| CTRI Number |
CTRI/2025/11/097076 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| 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
|
Compare the effects of Dry Needling and vibrating Foam Rolling for Hamstring Tightness in University Students |
|
Scientific Title of Study
|
Immediate Effects of Myofascial Stretch Dry Needling and Vibrating Fitness Roller on Hamstring Muscle Tightness in University Students: A Randomized Clinical 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 |
Dr Varun Kalia |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professonal University Jalandhar |
| Address |
Block 3 Room No- 105 OPD, Department of Physiotherapy School of Allied Medical Sciences Lovely Professional University Jalandhar Delhi.G.T.Road,Chaheru,Phagwara,Punjab(INDIA)144411
Kapurthala
PUNJAB
144411
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26570@lpu.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Kalia |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professonal University Jalandhar |
| Address |
Block 3 Room No- 105 OPD, Department of Physiotherapy School of Allied Medical Sciences Lovely Professional University Jalandhar Delhi.G.T.Road,Chaheru,Phagwara,Punjab(INDIA)144411
Kapurthala
PUNJAB
144411
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26570@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Kalia |
| Designation |
Associate Professor |
| Affiliation |
Lovely Professonal University Jalandhar |
| Address |
Block 3 Room No- 105 OPD, Department of Physiotherapy School of Allied Medical Sciences Lovely Professional University Jalandhar Delhi.G.T.Road,Chaheru,Phagwara,Punjab(INDIA)144411
Kapurthala
PUNJAB
144411
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26570@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University |
|
|
Primary Sponsor
|
| Name |
Dr. Varun Kalia |
| Address |
Lovely Professional University (LPU) is Jalandhar-Delhi G.T. Road, Chaheru, Phagwara, Punjab (INDIA) -144411 |
| Type of Sponsor |
Other [Self] |
|
|
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 Suresh Mani |
Lovely Professional University |
Room No 105 Block 03 Department Of Physiotherapy, Lovely School Of Allied Medical sciences.
Kapurthala
PUNJAB |
9878331006
suresh.22315@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University (IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Myofacial Trigger Points in Hamstrings Muscles |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
A total 75 participants will be included in the study based on inclusion and exclusion criteria and then participants will be randomly allocated into groups (n-25).Before participation, each individual will be informed about the purpose and procedure of the study, and written informed consent will be obtained.Then he or she will be asked to wear comfortable clothing to allow free movement of the lower limbs. Participants will be allocated to Group 3 using the lottery method, where each participant will randomly select a lot from a set of concealed lots representing the intervention groups, ensuring unbiased group assignment. Initially, the Sit and Reach Test will be performed to assess hamstring tightness and establish a baseline measure of flexibility. A hot pack will then be applied to the posterior thigh region for 15 minutes to increase local blood flow, enhance tissue extensibility, and prepare the muscles for intervention. Immediately afterward, static hamstring stretching will be performed, with each stretch held for 30 seconds and repeated three times, with a 10-second rest between repetitions, to improve muscle length and flexibility. The Sit and Reach Test will then be repeated to assess immediate changes in hamstring flexibility. Finally, the participant will be advised to apply icing at home to the treated area for 10 minutes to reduce post-intervention soreness and prevent inflammation. |
| Intervention |
Dry Needling group |
A total 75 participants will be included in the study based on inclusion and exclusion criteria and then participants will be randomly allocated into groups (n-25). Before participation, each individual will be informed about the purpose and procedure of the study, and written informed consent will be obtained.Then he or she will be asked to wear comfortable clothing to allow free movement of the lower limbs. Participants will be allocated to Group 1 using the lottery method, where each participant will randomly select a lot from a set of concealed lots representing the intervention groups, ensuring unbiased group assignment. Initially, the Sit and Reach Test will be performed to assess hamstring tightness and establish a baseline measure of flexibility. Following this, a hot pack will be applied to the posterior thigh region for 15 minutes to increase local blood flow, enhance tissue extensibility, and prepare the muscles for subsequent interventions. After the application of heat, dry needling will be performed at the hamstring myofascial trigger points using a sterile, fine needle of 0.30 × 40 mm. Each myofacial trigger point will be needled for about 30–60 seconds, eliciting a local twitch response to reduce muscle tension and facilitate relaxation of the tight hamstring fibers. Immediately following dry needling, static hamstring stretching will be performed, with each stretch held for 30 seconds and repeated three times, with a 10-second rest between repetitions, to further improve muscle length and flexibility. After completing the stretching, the Sit and Reach Test will be repeated to assess the immediate effects of the intervention and confirm improvements in hamstring flexibility. Finally, the participant will be advised to apply icing at home to the treated area for 10 minutes to reduce post-intervention soreness and prevent potential inflammation. |
| Intervention |
Vibrating Foam Roller group |
A total 75 participants will be included in the study based on inclusion and exclusion criteria and then participants will be randomly allocated into groups (n-25).Before participation, each individual will be informed about the purpose and procedure of the study, and written informed consent will be obtained.Then he or she will be asked to wear comfortable clothing to allow free movement of the lower limbs. Participant will be allocated to Group 2 using the lottery method, where each participant will randomly select a lot from a set of concealed lots representing the intervention groups, ensuring unbiased group assignment. Initially, the Sit and Reach Test will be performed to assess hamstring tightness and establish a baseline measure of flexibility. A hot pack will then be applied to the posterior thigh region for 15 minutes to increase local blood flow, enhance tissue extensibility, and prepare the muscles for intervention. Following the heat application, participants will utilize a vibrating foam roller on the hamstring region for 10 minutes to reduce muscle stiffness, increase blood flow, and improve tissue mobility. Immediately afterward, static hamstring stretching will be performed, with each stretch held for 30 seconds and repeated three times, with a 10-second rest between repetitions, to further improve muscle length and flexibility. The Sit and Reach Test will then be repeated to assess immediate changes in hamstring flexibility. Finally, the participant will be advised to apply icing at home to the treated area for 10 minutes to reduce post-intervention soreness and prevent inflammation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
University students between the ages of 18 and 25 years, exhibiting hamstring tightness as indicated by a Sit and Reach Test score falling below the normative range or an Active Knee
Extension Test showing greater than 20° from full extension, including both male and female participants, who provided voluntary written informed consent. |
|
| ExclusionCriteria |
| Details |
History of neurological conditions, sciatica, or radiculopathy, recent injuries to the musculoskeletal system or surgeries involving the lower limbs; the use of pain relievers, muscle
relaxants, or any ongoing therapeutic interventions ,bleeding disorders, skin infections, or a fear of needles (specifically for the dry needling group). |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) Pressure Pain Threshold (PPT). |
1 day- Pre test reading before treatment.
1 day- Post test reading after the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sit & Reach Test. |
1 day- Pre test reading before treatment.
1 day- Post test reading after the treatment. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
03/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
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
|
This randomized clinical trial aims to compare the immediate effects of Myofascial Stretch Dry Needling (MSDN) and Vibrating Fitness Roller (VFR) on hamstring muscle tightness among university students aged 18–25 years. A total of 75 participants with clinically confirmed hamstring tightness will be randomly divided into three groups: Group 1 received MSDN with conventional physiotherapy, Group 2 received VFR with conventional physiotherapy, and Group 3 received only conventional physiotherapy. Each intervention lasted 10–15 minutes, and outcomes were assessed before and after treatment using the Visual Analogue Scale (VAS), Pressure Pain Threshold (PPT), and Sit and Reach Test to evaluate pain and flexibility. The study seeks to determine which intervention provides greater immediate improvement in hamstring flexibility and pain reduction. |