| CTRI Number |
CTRI/2023/10/058837 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| 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
|
Dry needling for Shin pain |
|
Scientific Title of Study
|
Effectiveness of Dry needling on pain and ROM in athletes with Medial Tibialis Stress Syndrome- A clinical trial |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrinder singh |
| Designation |
Associate professor |
| Affiliation |
MYAS-GNDU Department of sports science and Medicine Guru Nanak Dev University Amritsar, Punjab |
| Address |
MYAS-GNDU Department of sports science and Medicine Guru Nanak Dev University Amritsar,
Punjab
Amritsar
PUNJAB
143005
India |
| Phone |
9501114474 |
| Fax |
1832258820 |
| Email |
amrindersportsmed@gndu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrinder singh |
| Designation |
Associate professor |
| Affiliation |
MYAS-GNDU Department of sports science and Medicine Guru Nanak Dev University Amritsar, Punjab |
| Address |
MYAS-GNDU Department of sports science and Medicine Guru Nanak Dev University Amritsar,
Punjab
Amritsar
PUNJAB
143005
India |
| Phone |
9501114474 |
| Fax |
1832258820 |
| Email |
amrindersportsmed@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Wadhwani |
| Designation |
MPT Sports physiotherapy student |
| Affiliation |
MYAS-GNDU Department of sports science and Medicine Guru Nanak Dev University Amritsar, Punjab |
| Address |
Room no. 1310, Block 1, GH4,Guru Nanak Dev University, Amritsar, Punjab
Amritsar
PUNJAB
143005
India |
| Phone |
8208898990 |
| Fax |
1832258820 |
| Email |
nikiwadhwani24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of sports science and Medicine Guru Nanak Dev University Amritsar,
Punjab-143005 |
|
|
Primary Sponsor
|
| Name |
Nikita Wadhwani |
| Address |
Room no. 1310, Block 1, GH4,Guru Nanak Dev University, Amritsar, Punjab |
| 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 Amrinder Singh |
MYAS-GNDU Department of sports science and Medicine Guru Nanak Dev University Amritsar, Punjab |
Guru Nanak Dev University Amritsar,
Punjab
143005
Amritsar
PUNJAB |
09501114474
amrindersportsmed@gndu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Guru Nanak Dev University, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
medial tibial stress syndrome |
| Patients |
(1) ICD-10 Condition: S861||Injury of other muscle(s) and tendon(s) of posterior muscle group at lower leg level, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dry needling |
3 sessions, alternate days for 1 week |
| Comparator Agent |
rest |
Pain and range of motion would be checked after 1 week of rest |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Medial tibial stress syndrome diagnosis with physical examination & history is positive |
|
| ExclusionCriteria |
| Details |
Non-athletes.
In athletes with any history of stress fracture of tibia & posterior compartment syndrome,
one year prior injury.
In athletes with any history of Meniscal tears, ligamentous sprains, osteoarthritis &
muscular strains one year prior injuries.
Fear of needle. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain decrease & range of motion increase |
1 week of trail |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no effect of dry needling in pain & range of motion |
6 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
29/10/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 study mainly focuses on soleus muscle taught band which causes pain on posteromedial tibial border over a length of ≥5 consecutive centimeters. Exercises to stretch the soleus in MTSS are no longer considered as a strongly evidence-based treatment approach. The purpose of this clinical trial is to determine the effectiveness of Dry Needling as a primary treatment in subjects with Medial tibial stress syndrome Athletes will be diagnosed on the basis of history and physical examination proposed by M Winter Athletes will be selected from university for the study based on inclusion and exclusion criteria Dry needling will be done in prone lying position. soleus will be exposed and cleaned with 70% isopropyl alcohol swabs for skin preparation and then 40 mm dry needle will be inserted into the tender nodules of muscle by holding muscle in pincer grip and pulling it away from midline to avoid neurovascular bundle. Needle will be inserted in anteromedial direction in the muscle. The needles will then left in-situ for 15 minutes Pain will be measured by VAS scale and ROM will be measured by universal goniometer; prior to and after applying the intervention |