Genicular Nerve Block in Rheuamtoid Arthritis

Phase 4

Completed

• Conditions: Inflammation; Pain; Joint Function Disorder
• Interventions: Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer); Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

• Registration Number: NCT04361513
• Lead Sponsor: Sohag University

Brief Summary

N=64 RA patients either early or established disease diagnosed after ACR/EULAR criteria 2010 with unilateral persistent knee arthritis. They were randomly assigned into two groups; group 1 received genicular nerve block, group 2 intra-articular triamcinolone. Both groups were examined by SOLAR scoring system, Visual analogue scale (VAS) and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score was used to assess tenderness and swelling at the same intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• RA patients
• Age > 18
• unilateral persistent knee arthritis

Exclusion Criteria

• Participants with severe knee osteoarthritis
• peripheral neuropathy
• psoriatic arthritis
• skin infection
• or those who have allergy for Bupivacaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nerve block group	triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)	3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.
Nerve block group	Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)	3 point genicular nerve block under ultrasound guidance. half ml of Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer) was injected in each point.
intra-articular steroid injection	Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)	1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.
intra-articular steroid injection	triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)	1 mL of triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) was injected intraarticular.

Primary Outcome Measures

Name	Time	Method
SOLAR score for inflammation changes by ultrasound	at 0 time after 2 weeks and after 12 weeks	0 means normal and 27 means the worst possible inflammation
Pain changes by VAS	at 0 time after 2 weeks and after 12 weeks	0 means no pain and 10 means the most severe pain
Lysholm score for change in knee function	at 0 time after 2 weeks and after 12 weeks	100 means the best performance and 0 means complete loss of function

Trial Locations

Locations (1)

Minia university; 🇪🇬 Minya, Egypt