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CTRI Number  CTRI/2025/10/096643 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of conventional and PRP injection in ATFL sprain patients 
Scientific Title of Study   COMPARISON OF CLINICO-RADIOLOGICAL AND FUNCTIONAL OUTCOMES BETWEEN LOCAL PLATELET RICH PLASMA(PRP) INJECTION VERSUS CONVENTIONAL TREATMENT MODALITY FOR LATERAL ANKLE SPRAIN INJURIES: RANDOMIZED CONTROL STUDY  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAJESH KUMAR RAJNISH 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS JODHPUR 
Address  DEPARTMENT OF ORTHOPAEDICS AIIMS JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342005
India 
Phone  08955444773  
Fax    
Email  duktiraj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  RAJESH KUMAR RAJNISH 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS JODHPUR 
Address  DEPARTMENT OF ORTHOPAEDICS AIIMS JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342005
India 
Phone  08955444773  
Fax    
Email  duktiraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  RAJESH KUMAR RAJNISH 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS JODHPUR 
Address  DEPARTMENT OF ORTHOPAEDICS AIIMS JODHPUR RAJASTHAN

Jodhpur
RAJASTHAN
342005
India 
Phone  08955444773  
Fax    
Email  duktiraj@gmail.com  
 
Source of Monetary or Material Support  
AIIMS JODHPUR 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  AIIMS JODHPUR 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR NIKHIL VL  All India Institue of Medical sciences , Jodhpur  ROOM NO 54,GROUND FLOOR, DEPARTMENT OF ORTHOPAEDICS AIIMS JODHPUR
Jodhpur
RAJASTHAN 		 7975414440

nikhillakshman3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Clinical Trial)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S934||Sprain of ankle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL CONSERVATIVELY MANAGED PATIENTS  All the patients included shall be divided into two groups A and B (16 patients in each group). In group A (control), no injection shall be given at injury site; in group B (Intervention), ONE PRP injection shall be given within 48 hours of the sprain. Autologous PRP injection shall be given under ultrasound guidance to the injured ATFL. It will be followed by a below knee Plaster of Paris slab ankle in a neutral position, and shall be advised to bear weight as soon as the pain permits. In the control group, the ankle shall be put in a below-knee Plaster of Paris slab in a neutral position and shall be advised to bear weight as soon as the pain permits. The below knee slab shall be removed in all groups of patients after one week, and an ankle sprain brace shall be given to all patients.  
Intervention  PRP INJECTION PATIENTS  All the patients included shall be divided into two groups A and B (17 patients in each group). In group A (control), no injection shall be given at injury site; in group B (Intervention), ONE PRP injection shall be given within 48 hours of the sprain. Autologous PRP injection shall be given under ultrasound guidance to the injured ATFL. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  PATIENT AGED 18-60 YEARS
FIRST TIME LATERAL ANKLE SPRAIN
DURATION OF INJURY LESS THAN 48 HOURS OF INJURY
GRADE 2
MILD TO MODERATE INSTABILITY  
 
ExclusionCriteria 
Details   
 
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 
1. To compare the pain on VAS (Visual Analog Scale) score at 0, 6, and 24 weeks of PRP injection
2. To compare the ankle functional outcomes based on AOFAS score at 0,6, and 24 weeks of PRP injection
 		 0,6,24 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Foot & ankle disability index (FADI) at 0, , 6, & 24 weeks of PRP injection
 		 0,6,24 WEEKS 
To compare the ankle functional outcomes based on ankle ultrasound scan evaluation at 0,6 and 24 weeks
2.To compare the foot and ankle disability index at 0,2,6,12 and 24 weeks  		  
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/11/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (nikhillakshman3@gmail.com).

  6. For how long will this data be available start date provided 30-10-2024 and end date provided 30-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Brief Summary:
Lateral ankle sprain is a common injury, especially in young active individuals, most often involving the anterior talofibular ligament. Although conservative management provides good recovery in most cases, many patients develop chronic ankle instability. Platelet rich plasma (PRP) therapy has shown potential in enhancing soft tissue healing due to its high concentration of growth factors. This study aims to evaluate the clinical effectiveness of autologous PRP in acute lateral ankle sprain using pain and function scores, and to assess its effect on ligament quality by analyzing the signal to noise ratio of the anterior talofibular ligament on ultrasound imaging.

 
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