| CTRI Number |
CTRI/2025/08/092933 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of the effect of TENS and cryotherapy in postoperative rehabilitation in patients undergoing ACL reconstruction. |
|
Scientific Title of Study
|
Comparing TENS and crotherapy for improving muscle strength and return to sports scores in patients with ACL reconstruction: 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 |
Dr Sumit Banerjee |
| Designation |
Professor Orthopaedics |
| Affiliation |
All India Institute of medical sciences Jodhpur |
| Address |
Dept of Orthopaedics
ground floor C block Room 50
AIIMS Hospital Basni MIA 2nd phase
Jodhpur Rajsthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9910895314 |
| Fax |
|
| Email |
drsumitbanerjee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Banerjee |
| Designation |
Professor Orthopaedics |
| Affiliation |
All India Institute of medical sciences Jodhpur |
| Address |
Dept of Orthopaedics
Ground floor c block Room 50
AIIMS Hospital Basni MIA 2nd phase
Jodhpur Rajsthan 342005
RAJASTHAN
342005
India |
| Phone |
9910895314 |
| Fax |
|
| Email |
drsumitbanerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhil Mathew Jacob |
| Designation |
Post Doctoral Fellow |
| Affiliation |
All India Institute of medical sciences Jodhpur |
| Address |
Dept of Orthopaedics
Ground floor c block room 50
AIIMS Hospital Basni MIA 2nd phase
Jodhpur Rajsthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8848661303 |
| Fax |
|
| Email |
akhilmj17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
All India Institute of medical sciences Jodhpur
BASNI MIA 2ND PHASE
JODHPUR RAJSTHAN 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SUMIT BANERJEE |
All India Institute of medical sciences (AIIMS) Jodhpur |
BASNI MIA 2ND PHASE JODHPUR
RAJSTHAN 342005
Jodhpur
RAJASTHAN |
9910895314
drsumitbanerjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TENS |
Providing TENS to the patients operated for ACL reconstruction |
| Comparator Agent |
Cryotherapy |
cryotherapy will be provided for patient operated with ACL reconstruction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
operated cases of acl reconstrucion |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in muscle strength in the 2 groups |
4, 6 , 9 months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in return to sports scores in the 2 randomised groups |
at 9 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="1"
Days="1" |
|
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
|
The study will be a randomised controlled trial conducted in the department of Orthopaedics along with the dept. of physical medicine and rehabilitation. 60 patients will be recruited who have undergone ACL reconstruction. they will be divided in to 2 groups of 30 each . each group will be givne TESn or cryotherapy for rehabilitation.these session will be conducted in 1,2, 4, 6 weeks postoperatively. The muscle strength willbe assessed at 4, 6, 9 months and the return to sports will be assessed at 9 months. |