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CTRI Number  CTRI/2024/08/072523 [Registered on: 14/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessing the Impact of Neuropathic Pain on Physical Function, Quality of Life, and Disease Severity in Knee Osteoarthritis Patients 
Scientific Title of Study   Correlation of Physical Function, Quality of Life and Disease Severity with Neuropathic Pain in Patients with Primary Knee Osteoarthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AIIMSG/IEC/M5/P24/2024 dated may 31 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rinsha Febin M  
Designation  Junior Resident - Academic  
Affiliation  All india institute of medical sciences Guwahati  
Address  Room no.104 PG hostel Department of Physical Medicine and Rehabilitation All india institute of medical sciences Guwahati Silbharal Changsari, Guwahati, Assam 781101

Kamrup
ASSAM
781101
India 
Phone  9061636588  
Fax    
Email  rinshafebinrasheedm1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satyaranjan Sethi  
Designation  Associate professor  
Affiliation  All india institute of medical sciences Guwahati  
Address  Room no. 1075 Department of Physical Medicine and Rehabilitation All india institute of medical sciences Guwahati Silbharal Changsari, Guwahati, Assam 781101

Kamrup
ASSAM
781101
India 
Phone    
Fax    
Email  drsatya.1979@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rinsha Febin M  
Designation  Junior Resident - Acade 
Affiliation  All india institute of medical sciences Guwahati  
Address  Room no.104 PG hostel Department of Physical Medicine and Rehabilitation All india institute of medical sciences Guwahati Silbharal Changsari, Guwahati, Assam 781101

Kamrup
ASSAM
781101
India 
Phone  9061636588  
Fax    
Email  rinshafebinrasheedm1997@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Guwahati Silbharal Changsari, Guwahati, Assam 781101 India  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [Nil] 
 
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 Rinsha Febin M   All India Institute of Medical Sciences Guwahati   Room no. 1075 Department of Physical Medicine and Rehabilitation All india institute of medical sciences Guwahati Silbharal Changsari, Guwahati, Assam 781101
Kamrup
ASSAM 		 9061636588

rinshafebinrasheedm1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Guwahati   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with primary knee osteoarthritis fulfilling ACR criteria (1986).
Written informed consent.
Patients with knee OA symptoms more than 3 months duration 
 
ExclusionCriteria 
Details  Patients with secondary knee osteoarthritis.
Severe cognitive impairment affecting participation.
Other severe neurological or musculoskeletal disorders of lower limb affecting quality of life or physical function. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Provide insights into the neuropathic pain in patients with primary knee osteoarthritis, its correlation with physical function, quality of life and disease severity.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Contributing to our understanding of the disease. Furthermore, it may influence future treatment approaches.
 		 3-5 years 
 
Target Sample Size   Total Sample Size="143"
Sample Size from India="143" 
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)   03/03/2025 
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="2"
Months="0"
Days="0" 
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   There is paucity of study on neuropathic pain in primary knee osteoarthritis despite the high prevalence of osteoarthritis of knee joint in Indian population. The lone study on neuropathic pain in primary OA knee was conducted in southern part of India. Hence this component of knee OA is yet to be explored in north east India.
Neuropathic component of pain has a significant impact on physical function, quality of life, and disease severity.
Understanding the correlation between neuropathic pain and physical function, quality of life, and disease severity can lead to improved management strategies and better outcomes for patients.

     Additionally, it can contribute to the development of targeted treatment strategies and interventions tailored to address neuropathic pain specifically in Indian population. Therefore, this study attempts to investigate these aspects of the disease which may improve the current treatment strategies.
 
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