Targetting nerves supplying the knee joint for the treatment of Osteoarthritis of Knee

Phase 2/3

Completed

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2023/06/054401
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Study Completion: 2024-03-29
• Last Update Posted: 2024-04-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• PATIENTS WITH BLEEDING DIATHESIS 7.
• PATIENTS WITH SERIOUS NEUROLOGICAL AND PSYCHIATRIC ILLNESS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR; 🇮🇳 Jodhpur, RAJASTHAN, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

🇮🇳Jodhpur, RAJASTHAN, India

MEGHA BHARGAVA

Principal investigator

9811921802

meghabhargava@outlook.in