Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

Phase 3

Completed

• Conditions: Juvenile Idiopathic Arthritis; Hip Arthritis
• Interventions: Drug: Steroid; Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT04775225
• Lead Sponsor: Sohag University

Brief Summary

Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. Outcome measures included pain, tenderness, range of motion, SOLAR, HARISS score. These outcomes were measured at baseline, 2 weeks, and 16 weeks

Detailed Description

The aim of the study is to test the effect of denervation of the active hip in JIA and compare it with a placebo without changing systemic treatment during the study. Outcome measures included pain, range of motion, SOLAR score, and Harris functional score.

Study Timeline

• Study Start: 2021-01-06
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients with JIA with unilateral hip arthritis

Exclusion Criteria

• hip involvement due to other causes including
• septic arthritis
• other connective tissue diseases
• Avascular necrosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid	Steroid	This group with receiving an intra-articular injection of 80mg triamcinolone
control group	Placebo	this group will receive saline injection subcutaneously at the same places.
Hip denervation group	Lidocaine	This group will receive Lidocaine 2% block of the femoral and obturator genicular branches.

Primary Outcome Measures

Name	Time	Method
Change in visual analogue scale	Baseline, 2 weeks and 16 weeks	a scale from 0-100 will be used 0 means no pain 100 means the maximum pain
Change in range of motion	Baseline, 2 weeks and 16 weeks	flexion, internal rotation, external rotation range will be calculated
Change in Harris functional score	Baseline, 2 weeks and 16 weeks	100 means best results and 0 means worst results
semiquantitative tenderness score	Baseline, 2 weeks and 16 weeks	0 means no tenderness and 3 means maximum tenderness
Change in SOLAR score	Baseline, 2 weeks and 16 weeks	GSUS. 0 means the least synovitis and the maximum, PDUS, o means no PD and 3 the maximum

Trial Locations

Locations (1)

ahmed Elsaman; 🇪🇬 Sohag, Egypt