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临床试验/CTRI/2024/07/070786
CTRI/2024/07/070786已完成不适用

Comparative Efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with Chronic Non Specific Low Back Pain a randomized clinical trial

Rohini Kusum Lakra1 个研究点 分布在 1 个国家入组 34 人开始时间: 2024年7月29日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
1. Pain intensity [Numerical Pain Rating Scale (NPRS)].

研究概览

简要总结

PURPOSE OF THE STUDY: There are many studies available on the efficacy of Interferential Therapy on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain. However very few studies have been conducted on Microcurrent in the treatment of chronic non- specific low back pain. To the best of our knowledge there are no studies available which compared the efficacy of Interferential Therapy and Microcurrent in chronic non- specific low back pain.

So, the purpose of this study is to compare the efficacy of Interferential Therapy and Microcurrent along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain.

AIM:

To find out the comparative efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain**.**

OBJECTIVES:

  1. To find out the efficacy of Interferential Therapy along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain**.** 2. To find out the efficacy of Microcurrent along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain**.** 3. To compare the efficacy of Interferential Therapy along with Supervised Exercise and Microcurrent along with Supervised Exercise on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain**.**

HYPOTHESIS:

NULL HYPOTHESIS (H0):There is no statistically significant difference between the efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain.

ALTERNATIVE HYPOTHESIS (H1): There is statistically significant difference between the efficacy of Interferential Therapy and Microcurrent on Pain, Range of Motion and Function in subjects with chronic non-specific low back pain. PROCEDURE: After obtaining the Approval from the Institutional Ethical Committee (IEC), all the subjects with Low Back Pain referred from the Assessment Clinic of National Institute for Locomotor Disabilities (Divyangjan) [NILD] will be approached, assessed and screened according to inclusion and exclusion criteria. Subjects meeting the exclusion criteria will not be included. Those meeting the inclusion criteria will be explained in detail about the aim and procedure of the study in their most communicable language. Written informed consent in their preferred language will be taken from the subjects agreeing to participate.

The subjects will be divided into two groups with a minimum of 17 subjects in each group, by block randomization method. The demographic data and outcome measures for Pain using the ‘Numerical Pain Rating Scale, Range of Motion by ‘Modified- Modified Schober’s test’ and Function by ‘Oswestry Disability Index’ will be collected at baseline as pre intervention data and at the end of 10 sessions as post intervention data.

Group - A: All the subjects in Group A (n = 17) will be treated with Interferential Therapy for 10 minutes followed by Supervised Exercise Program for 10 sessions.

Group - B: All the subjects in Group B (n = 17) will be treated with Microcurrent for 20 minutes followed by Supervised Exercise Program for 10 sessions. Home Exercise Program and Ergonomic Care will be explained to all the subjects in both groups. Rescue medications duly prescribed by physician will be continued along with the Physiotherapeutic approach in both the groups during the study.

研究设计

研究类型
干预性
分配方式
随机
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Subjects age between 20 to 45 years.3 2.
  • Both male and female subjects.
  • Pain in the area between 12th ribs and L5 vertebra.2 4.
  • Subjects with Low Back Pain duration of more than 3 months.6 5.
  • Pain intensity according to Numerical Pain Rating Scale (NPRS) from 3-8.

排除标准

  • Cases of unilateral or bilateral radiating pain (Radiculopathy, Sciatica).2 2.
  • Musculoskeletal conditions like scoliosis, spondylosis, spondylolisthesis, limb length discrepancy etc.3,5 3.
  • History of trauma, fracture of spine, lower limb, spinal surgery and metal implant etc.
  • Rheumatological disorders like Rheumatoid arthritis, Ankylosing spondylitis etc.
  • Neurological conditions like Spinal cord injury, Developmental disorders and congenital diseases like spina bifida etc.
  • Cases with implanted pacemaker / cardiac disorders.
  • Pregnancy and other diagnosed gynaecological disorders etc.3 9.
  • Localised skin infections / lesions in lumbar spine.

结局指标

主要结局

1. Pain intensity [Numerical Pain Rating Scale (NPRS)].

时间窗: 2 times – on day 0 and after 2 weeks of | intervention

2. Lumbar Flexion-Extension ROM [Modified -Modified Schober’s Test (MMST)].

时间窗: 2 times – on day 0 and after 2 weeks of | intervention

3. Function [Oswestry Disability Index (ODI)].

时间窗: 2 times – on day 0 and after 2 weeks of | intervention

次要结局

未报告次要终点

研究者

发起方
Rohini Kusum Lakra
申办方类型
Other [Self]
责任方
主要研究者
主要研究者

Rohini Kusum Lakra

Department of Physiotherapy

研究点 (1)

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标识符

CTRI 编号
CTRI/2024/07/070786

日期

研究完成日期
(去年)
最近更新
(2年前)

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