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临床试验/CTRI/2025/02/080878
CTRI/2025/02/080878尚未招募不适用

Effect of spinal Mobilization with limb movement (SMWLM) on pain, nerve conduction velocity of common peroneal nerve, neurogenic claudication, range of motion of lumbar spine and functional activities in patients with lumbar canal stenosis

Kajal Yadav1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年2月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
pain, range of motion of lumbar spine, neurogenic claudication, nerve conduction velocity of common peroneal nerve

研究概览

简要总结

Low back pain (LBP) is a widespread issue, with Lumbar Spinal Stenosis (LSS) being a key contributor, affecting around 20% of LBP patients. LSS is a condition where the spinal canal narrows, leading to nerve compression, pain, and sensory disturbances, particularly in the lower back and legs, and is common in older adults. It is diagnosed using clinical assessments and imaging techniques like MRI or CT scans. There are two types of stenosis: central and lateral, each caused by different structural changes in the spine. Electromyography (EMG) and Nerve Conduction Studies (NCS) are often used to evaluate nerve damage in these patients. Spinal mobilization with leg movement (SMWLM), a technique involving spinal mobilization combined with leg movement, is suggested for treating leg pain from low back issues, but no studies have investigated its effect on LSS specifically. This study aims to explore the impact of SMWLM on patients with lumbar canal stenosis.

Hypothesis:

Null Hypothesis

·         H01: There will be no significant effect of spinal mobilization with limb movement on pain in patients with lumbar canal stenosis.

•      H02: There will be no significant effect of spinal mobilization with limb movement on nerve conduction velocity in patients with lumbar canal stenosis.

•      H03:There will be no significant effect of spinal mobilization with limb movement on neurogenic claudication in patients with lumbar canal stenosis.

•      H04: There will be no significant effect of spinal mobilization with limb movement on nerve range of lumbar spine in patients with lumbar canal stenosis

•      H05: There will be no significant effect of spinal mobilization with limb movement on functional activities in patients with lumbar canal stenosis.

Alternate Hypothesis

·         H1: There will be any significant effect of spinal mobilization with limb movement on pain in patients with lumbar canal stenosis.

•      H12: There will be any significant effect of spinal mobilization with limb movement on nerve conduction velocity in patients with lumbar canal stenosis.

•      H13: There will be any significant effect of spinal mobilization with limb movement on neurogenic claudication in patients with lumbar canal stenosis.

•      H14: There will be any significant effect of spinal mobilization with limb movement on range of lumbar spine in patients with lumbar canal stenosis.

•      H15: There will be any significant effect of spinal mobilization with limb movement on functional activities in patients with lumbar canal stenosis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Pre-diagnosed patients with lumbar canal stenosis 2.Patients with their MRI suggesting LSS AP diameter less than 12mm & lateral recess diameter less than 7mm.
  • 3.Patients presenting with Neurogenic Claudication include pain in the buttock, groin, and anterior thigh, which radiates to the posterior part of the leg to the feet and leg symptoms like cramps, fatigue, heaviness, weakness and/or paraesthesia on the basis of assessment.

排除标准

  • Any previous history of spinal surgeries like laminectomy or spinal fractures.
  • Patients with cardiac or pulmonary disease.
  • Patients with any kind of spinal deformity (hyperlordosis, kyphosis, scoliosis) Vascular claudication
  • Any predisposing disease such as cancer, diabetes, renal failure, tumor, pregnancy.

结局指标

主要结局

pain, range of motion of lumbar spine, neurogenic claudication, nerve conduction velocity of common peroneal nerve

时间窗: Day 1 assessment after 2 weeks assessment

次要结局

  • Functional activities(Day 1 assessment after 2 weeks assessment)

研究者

发起方
Kajal Yadav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kajal Yadav

PG Student

研究点 (1)

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