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
|
|
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
|
|
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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [DRMEGHABHARGAVA95@GMAIL.COM].
- 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.
- 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. |