FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073961 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Cluster Randomized Trial 
Public Title of Study   Protocol for front knee pain for the population of hilly terrain with conservative management without medication 
Scientific Title of Study   Prevalence of Patellofemoral Pain in Hilly Terrain and its Conservative management on Distal Factor  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jay Prashant Darjee 
Designation  Physiotherapist 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences(NEIGRIHMS),Shillong 
Address  Dept.of Orthopaedics North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences(NEIGRIHMS) Shillong

East Khasi Hills
MEGHALAYA
793018
India 
Phone  793018  
Fax    
Email  jppt@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jay Prashant Darjee 
Designation  Physiotherapist 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences(NEIGRIHMS),Shillong 
Address  Dept of Orthopaedics North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences(NEIGRIHMS) Shillong

East Khasi Hills
MEGHALAYA
793018
India 
Phone  793018  
Fax    
Email  jppt@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Jay Prashant Darjee 
Designation  Physiotherapist 
Affiliation  ,North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences(NEIGRIHMS)Shillong 
Address  dept.of orthopaedics North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences(NEIGRIHMS) Shillong

East Khasi Hills
MEGHALAYA
793018
India 
Phone  793018  
Fax    
Email  jppt@rediffmail.com  
 
Source of Monetary or Material Support  
North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences(NEIGRIHMS),Shillong 
 
Primary Sponsor  
Name  North Eastern Indira Gandhi Regional Institute of Health Medical SciencesNEIGRIHMS 
Address  Shillong,Meghalay pin-793018 
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 Bhaskar Borgohain  North Eastern Indira Gandhi Regional Institute of Health And Medical Sciences  Department of Orthopedics,NEIGRIHMS,Shillong
East Khasi Hills
MEGHALAYA 		 9436563378

icmrborgbhaskar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics committe,North Eastern Indira Gandhi Regional Institute of Health & medical Sciencs(NEIGRIHMS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise Protocol,Orthotics  EMG of specific muscles will be taken for participants. Home-based exercise protocol will be demonstrated. 3D printed customised Orthotic device will be developed. Frequency: Once for each subjects .Duration:at least one reading for each subject. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects with anterior knee pain
Population: Residents of hilly terrain
 
 
ExclusionCriteria 
Details  Foot and ankle pathology or symptoms of pain
Systemic or inflammatory ailment
Knee pathology (e.g. instability, trauma, dislocations, tendinopathy)
Concomitant pain from other structures hip or lumbar spine
Recent treatment for Patellofemoral pain

Knee or hip arthroplasty or osteotomy
Planned lower limb surgery in the following months
Patellar alta and baja
Congenital deformity of knee, foot and ankle
Limb length discrepancy
Allergy to silver and with pacemaker implant
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain relief   3 moths,06 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
effect of Pain Relief & orthotic on functional status  by 12 months 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   01/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  not applicable

  6. For how long will this data be available start date provided 01-03-2025 and end date provided 31-12-2025?
    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  

Abstract 

Introduction:

It is not clear from the earlier studies that conservative management confined only to the distal factors of the intrinsic aetiology of PFP(not the local and proximal factors) will take care of the extrinsic factors of the aetiology of PFP. This study aims to see the effectiveness of tailored exercise protocol and Orthotic devices using additive manufacturing in PFP in hilly terrain.

Methods:

Diagnosed cases of PFP in the age group of 15-50 will be included, excluding the systemic, congenital deformity and traumatic conditions. Pre-intervention pain will be recorded using the PFP checklist and anterior knee pain scale. Bio-mechanical study for knee kinematics will be done using foot posture index, arch index, and navicular drop test. A kinetic study will be done using a force platform and EMG.3D printed customised orthosis will be designed, and gold standard Physiotherapeutic exercise protocol will be administered based on findings. 

Contribution of paper:

·      The research will be a novelty in the file of rehabilitation of patella-femoral pain especially residents of hilly terrain.

·      This research will develop a tailored Physiotherapy exercise protocol for Patellofemoral pain.

·      The tailored 3D printing orthotic developed from this study will be a milestone in correction foot biomechanics which will take care of extrinsic factors by working on the intrinsic factors.

 
Close