| CTRI Number |
CTRI/2025/08/092958 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing exercises that improve back stability with exercises that build back strength in young adults who have lower back pain |
|
Scientific Title of Study
|
Comparison of lumbar stabilization and lumbar strengthening protocol in nonspecific low back pain in sedentary young adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepesh pandit |
| Designation |
Post graduate student |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
MYAS GNDU, Department of Sports Sciences and Medicine, Guru Nanak Dev University
Amritsar
PUNJAB
143005
India |
| Phone |
08828443792 |
| Fax |
|
| Email |
pandit.deepesh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepesh pandit |
| Designation |
Post graduate student |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
MYAS GNDU, Department of Sports Sciences and Medicine, Guru Nanak Dev University
Amritsar
PUNJAB
143005
India |
| Phone |
08828443792 |
| Fax |
|
| Email |
pandit.deepesh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
MYAS GNDU, Department of Sports Sciences and Medicine, Guru Nanak Dev University
Amritsar
PUNJAB
143005
India |
| Phone |
9911690060 |
| Fax |
|
| Email |
namrata.sharma16nov@gmail.com |
|
|
Source of Monetary or Material Support
|
| MYAS GNDU, department of Sports Sciences and Medicine, Guru Nanak Dev University, Amritsar, Punjab, India, 143005 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
nil |
| Type of Sponsor |
Other [post graduate dissertation of a State University] |
|
|
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 |
| Dr Namrata Sharma |
Guru Nanak Dev University |
Rehabilitation center, MYAS GNDU, department of Sports Sciences and Medicine, Guru Nanak Dev University, Amritsar
Amritsar
PUNJAB |
9911690060
namrata.sharma16nov@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commitee of guru nanak dev university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Conventional exercises that they have been performing for Low back pain |
| Intervention |
Lumbar stabilization protocol |
1. Transverse abdominis activation
2.Dead bug
3.Side plank
4. Superman pose
5.Bird dog
6.Bridging
7.Plank
Each exercise to be performed
20 -30 sec hold, 3 repetition 3 times for 6 weeks |
| Intervention |
Lumbar Strengthening protocol |
1. Bridging
2. Curl ups with arm reaching forward
3. Curl ups with arm behind the head
4.Leg raises
5.Prone leg extension
6.Prone leg extension with legs slightly abducted
7.Prone back extension
With arm at the side
8.Quadruped kick backs
9.Russian twist
10.Supine Cycling
11.Alternate arm and leg extension in prone
12.Prone back extension
With arm behind the head
13.Bird dog
All exercises to be performed 10 repetition 3 times for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Young adults age 18-30 years.
2.Sedentary work according to IPAQ-SF (Less than 3 days of vigorous activity less than 20
minutes/day. Less than 5 days of moderate activity or walking less than 30 minutes/day). (Refer
Annexure IV for IPAQ-SF) .
3. Nonspecific low back pain which with sub-acute duration i.e pain less than 2 weeks duration.
4.Subject willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Individuals with recent fracture.
2. Some neurological illness (stroke, polyneuropathy).
3. Lack of understanding of the study (dementia, language Problems).
4. Infectious disease of spine.
5. Proven acute radiculopathy (ENMG) or severe pain below the knee (clinical
examination and interview). |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numerical Pain rating scale
2. Mc Gills torso muscular endurance test |
baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry disability Index score |
baseline and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/08/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is designed with the aim to compare lumbar stabilization and lumbar strengthening protocol in young adults with low back pain. Due to technological advancement most of the young adults lead a sedentary life which can be contributing to development of nonspecific LBP therefore we will include those adults leading a sedentary lifestyle according to International Physical Activity Questionnaire criteria and compare the effectiveness of 6 weeks lumbar stabilisation and lumbar strengthening intervention in comparison to controls on their low back pain symptoms and functional activity. OBJECTIVES 1.To assess the effect of 6 weeks lumbar stabilization protocol in comparison to control group on nonspecific LBP parameters namely Numerical pain rating scale (NPRS), Oswestry Disability Index (ODI) and Mc Gill’s torso muscular endurance test in sedentary young adults with nonspecific LBP. 2.To assess the effect of 6 weeks lumbar strengthening protocol in comparison to control group on nonspecific LBP parameters namely Numerical pain rating scale (NPRS), Oswestry Disability Index (ODI) and Mc Gill’s torso muscular endurance test in sedentary young adults with nonspecific LBP. 3.To compare the effectiveness between lumbar stabilization and lumbar strengthening protocols in improvement of nonspecific LBP in young adults.
Procedure- The patient will be selected based on inclusion criteria, will be assessed for Numerical pain rating scale (NPRS), Oswestry Disability Index (ODI) Questionnaire and Mc Gill’s torso endurance test at baseline. Then each patient will be randomly divided into three groups- Lumbar Strengthening , Lumbar Stabilization and Control group for exercise intervention. Then after six weeks of intervention, they will be reassessed for NPRS,ODI Questionnaire and Mc Gill’s torso endurance test. |