| CTRI Number |
CTRI/2025/07/091260 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Quick Relief from Shin Pain in the athlete with the help of Dry needle technique |
|
Scientific Title of Study
|
Short-term effect of dry needling with fascial winding technique on shin pain
in athletes having Medial Tibial Stress Syndrome – A Randomized control
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 |
Gaurav Bhatiwal |
| Designation |
|
| Affiliation |
|
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine,Guru nanak dev university, Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
7447380805 |
| Fax |
|
| Email |
gauravbhatiwal2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Bhatiwal |
| Designation |
MPT Sports Physiotherapy |
| Affiliation |
MYAS-GNDU Department of Sports Sciences and Medicine |
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine,Guru nanak dev university, Amritsar
MYAS-GNDU Department of Sports Sciences and Medicine,Guru nanak dev university, Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
7447380805 |
| Fax |
|
| Email |
gauravbhatiwal2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Bhatiwal |
| Designation |
MPT Sports Physiotherapy |
| Affiliation |
|
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine,Guru nanak dev university, Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
7447380805 |
| Fax |
|
| Email |
gauravbhatiwal2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gaurav Bhatiwal |
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine,Guru nanak dev university, Amritsar |
| 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 |
| Gaurav Bhatiwal |
MYAS- Guru Nanak Dev University |
Strength testing lab,MYAS-GNDU Department of Sports Sciences and Medicine,Guru nanak dev university, Amritsar
Amritsar
PUNJAB |
7447380805
gauravbhatiwal2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Guru Nanak Dev University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DRY NEEDLING WITH FASCIAL WINDING TECHNIQUE |
Dry needling (DN) involves penetration of a solid needle through the skin without the introduction of any drug to stimulate trigger points and connective tissue for the management of neuromusculoskeletal pain. Clinical studies have been shown that insertion of needle into the point of maximum pain results in pain relief and improved quality of life.Gascon-Garcia et al., has demonstrated that dry needling with the fascial winding technique can effectively apply traction to structures like the transverse carpal ligament, stretching and relaxing it. This technique can similarly be applied to the fascia along the medial tibial border to alleviate shin pain resulting from myofascial dysfunction. DN, particularly when combined with fascial manipulation, may provide therapeutic relief by addressing this fascial dysfunction.The total taken for the data collection will be around 45 minute. The 1 week of protocol will be there and The study will be done within 6 months.
|
| Comparator Agent |
SHAM DRY NEEDLING |
Sham DN (Placebo needle) consists of the use of blunted needle that does not penetrate the skin. And these sham needles can be used as valid control treatment when trying to establish the treatment effect of actual DN.The total taken for the data collection will be around 45 minute. The 1 week of protocol will be there and The study will be done within 6 months.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
SUBJECT SHOULD HAVE MECHANICAL SHIN PAIN |
|
| ExclusionCriteria |
| Details |
Participants having any diagnosed medical condition or nutritional disorder. Participants of having fear of needle should also be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCED SHIN PAIN CALCULATED USING SHIN PAIN SCORING SYSTEM (SPSS) AND NUMERICAL PAIN RATING SCALE |
REDUCED SHIN PAIN CALCULATED USING SHIN PAIN SCORING SYSTEM (SPSS) AND NUMERICAL PAIN RATING SCALE. The one week of protocol will be there with needling done on alternative days.The pre data and post needling data will be recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| Date of Study Completion (India) |
24/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
SUBJECTS HAVING SHIN PAIN WILL BE SELECTED USING INCLUSION AND EXCLUSION CRITERIA.THE SUBJECTS WILL BE RANDOMIZED INTO 2 GROUPS. SEVERITY OF SHIN PAIN WILL BE CALCULATED USING SHIN PAIN SCORING SYSTEM AND USING NUMERICAL PAIN RATING SCALE DURING REST, WALK AND RUN BEFORE NEEDLING AND AFTER NEEDLING. DATA WILL BE SUMMARIZED AFTER THE PROCEDURE. |