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CTRI Number  CTRI/2021/04/033178 [Registered on: 28/04/2021] Trial Registered Prospectively
Last Modified On: 03/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical and imaging trial to study which one is more effective in between platelet rich plasma injection in comparison to Extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis. 
Scientific Title of Study   A randomized control trial of clinical and imaging effect of platelet rich plasma injection in comparison to Extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niraj kumar 
Designation  Junior resident 
Affiliation  Department of PMR AIIMS Patna 
Address  Department o PMR AIIMS PATNA

Patna
BIHAR
801507
India 
Phone  7903464407  
Fax    
Email  nirajkumar@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Kumar Pandey 
Designation  Additional professor and Head 
Affiliation  Department of PMR AIIMS Patna 
Address  Department of PMR,PMR Building Phulwari AIIMS PATNA
Department PATNA of PMR,PMR Building Phulwari AIIMS
Patna
BIHAR
801505
India 
Phone  918102922824  
Fax    
Email  Sashisanjaysashi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Niraj kumar 
Designation  Junior resident 
Affiliation  Department of PMR AIIMS Patna 
Address  Department o PMR AIIMS PATNA

Patna
BIHAR
801507
India 
Phone  7903464407  
Fax    
Email  nirajkumar@aiimspatna.org  
 
Source of Monetary or Material Support  
Not applicable  
 
Primary Sponsor  
Name  AIIMS PATNA 
Address  Department of PMR AIIMS Patna  
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 Niraj kumar  AIIMS Patna   Department of PMR AIIMS Patna phulwari
Patna
BIHAR 		 7903464407

nirajkumar@aiimspatna.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee AIIMS Patna   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Extracorporeal shock wave therapy(ESWT) in plantar fascitiis  ESWT is a sound wave generated by ESWT machine and will be applied locally with probe only once with 2000 shock wave pulses with repetition frequency 2 pulses per second at deseased plantar fasciia 
Intervention  Platelet rich plasma in plantar fascitiis  Platelet rich plasma will be made by centrifugation of patient 15 ml whole blood and will be given locally at diseased plantar fascia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with unilateral chronic plantar fasciitis
Patients with pain intensity more than 5 on Visual Analog Scale
Consenting patients 
 
ExclusionCriteria 
Details  Patients with history of cardiac pacemaker calcaneal fracture previous surgery involving foot autoimmune disorders systemic inflammatory disorder neurological disorder any psychological disorder or any uncontrolled systemic disease
Known case of bleeding disorder
Presence of skin infection at the site of injection
Patients having bilateral plantar fasciitis
Patients having severe anemia Hb less than 6.5 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale for pain
AOFAS Score for function 		 0day,15 day ,1month,and at 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Plantar fasciia thikness  0 day,15 days,1month,and at 3 month 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2021 
Date of Study Completion (India) 28/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not yet published. 
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 (Others) -  data will be shared after de-identification

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response (Others) -  study protocol will be shared.
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.

  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 (Others) -  nil

  6. For how long will this data be available start date provided 17-04-2021 and end date provided 16-04-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  
Plantar fasciitis is painful and disabling condition of foot.pathology behind plantar fasciitis is primarily degenerative instead of inflammatory.in this study we want to compare efficacy of platelet rich plasma in terms of pain relief and functional improvement with Extracorporeal shock wave therapy in chronic plantar fasciitis.

 
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