Genicular Nerve Block in Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Genicular Nerve Block in Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687930
• Other study ID #: 8122020
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: July 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis
• no Intra-articular Injection in the Last 3 Months
• no Other Cause for Chronic Kneearthritis
• Persistent Knee Arthritis

Intervention

Drug:
• genicular nerve block
nerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound.
• intra-articular steroid injection
Triamcinilone injection into the knee joint under ultrasound guidance.

Locations

Country	Name	City	State
Egypt	Sohag university	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 SOLAR score over time	score to assess ultrasound parameters of the knee including power doppler and grey scale measures	Baseline, 2 weeks and 12 weeks
Primary	Change in visual analogue scale over time	a graded score for pain evaluation filled by the patient graded from 0 to 10	Baseline, 2 weeks and 12 weeks
Primary	Change in Lysholm score over time	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	Baseline, 2 weeks and 12 weeks
Primary	Change in semiquantitative score for swelling and tenderness over time	A score graded from 0 to 3; score 0 means no swelling nor tenderness and 3 means maximum swelling and tenderness	Baseline, 2 weeks and 12 weeks