only participants in the treatment group were receive neural mobilization technique. This includes the following: sciatic neural mobilization technique (Figure 3), slump neural mobilization technique (Figure 4) and self neural mobilization (Figure 5 ).
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lower back pain should be Lower than 5 on the Visual Analogue Scale,
- •> 18 years,
- •Not taken physical therapy treatment in the past 6 months period,
- •No previous surgery, such as structural anomalies, spinal cord compressions, severe instabilities, severe osteoporosis, acute infections, severe cardiovascular or metabolic diseases,
- •A body mass index less than 30kg/m2.
排除标准
- •Pain with a score above 5 on the Visual Analogue Scale (VAS),
- •≤ 18 years,
- •Had physical therapy treatment in the past 6 months period,
- •Had undergone previous surgery, such as structural anomalies, spinal cord compressions, severe instabilities, severe osteoporosis, acute infections, severe cardiovascular or metabolic diseases,
- •A body mass index above 30kg/m2.
研究组 & 干预措施
Experimental group
Neural mobilization (NM), lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT)
干预措施: Exercise, manual therapy (Other)
Control group
lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT)
干预措施: Exercise, manual therapy (Other)
结局指标
主要结局
Change in Pain is being assessed using NPRS
时间窗: baseline, 3 weeks and 6 weeks
Pain was assessed by using NPRS, where 0 represented no pain and 10 represented the worst pain possible, to indicate the intensity of pain in the lower back (Jensen et al., 1994).
Change in Disability is being assessed using the Modified Oswestry Disability Questionnaire
时间窗: baseline, 3 weeks and 6 weeks
Disability was measured by using the Modified Oswestry Disability Questionnaire (MODQ) which is a self-rating questionnaire used to evaluate functional physical disability (Rajfur, et al., 2017).
Change in Lumbar flexion range of motion is being assessed using modified Schober method
时间窗: baseline, 3 weeks and 6 weeks
Lumbar flexion range of motion was measured by using modified Schober method (Philadelphia Panel Members, 2001).
次要结局
未报告次要终点
研究者
Salem F Alatawi
Clinical Professor
University of Tabuk
