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临床试验/CTRI/2024/09/073251
CTRI/2024/09/073251进行中(未招募)2 期

Comparative Efficacy of Motor control exercise and surface EMG guided exercises in low back pain with lumbar radiculopathy - A single blinded Randomized Clinical Trial

Nopany Institute of Healthcare Studies1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月29日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
I. Pain

研究概览

简要总结

Pain, Muscle weakness, and postural instability are very common causes of long-term disability related to low back pain with Lumbar radiculopathy worldwide. The incidence of low back pain is estimated between 13% to 31%, and among them,12%-40% of patients with low back pain experience radicular symptoms. Improvement of postural stability and motor control are important predictor for improving the quality of life and functional independence among patients with low back pain with Lumbar radiculopathy. Various approaches are implemented in physiotherapy to improve the patient’s symptoms with low back pain and Lumbar radiculopathy. Motor control and EMG-guided exercises greatly enhance postural control and functional independence by enhancing muscle strength and awareness of muscle actions through audio-visual feedback.

Purpose of study : The purpose of the study is to find out the efficacy of motor control exercise (MCE) and surface EMG-guided exercise to reduce disability and improve the quality of life in patients with low back pain with Lumbar radiculopathy and compare the efficacy of these 2 different techniques.

Methodology: Patients who were referred with complaints of low back pain with radiculopathy were assessed for eligibility. A brief screening of patients was performed using an SLR (straight leg raise) test to confirm a lumbar disc herniation. According to the inclusion-exclusion criteria, 50 patients were selected, among them 16 patients were excluded by not meeting the criteria (n=9), and declined to participate(n= 7). 34 patients were randomly divided into two groups (n=17) to compare the efficacy of motor control exercise and surface EMG-guided exercise. 6 patients from Group B discontinued from mid-intervention, Group A (n= 17) was received motor control exercise, and Group B (n=11) received EMG-guided exercise. Treatment was provided for 3 sessions /week for a total of 4 weeks.

Statistical Analysis: The statistical analysis was conducted using SPSS software version 30.0. The primary analysis used descriptive statistics to analyse the demographic data. Homogeneity of the groups was checked using the Shapiro-Wilk test. Pre (baseline) and post (after 4 weeks) intervention data. Student t-tests were used for the inter-group and within-group data analysis. The level of significance was considered at p<0.05.

Result: The results of the within-group analysis showed significant results with a significant mean difference (p<0.05) in all the outcomes of both Group A and Group B, except for hip adductor strength in Group B. Between-group comparisons revealed no significant differences with a mean difference (p>0.05) between Group A and Group B. Both interventions demonstrated that 4 weeks of intervention results in a similar level of effectiveness in managing low back pain with lumbar radiculopathy. Therefore, the null hypothesis is accepted in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • I.Patients experiencing lower back pain that radiates unilaterally below the knee II.The patients who have already been assessed and diagnosed by a physician by clinical examination and radiological investigations as low back pain with radiculopathy.
  • Positive response of Straight Leg Raise (SLR) with symptom reproduction between 40 to 70 degrees.
  • Presence of at least one neurological sign such as motor impairments in dermatomal or sensory changes in myotomal pattern according to nerve roots.

排除标准

  • I.Pain only up to the buttock region II.
  • Patients with cardio-thoracic conditions III.Any recent lower limb peripheral nerve repairs IV.
  • Indication of Surgical intervention, for example, absence of reflexes, muscle atrophy, and signs compatible with lumbar myelopathy, V.
  • Diabetic neuropathy VI.Pregnancy or any gynecological problem.

结局指标

主要结局

I. Pain

时间窗: 4 weeks

II.Radicular pain

时间窗: 4 weeks

III. Muscle strength

时间窗: 4 weeks

IV. Range of motion

时间窗: 4 weeks

V. Disability

时间窗: 4 weeks

次要结局

  • I. Quality of life(4 weeks)

研究者

发起方
Nopany Institute of Healthcare Studies
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Shelina Jahan Tithi

Nopany Institute of Healthcare Studies

研究点 (1)

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