| CTRI Number |
CTRI/2025/03/083215 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| 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
|
Effects of Exercises in Back pain |
|
Scientific Title of Study
|
Comparative Effect of Dynamic Neuromuscular Stabilization Exercises and
Core Strengthening Exercises in Young Adults with Chronic Low Back Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapil |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
7056308692 |
| Fax |
|
| Email |
kapildhall43993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujata Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9416918688 |
| Fax |
|
| Email |
sujatasharmaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujata Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9416918688 |
| Fax |
|
| Email |
sujatasharmaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kapil MPT Student Department of Physiotherapy Guru Jambheshwar
University of Science and Technology Hisar Haryana
125001
India |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Guru Jambheshwar University of
Science and Technology Hisar
Haryana 125001 India |
| 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 |
| Dr Sujata Sharma |
Guru Jambheshwar University of Science and Technology |
Room No 05
Department of
Physiotherapy
OPD GJUS&T
Hisar HARYANA
Hisar
HARYANA
Hisar
HARYANA |
9416918688
sujatasharmaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core Strengthening Exercises and hot Pack |
Patients in this group will perform of Core Strengthening Exercises and Hot Pack for 3 session per week for 6 weeks |
| Intervention |
Dynamic Neuromuscular Stabilization Exercises and Hot Pack |
Patients in this group will perform of Dynamic Neuromuscular Stabilization Exercises and Hot Pack for 3 session per week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age – 18 to 45 years
Gender- Both Males and Females
Non-specific low back pain for more than 3 months
|
|
| ExclusionCriteria |
| Details |
History of back pain due to any specific spinal pathological cause
Recent fractures of lower limb and spine
Any previous spinal and lower limb surgeries
Pregnant women
Presence of open wound on back
Patients with any neurological deficit
Uncooperative patient and patient not willing to participate in the study
Patients with unstable heart conditions
Any medical condition that restricts physical activity
Engaged in any other kind of exercise program |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Endurance - Sit-ups test
Oswestry Disability Index (ODI) |
The outcome will be assessed for two times which is at the baseline and after the 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Endurance - Sit-ups test |
The outcome will be assessed for two times which is at the baseline and after the 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2025 |
| 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="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a randomized controlled trial with a duration of 6 weeks and involving 50 patients that will be divided into two groups based on the lottery method. Its intervention involves dynamic neuromuscular stabilization exercise and hot pack in one group and core strengthening exercise and hot pack in second group. The patients will be informed about the study and written informed consent will be taken. First, each patient’s demographic information including age, height and weight will be gathered as a baseline data. Pre- Intervention measurements of outcome variables including VAS, SITS-UP, ODI will be taken. Intervention will be given for 6 weeks and then post-intervention data of all the outcome variables will be taken |