| CTRI Number |
CTRI/2025/05/087842 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| 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
|
A study to assess the effect of hamstring stretching and core strengthening exercises on pain, balance, and disability in sedentary young adults with non-specific low back pain |
|
Scientific Title of Study
|
Effect of Hamstring stretching and core strengthening on Pain, Balance and Functional Disability among sedentary young adults with non - specific low back pain - A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jisa Rachel Sam |
| Designation |
Post Graduate Student |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
Taj Hill view Apartment
opposite: K.S.Hegde Medical College Hospital,
Derlakatte
Manglore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8075975496 |
| Fax |
|
| Email |
jisarachelsam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nityal Kumar |
| Designation |
Associate Professor |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
Medical Science complex , post Nithyanandha Nagar,Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nityal Kumar |
| Designation |
Associate Professor |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
Medical Science complex , post Nithyanandha Nagar,Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NITTE Deemed to be University |
| Address |
Nithyananda Nagar, Derlakette , Manglore, Karnataka Inida ,575018 |
| 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 |
| Jisa Rachel Sam |
NITTE Institute of Physiotherapy |
Nithyananda Nagar , Derlakette Manglore Karnataka
Dakshina Kannada
KARNATAKA |
08075975496
jisarachelsam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE OF NITTE INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non- Specific Low Back Pian |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercise Therapy |
Group B will receive only warm-up (walking, pelvic tilts), followed by standard care exercises (abdominal stretch, cat-camel, spinal extensions, superman, pelvic bridging), and the same cool-down routine. Sessions will also be 30 mins/day, 5 days/week for 8 weeks. Both groups will be assessed using VAS for pain, multidirectional reach test for postural stability, and ODI for functional disability |
| Intervention |
Hamstring Stretching and Core Strengthening |
They will be randomized using SNOSE into two groups (34 each). Group A will receive a structured exercise protocol including warm-up (walking, pelvic tilts), hamstring stretches (active with hip/knee control), core stability and strengthening exercises (double bridge, sit-ups, Russian swivel), followed by standard care (abdominal stretch, cat-camel, spine extension, superman, pelvic bridging), and ending with cool down (child’s pose, knee-to-chest stretch). Sessions will last 30 minutes/day, 5 days/week for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1) Low back pain of a nonspecific in nature
2) Young individuals suffering from at least a single episode of Low back pain in past 3 months or pain in past 6 weeks
3) With a VAS score of 4 and above
4) Engaged in less than 150 minutes of moderate intensity physical activity per week.
|
|
| ExclusionCriteria |
| Details |
1) Presence of neurological signs
2) No surgical history due to spinal problems
3) Having the specific disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity as measured by Visual Analogue Scale (VAS) |
Baseline and post-intervention (after 8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Balance – measured by Multi-Directional Reach Test (MDRT) |
Baseline (Week 0) and Post-intervention (End of Week 8)
|
Functional disability – measured by - Oswestry Disability Index (ODI)
|
Baseline and at the end of 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/06/2025 |
| Date of Study Completion (India) |
12/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This randomized controlled trial aims to assess the effect of hamstring stretching and core strengthening exercises on pain, balance, and functional disability in sedentary young adults with non-specific low back pain (NSLBP). A total of 68 participants aged 19–28 years who report at least one episode of low back pain in the past 6 weeks will be enrolled from Nitte Institute of Physiotherapy, Mangaluru. Participants will be randomly allocated into two groups: Group A (Experimental) will receive hamstring stretching and core strengthening exercises along with standard care, while Group B (Control) will receive standard care only. Each intervention will be performed for 30 minutes per day, 5 days a week for 8 weeks. Outcome measures including the Visual Analogue Scale (VAS) for pain, Oswestry Disability Index (ODI) for functional disability, and Multi-Directional Reach Test (MDRT) for balance will be recorded before and after the intervention. The results will help determine whether combined stretching and strengthening exercises are more effective than standard care in improving pain and function among sedentary young adults with NSLBP. |