Genicular Nerve Block in Juvenile Idiopathic Arthritis

July 18, 2021 updated by: Ahmed Mahrous, Sohag University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82749
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active genicular nerve block group
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).
Drug: genicular nerve block
nerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound.
Other: intra-articular steroid injection group
while group 2 received intra-articular triamcinolone under ultrasound guidance and through injecting the supra-patellar bursa.
Drug: intra-articular steroid injection
Triamcinilone injection into the knee joint under ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SOLAR score over time
Time Frame: Baseline, 2 weeks and 12 weeks
score to assess ultrasound parameters of the knee including power doppler and grey scale measures
Baseline, 2 weeks and 12 weeks
Change in visual analogue scale over time
Time Frame: Baseline, 2 weeks and 12 weeks
a graded score for pain evaluation filled by the patient graded from 0 to 10
Baseline, 2 weeks and 12 weeks
Change in Lysholm score over time
Time Frame: 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
Baseline, 2 weeks and 12 weeks
Change in semiquantitative score for swelling and tenderness over time
Time Frame: 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
Baseline, 2 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 18, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8122020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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