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CTRI Number  CTRI/2023/06/054401 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [INTERVENTIONAL PAIN MANAGEMENT- GENICULAR NERVE BLOCK]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Targetting nerves supplying the knee joint for the treatment of Osteoarthritis of Knee 
Scientific Title of Study   Comparing the effectiveness of Ultrasound guided Genicular Nerve block using 3 point approach versus 5 point approach for pain and quality of life in patients of chronic osteoarthritis of knee 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAVI GAUR 
Designation  ADDITIONAL PROFESSOR 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR 
Address  DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, ROOM 15, AIIMS, MARUDHAR INDUSTRIAL AREA, 2ND PHASE, M.I.A, 1ST PHASE, BASNI, JODHPUR, RAJASTHAN
DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, ROOM 15, AIIMS, MARUDHAR INDUSTRIAL AREA, 2ND PHASE, M.I.A, 1ST PHASE, BASNI, JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342001
India 
Phone  8299711753  
Fax    
Email  ravisms80@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MEGHA BHARGAVA 
Designation  JUNIOR RESIDENT [ACADEMIC] 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR 
Address  DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, AIIMS, MARUDHAR INDUSTRIAL AREA, 2ND PHASE, M.I.A, 1ST PHASE, BASNI, JODHPUR, RAJASTHAN

Jodhpur
RAJASTHAN
342005
India 
Phone  9811921802  
Fax    
Email  meghabhargava@outlook.in  
 
Details of Contact Person
Public Query
 
Name  MEGHA BHARGAVA 
Designation  JUNIOR RESIDENT [ACADEMIC] 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR 
Address  DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, AIIMS, MARUDHAR INDUSTRIAL AREA, 2ND PHASE, M.I.A, 1ST PHASE, BASNI, JODHPUR, RAJASTHAN


RAJASTHAN
342005
India 
Phone  9811921802  
Fax    
Email  meghabhargava@outlook.in  
 
Source of Monetary or Material Support  
AIIMS, MARUDHAR INDUSTRIAL AREA, 2ND PHASE, M.I.A, 1ST PHASE, BASNI, JODHPUR, RAJASTHAN 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR 
Address  AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 
Type of Sponsor  Research institution and hospital 
 
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 
MEGHA BHARGAVA  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR  AIIMS, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 
9811921802

meghabhargava@outlook.in 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GENICULAR NERVE BLOCK- 3 POINT APPROACH  THE 3 POINT APPRAOCH WILL TARGET SUPEROMEDIAL, SUPEROLATERAL AND INFEROMEDIAL BRANCHES OF GENICULAR NERVES UNDER ULTRASOUND GUIDANCE USING PREDETERMINED ANATOMICAL LADMARKS. 
Intervention  GENICULAR NERVE BLOCK- 5 POINT APPROACH  THE 5 POINT APPRAOCH WILL TARGET SUPEROMEDIAL, SUPEROLATERAL AND INFEROMEDIAL BRANCHES OF GENICULAR NERVES. RECURRENT FIBULAR NERVE AND INFRAPATELLAR BRANCH OF SAPHENOUS NERVE UNDER ULTRASOUND GUIDANCE USING PREDETERMINED ANATOMICAL LADMARKS. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. COMPLAINTS OF KNEE PAIN FOR AT LEAST 6 MONTHS WITH NRS >5/10
2. DIAGNOSED CASES OF CHRONIC OSTEOARTHRITIS OF KNEE ACCORDING TO AMERICAN COLLEGE OF RHEUMATOLOGY CRITERIA
3. GRADE 2-4 OSTEOARTHRITIS ACCORDING TO KELLGREN-LAWRENCE GRADING
4. RECEIVED CONSERVATIVE TREATMENT FOR AT LEAST 3 MONTHS 
 
ExclusionCriteria 
Details  1. GRADE 4 OSTEOARTHRITIS WHO ARE CANDIDATES FOR TKR
2. PREVIOUS SURGICAL INTERVENTION DONE TO THE KNEE JOINT
3. PATIENTS WITH OTHER PATHOLOGY LIKE RHEUMATOID ARTHRITIS
4. PATIENTS WITH PERIPHERAL NEUROPATHY, SAPHENOUS NERVE ENTRAPMENT, RADICULOPATHY.
5. PATIENTS WITH UNCONTROLLED METABOLIC DISEASES LIKE HTN, DM.
6. PATIENTS WITH BLEEDING DIATHESIS
7. PATIENTS WITH SERIOUS NEUROLOGICAL AND PSYCHIATRIC ILLNESS 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
TO COMPARE THE SEVERITY OF PAIN IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE AT BASELINE, AFTER 1 MONTH AND AFTER 3 MONTHS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH USING 11-POINT NUMERICAL RATING SCALE [NRS]  BASELINE
1 MONTH
3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE QUALITY OF LIFE IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE AT BASELINE AND AFTER 3 MONTHS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH USING KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE [KOOS]  BASELINE
3 MONTHS 
TO COMPARE KNEE FUNCTION IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE AT BASELINE AND AFTER 3 MONTHS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH USING TIMED UP AND GO [TUG] TEST  BASELINE
3 MONTHS 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/07/2023 
Date of Study Completion (India) 29/03/2024 
Date of First Enrollment (Global)  03/07/2023 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified 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 - Proposals should be directed to [DRMEGHABHARGAVA95@GMAIL.COM].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2035?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   THIS IS DOUBLE BLINDED RANDOMISED CONTROLLED TRIAL COMPARING THE EFFECTIVENESS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH FOR PAIN AND QUALITY OF LIFE IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE. THE PRIMARY OUTCOME MEASURES THE SEVERITY OF PAIN POST PROCEDURE AT BASELINE, AFTER 1 MONTH AND AFTER 3 MONTHS IN BOTH THE GROUPS USING 11-POINT NRS. THE SECONDARY OUTCOME MEASURES THE QUALITY OF LIFE AND KNEE FUNCTION POST PROCEDURE AT BASELINE AND AFTER 3 MONTHS IN BOTH THE GROUPS USING KOOS AND TUG TEST RESPECTIVELY. THE MEAN SCORES OF BOTH GROUPS WILL BE COMPARED USING APPROPRIATE STATISTICAL METHODS. 
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