| CTRI Number |
CTRI/2024/04/066250 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of Stretching and MET in young adults with low back pain |
|
Scientific Title of Study
|
Effect of MET and Stretching on Lumbar Lordosis in Lower Cross Syndrome: RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preety |
| 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 |
9817877266 |
| Fax |
|
| Email |
preetysheoraan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonu Punia |
| 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 |
9466373990 |
| Fax |
|
| Email |
sonu.punianeuropt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonu Punia |
| 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 |
9466373990 |
| Fax |
|
| Email |
sonu.punianeuropt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Preety BPT Student Department of Physiotherapy Guru Jmabheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of
Science and Technology, Hisar Haryana 125001 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Nil |
| 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 |
| Preety |
Department of Physiotherapy Guru Jmabheshwar University of Science and Technology Hisar Haryana |
Guru Jmabheshwar University of Science and Technology HISAR Haryana Room no. 05 OPD Out Patient Department
Hisar
HARYANA |
9817877266
preetysheoraan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M404||Postural lordosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of muscles energy technique followed by Stretching exercise and Hot pack |
Patients in this group will perform stretching exercises with MET followed by Hot Pack for twenty minutes for three weeks |
| Comparator Agent |
Stretching exercises followed by Hot Pack |
Patients in this group will perform stretching exercises with hot pack for twenty minutes for three weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females willing to
participate in the study between age group
of 18 to 30 years and evaluation with
Thomas and Kendall test ( Ilio-psoas and
Rectus Femoris); Lordosis angle with Inclinometer application |
|
| ExclusionCriteria |
| Details |
History of spinal trauma, joint dysfunction
in past 3 months or congenital deformities
at hip or lumbar region, recent fracture to
hip and sacroiliac joint in past 6 months,
history of abdominal, hip or lumbar
surgeries in past 3 months and not willing
to participate in the study will be excluded
from the study |
|
|
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 |
Electromyography(EMG)
Numeric pain rating scale(NPRS)
Thomas Test
Kendal Test |
The outcome will be assessed for two times which is at baseline and after the three weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inclinometer to measure lordosis curve |
The outcome will be assessed for two times which is at baseline and after the three weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
05/05/2024 |
| 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 Yet Recruiting |
| 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 randomized controlled trial with a duration of three weeks and involving forty patients that will
be divided into two groups based on the random method. It’s intervention involves stretching exercises with MET followed by Hot pack in one group and Stretching exercises with hot pack in second group. The patient will be informed about the
study and written consent will be taken. Firstly each patients demographic information including age,
height and weight will be gathered as a baseline data. Pre intervention measurements of outcome
measures including Inclinometer, Thomas test, Kendall test, EMG, NPRS at lower back will be taken. Interventions will
be given for three weeks then post intervention data of all outcome measures will taken. |