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Completed

NCT Number: NCT04687930

Genicular Nerve Block in Juvenile Idiopathic Arthritis

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Persistent Knee Arthritis Rheumatic Diseases Skin and Connective Tissue Diseases no Intra-articular Injection in the Last 3 Months no Other Cause for Chronic Kneearthritis

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sohag university

Sohag, 82749, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

genicular nerve block

Drug

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

intra-articular steroid injection

Drug

Triamcinilone injection into the knee joint under ultrasound guidance.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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