Genicular Nerve Block in Juvenile Idiopathic Arthritis

NCT ID: NCT04687930

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-02-15

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

genicular nerve block

Intervention Type DRUG

nerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound.

intra-articular steroid injection group

while group 2 received intra-articular triamcinolone under ultrasound guidance and through injecting the supra-patellar bursa.

Group Type OTHER

intra-articular steroid injection

Intervention Type DRUG

Triamcinilone injection into the knee joint under ultrasound guidance.

Interventions

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genicular nerve block

nerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound.

Intervention Type DRUG

intra-articular steroid injection

Triamcinilone injection into the knee joint under ultrasound guidance.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahrous

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university

Sohag, , Egypt

Site Status

Countries

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Egypt

References

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Radwan A, Ohrndorf S, Aly H, Hamed M, Khalifa A, Elsaman AM. Genicular nerve block in juvenile idiopathic arthritis: a randomized clinical trial. Clin Rheumatol. 2023 Mar;42(3):879-888. doi: 10.1007/s10067-022-06389-4. Epub 2022 Oct 5.

Reference Type DERIVED
PMID: 36197647 (View on PubMed)

Other Identifiers

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8122020

Identifier Type: -

Identifier Source: org_study_id

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