Genicular Nerve Block in Juvenile Idiopathic Arthritis

Phase 4

Completed

• Conditions: Persistent Knee Arthritis; Juvenile Idiopathic Arthritis; no Intra-articular Injection in the Last 3 Months; no Other Cause for Chronic Kneearthritis
• Interventions: Drug: genicular nerve block; Drug: intra-articular steroid injection

• Registration Number: NCT04687930
• Lead Sponsor: Sohag University

Brief Summary

N=104 juvenile idiopathic arthritis patients diagnosed after ILAR criteria with unilateral persistent knee arthritis. They will be randomly assigned into two groups; group 1 will receive genicular nerve block, group 2 intra-articular triamcinolone. Both groups will be examined by SOLAR ultrasound scoring system, Visual analogue scale and Lysholm score at 0, 2 and 12 weeks. A semi-quantitative score will be used to assess tenderness and swelling at the same intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• juvenile idiopathic arthritis with persistent knee arthritis
• age below 16

Exclusion Criteria

• severe knee osteoarthritis
• peripheral neuropathy,
• psoriatic arthritis,
• those under anticoagulant therapy, skin infection,
• prior knee injection in the last 3 months3
• those who have an allergy to Bupivacaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active genicular nerve block group	genicular nerve block	group 1 will receive genicular nerve block. The injection and US examination will be done by two experienced sonographers. They were blinded to clinical data. Patients will also be blinded for the injected substance. Each point will be injected with 2 ml of Lidocaine hydrochloride 2 % (Xylocaine, Astrazeneca). The injection will be done using the 3 point technique (superior medial, superior lateral, and inferior medial genicular nerves).
intra-articular steroid injection group	intra-articular steroid injection	while group 2 received intra-articular triamcinolone under ultrasound guidance and through injecting the supra-patellar bursa.

Primary Outcome Measures

Name	Time	Method
Change in visual analogue scale over time	Baseline, 2 weeks and 12 weeks	a graded score for pain evaluation filled by the patient graded from 0 to 10
Change in Lysholm score over time	Baseline, 2 weeks and 12 weeks	a score to assess knee function. This questionnaire has 8 domains. A score between 95 and 100 means excellent functional performance, good 84-94, fair 65-83 and poor \<64
Change in semiquantitative score for swelling and tenderness over time	Baseline, 2 weeks and 12 weeks	A score graded from 0 to 3; score 0 means no swelling nor tenderness and 3 means maximum swelling and tenderness
Change in SOLAR score over time	Baseline, 2 weeks and 12 weeks	score to assess ultrasound parameters of the knee including power doppler and grey scale measures

Trial Locations

Locations (1)

Sohag university; 🇪🇬 Sohag, Egypt