| 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 |
deeksha 0075sharma@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 |
deeksha 0075sharma@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
|
|
|
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
deeksha 0075sharma@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
|
|
|
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
|
|
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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. |