Genicular Nerve Block in Juvenile Idiopathic Arthritis

NCT04687930 | Completed Phase 4 DMC

• 1 other identifier: 8122020
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Juvenile rheumatoid arthritis; knee joint; Nerve block

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Active genicular nerve block group

ACTIVE COMPARATOR

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

intra-articular steroid injection group

OTHER

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

Drug: intra-articular steroid injection

Interventions

genicular nerve block DRUG

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

Active genicular nerve block group

intra-articular steroid injection DRUG

Triamcinilone injection into the knee joint under ultrasound guidance.

intra-articular steroid injection group

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• juvenile idiopathic arthritis with persistent knee arthritis
• age below 16

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, 82749, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36197647 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Steroids

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 29, 2020
• Study Start: December 1, 2020
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

EG (1)