| CTRI Number |
CTRI/2024/11/076438 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to find association between Hamstring tightness and Low Back Pain in Young adults |
|
Scientific Title of Study
|
Relationship in Between Hamstring tightness and Low Back Pain in Young adults: A Correlational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Sharma |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
PLOT NO-2, SECTOR-17, YAMUNA EXPRESSWAY
GREATER NOIDA, GAUTAM BUDH NAGAR
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9315512650 |
| Fax |
|
| Email |
mohitsharma6267@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akriti Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
PLOT NO-2, SECTOR-17, YAMUNA EXPRESSWAY
GREATER NOIDA, GAUTAM BUDH NAGAR
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711793086 |
| Fax |
|
| Email |
akriti.pandey@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Sharma |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
PLOT NO-2, SECTOR-17, YAMUNA EXPRESSWAY
GREATER NOIDA, GAUTAM BUDH NAGAR
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9315512650 |
| Fax |
|
| Email |
mohitsharma6267@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University, PLOT NO-2, SECTOR-17, YAMUNA EXPRESSWAY, GREATER NOIDA, GAUTAM BUDH NAGAR, UTTAR PRADESH, 203201 |
|
|
Primary Sponsor
|
| Name |
Akriti Pandey |
| Address |
Plot no 2 sector 17 A Yamuna Expressway, Greater Noida, Gautam Buddh Nagar 203201 |
| Type of Sponsor |
Other [Guide] |
|
|
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 |
| Mohit Sharma |
Physiotherapy OPD, Galgotias University |
Plot no 2 , Sector 17 A ,Yamuna expressway , Gautam Buddh Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9315512650
mohitsharma6267@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young College Students |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.College going students.
2.Age should be in between 18-25.
3.Having LBP for more than 3 months. |
|
| ExclusionCriteria |
| Details |
1.History of any injury in spine.
2.Have LBP due to dic herniation.
3.BMI greater than 30. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sit and Reach Test |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
11/11/2024 |
| 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="3"
Days="0" |
|
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
|
Hamstring is the major muscle help in knee flexion and hip extension. It also plays an important role in stabilizing the posture and gait. Nowadays the prevalence of Hamstring tightness is more in young adults due to a sedentary lifestyle and physical inactivity. Young adults aged from 18-25 are more prone to develop hamstring tightness due to sitting for long hours in the classroom. The present study will examine the correlation between the hamstring tightness and LBP in young adults aged 18-25 years. This study involves both males and females (n=250). The study does not involve the participants who have any injury in the spine and have any other pathology. The flexibility of the hamstring will be evaluated through the sit and reach test. The LBP will be quantified using Numeric Pain Rating Scale (NPRS). Sit and reach test and NPRS will be evaluated at the baseline. All statistical analysis will be carried out by using Software IBM SPSS 21 for Windows Version. |