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NCT04775225 Clinical Trial

Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

Official title:
Hip Denervation in Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04775225
Other study ID # 3012020
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 6, 2021
Est. completion date April 6, 2021

Study information
Verified date January 2023
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 6, 2021
Est. primary completion date April 6, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine
denervation of the obturator and femoral genicular branches by Lidocaine 2 %
• Placebo
an equivalent amount of saline will be injected subcutaneously in 2 points similar to the active group
• Steroid
Intra-articular injection of 80mg of triamcinolone

Locations
Country Name City State
Egypt ahmed Elsaman Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

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