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CTRI Number  CTRI/2021/03/032195 [Registered on: 22/03/2021] Trial Registered Prospectively
Last Modified On: 15/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between effect of core strengthening, spinal flexibility and mobility exercises in lumbar canal stenosis patients 
Scientific Title of Study   Comparison between effect of dynamic neuromuscular stabilisation (dns) and canal enlargement exercises in individuals with lumbar canal stenosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deeksha Sharma 
Designation  PG student 
Affiliation  Punjabi University, Patiala 
Address  Department of Physiotherapy, Punjabi University, Patiala, Punjab

Patiala
PUNJAB
147001
India 
Phone  8146966176  
Fax    
Email  deeksha0075sharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Narkeesh Arumugam 
Designation  Head of the Department 
Affiliation  Punjabi University, Patiala 
Address  Department of Physiotherapy, Punjabi University, Patiala
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147001
India 
Phone  9417802662  
Fax    
Email  narkeesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deeksha Sharma 
Designation  PG student 
Affiliation  Punjabi University, Patiala 
Address  Department of Physiotherapy, Punjabi University, Patiala

Patiala
PUNJAB
147001
India 
Phone  8146966176  
Fax    
Email  deeksha0075sharma@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Punjabi University, Patiala 
 
Primary Sponsor  
Name  Narkeesh Arumugam HOD  
Address  Punjabi University Patiala, Punjab. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deeksha Sharma  Punjabi University, Patiala  Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB 
8146966176

deeksha0075sharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Eperimental group 2  Canal enlargement exercises, Conventional physiotherapy treatment, class-IV LASER Treatment session will be for 45 minutes, No drugs will be given to patrticipants 
Intervention  Experimental group  DNS exercises along with conventional physiotherapy treatment, Class-IV LASER Treatment session will be for 45 minutes No drugs will be given to patient 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals with age group 20-60 years
2. MRI findings with lumbar canal spinal stenosis
3. Pain in lumbopelvic region and in lower extremities
4. Individuals diagnosed with lumbar canal spinal stenosis
 
 
ExclusionCriteria 
Details  1. Previous lumbar spinal surgery, Recent surgical cases
2. H/O spinal tumors, infections, lumbar vertebra fracture
3. Structural stenosis
4. Non cooperative individuals
5. Pregnancy
•Individuals with severe vascular, pulmonary or coronary artery diseases
•Individuals with Psychological disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Oswestry Low Back Pain Disability Questionnaire, outcome Score,   0 session
5session
10 session 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale , The Neurogenic Claudication scale  Day 0
Day5
Day10 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   29/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BACKGROUND

Lumbar spinal stenosis is degenerative condition of the spine and major cause of low back pain. The prevalence of the lumbar canal stenosis is increasing progressively, majority of population from young age group to old age group is affected with low back pain. The various treatment approaches is available for lumbar spinal stenosis such as medical treatment, Epidural corticosteroid, spinal surgery, physiotherapy treatment.The treatment for lumbar canal stenosis is mostly surgical. Few researchers introduce non surgical methods which help in better outcome. One of new method developed by Prague School of Rehabilitation is Dynamic Neuromuscular Stabilization (DNS) approach which will produce eccentric contraction of transverse abdominis muscle and increase intraabdominal pressure. Intra-abdominal pressure & integrated spinal stabilizing system provide functional spinal stability which will help in better outcome in individuals with lumbar canal stenosis.

OBJECTIVE

To find the effectiveness of Dynamic Neuromuscular Stabilization and canal enlargement exercises in lumbar canal Stenosis.

METHODOLOGY

Nature of study

The present study will be Randomized Control Trial (RCT) in nature in which Comparison between effect of Dynamic Neuromuscular Stabilization and Canal enlargement exercises in individuals with lumbar canal stenosis will be seen

Sampling Method

Purposive Sampling will be done.

Sample Size

A total of 20 subjects will be selected for the study and the same will be equally allocated into the both groups.

 

Sampling Criteria

Inclusion Criteria

Exclusion Criteria

·        Individuals with age group 20-60 years

·        MRI findings with lumbar canal spinal stenosis

·        Pain in lumbopelvic region and in lower extremities

·        Individuals diagnosed with lumbar canal spinal stenosis

·        Previous lumbar spinal surgery, Recent surgical cases

·        H/O spinal tumors, infections, lumbar vertebra fracture

·        Structural stenosis

·        Non cooperative individuals

·        Pregnancy

·        Individuals with severe vascular, pulmonary or coronary artery diseases

·        Individuals with Psychological disorders

 

Outcome Measures: Oswestry Low Back Pain Disability Questionnaire, Numerical Pain Rating Scale , The Neurogenic Claudication outcome Score, H-reflex

Procedure

Participants will be selected from the population on the basis of inclusion and exclusion criteria. Participants will be explained about the nature of the study and consent will be signed by the participants. Assessment will be done by using Oswestry Low Back Pain Disability Questionnaire, Numerical Pain Rating Scale and The Neurogenic Claudication outcome Score. The treatment protocol of 45 min/day for 5 days a week for a period of 3 weeks will be given.

Step 1:

The participants will be asked to wear comfortable clothing and to remove metallic ornament during treatment session. The participants will be made to lie supine comfortably on couch. The treatment will be started.

Step 2:

A proper assessment will be taken on Day 0, Day 5, Day 10  Oswestry Low Back Pain Disability Questionnaire will be filled by the patient followed by, The Neurogenic Claudication outcome  Score, Numerical Pain Rating Scale, H-reflex, reading will be taken in data collection form.

For the Experimental group (A)

Step 3:

               Participants will treated with Dynamic Neuromuscular Stabilization exercises, TENS, Hot fomentation, Static bicycling, balance training, Class-IV LASER

Step 4:

The Data will be collected on Pre Intervention i.e. Day 0, post intervention Day 12 & Day 21. Collected data will be analyzed for the study.

For the Experimental group (B)

Step 3:

In this group participants will be treated with Canal enlargement exercises, TENS, hot fomentation, static bicycling, balance training, class-IV LASER,.

Step 4:

The Data will be collected on pre intervention i.e. Day 0, post intervention Day 12 & Day 21. Collected data will be analysed for the study.

 

 
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