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临床试验/CTRI/2020/06/025813
CTRI/2020/06/025813已完成1 期

Effect Of Kinetic Control And Lumbar Stabilization Exercises In Patients With Mechanical Low Back Pain:A Comparative Study

Roopa Desai1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年6月15日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
1.Assessing Lumbar Core Strength by Pressure Biofeedback.

研究概览

简要总结

This study is an experimental,single blinded,parallel group study comparing the effect of Kinetic Control,Lumbar Stabilization Exercises and a combination of Kinetic Control and Lumbar Stabilization Exercises on pain,flexibility,Strength,muscle Activation and functional disability in subjects with Mechanical Low Back Pain.The study will be conducted in Dr.D.Y. Patil  Physiotherapy Out Patient Department Pune ,India. The Primary Outcome measures will be Pressure Biofeedback to assess core muscle strength and Activation of Transversus Abdominis and Multifidus by EMG.The secondary Outcome measures include Pain that will be measured by NPRS , Lumbar Range of Motion measured by Modified Modified Schobers test and Rolland Morris Disability Questionnaire,that consists of 24 Questions that focus on regular activities of daily living.All outcome measures will be assessed prior to the treatment,at the end of 4th week and at the end of 8th week.

  1. August 2020 - Conducted Pilot Study and calculated sample size taking 10% dropout rates that came upto 75 patients.

  2. Completed SWAYAM MOOC Course on Academic Writing 11th January 2021 to 25th April 2021.

  3. May 2021 - Data Collection in process

  4. November 2021 - Data collection in process

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
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Individuals with Chronic Mechanical Low Back Pain,subjects with mild to moderate pain on NPRS,Age group between 20 to 40 years,both genders.

排除标准

  • History of Spine Surgery,Recent Lower Limb Surgery,Recent Trauma to Back and Lower Extremities,diagnosed pathological conditions related to Low Back Pain,diagnosed cases of Rheumatoid Arthritis,Ankylosing Spondylitis,Spinal deformities,Neurological diseases,History of Cardiovascular diseases,Stroke,Pregnancy,history of radiating pain to Lower Extremities,BMI more than 30kgs per m2,Subjects taking any other forms of treatment for Low Back Pain.

结局指标

主要结局

1.Assessing Lumbar Core Strength by Pressure Biofeedback.

时间窗: 1.Assessing Lumbar Core Strength by Pressure Biofeedback after 4 and 8 weeks. | 2.Activation of Transversus Abdominis and Multifidus by EMG after 4 and 8 weeks.

2.Activation of Transversus Abdominis and Multifidus by EMG.

时间窗: 1.Assessing Lumbar Core Strength by Pressure Biofeedback after 4 and 8 weeks. | 2.Activation of Transversus Abdominis and Multifidus by EMG after 4 and 8 weeks.

次要结局

  • 1.Numerical Pain Rating Scale(NPRS)(2.Modified-Modified Schobers Test .)
  • Rolland Morris Disability Questionnaire(It has 24 Questions that focus on regular activities of daily living that will be assessed after 4 and 8 weeks.)

研究者

发起方
Roopa Desai
申办方类型
Other [self]

研究点 (1)

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