| CTRI Number |
CTRI/2025/03/081601 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| 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
|
Effect of Progressive Lumbar Stabilization Training on Autonomic Responses and Quality of Life in individual with Low Back Pain: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Progressive Lumbar Stabilization Training on Autonomic Responses and Quality of Life in individual with 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 |
Bhawna Yadav |
| Designation |
Student |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology |
| Address |
Departmet of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9518870745 |
| Fax |
|
| Email |
yadavbhawna610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonu Punia |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology |
| Address |
Departmet of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9466373990 |
| Fax |
|
| Email |
sonu.punianeuropt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonu Punia |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology |
| Address |
Departmet of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9466373990 |
| Fax |
|
| Email |
sonu.punianeuropt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhawna Yadav MPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar 125001 Haryana India |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology |
| Address |
Guru Jambheshwar University of Science and Technology Hisar 125001 Haryana 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 Sonu Punia |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology |
Room No. 4 Departmet of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar 125001 Haryana
Hisar
HARYANA |
9466373990
sonu.punianeuropt@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: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Patients in this group will receive conventional treatment of TENS of 100-150 Hz and ergonomic advices for 3 sessions for 4 weeks. |
| Intervention |
Lumbar Stabilization Training Group |
Patients in this group will receive lumbar stabilization training along with TENS of 100-150 Hz for 3 sessions per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. 19-45 years of age
2. Suffering from non specific low back pain from 8 weeks.
3. Not receiving any physiotherapy treatment
4. Reduced daily living activities
5. Pain score more than 3 |
|
| ExclusionCriteria |
| Details |
1. Already taking medications for LBP
2. History of spinal trauma, tumors, infections and surgery
3.Pain radiating to the lower limbs
4. Psychological disorders and uncooperative patients
5. Neuromuscular disorders
|
|
|
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 |
Heart Rate Variability
Quality of Life |
The outcomes will be assessed at the baseline and at the 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Blood Pressure |
The outcomes will be assessed at the baseline and at the 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
10/03/2025 |
| 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="0"
Days="28" |
|
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 4 weeks and include 32 participants that will be dividing into 2 groups- experimental group and control group by lottery method. Experimental group will receive progressive lumbar stabilization training along with High TENS and control group will receive High TENS. Informed consent will be obtained from the participants. Before the commencement of the study, demographic details including age, gender, height and weight will be obtained. The outcome measures Including heart rate variability, blood pressure, quality of life and pain will be assessed at the baseline and at the end of the study which is after 4 weeks. |