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Genicular Nerve Block in Juvenile Idiopathic Arthritis

Primary Purpose

Juvenile Idiopathic Arthritis, Persistent Knee Arthritis, no Intra-articular Injection in the Last 3 Months

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
genicular nerve block
intra-articular steroid injection
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Juvenile rheumatoid arthritis, knee joint, Nerve block

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sohag university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Active genicular nerve block group

intra-articular steroid injection group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Change in SOLAR score over time
score to assess ultrasound parameters of the knee including power doppler and grey scale measures
Change in visual analogue scale over time
a graded score for pain evaluation filled by the patient graded from 0 to 10
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
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

Secondary Outcome Measures

Full Information

First Posted
December 19, 2020
Last Updated
July 18, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04687930
Brief Title
Genicular Nerve Block in Juvenile Idiopathic Arthritis
Official Title
Genicular Nerve Block in Juvenile Idiopathic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active genicular nerve block group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
intra-articular steroid injection group
Arm Type
Other
Arm Description
while group 2 received intra-articular triamcinolone under ultrasound guidance and through injecting the supra-patellar bursa.
Intervention Type
Drug
Intervention Name(s)
genicular nerve block
Intervention Description
nerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound.
Intervention Type
Drug
Intervention Name(s)
intra-articular steroid injection
Intervention Description
Triamcinilone injection into the knee joint under ultrasound guidance.
Primary Outcome Measure Information:
Title
Change in SOLAR score over time
Description
score to assess ultrasound parameters of the knee including power doppler and grey scale measures
Time Frame
Baseline, 2 weeks and 12 weeks
Title
Change in visual analogue scale over time
Description
a graded score for pain evaluation filled by the patient graded from 0 to 10
Time Frame
Baseline, 2 weeks and 12 weeks
Title
Change in Lysholm score over time
Description
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
Time Frame
Baseline, 2 weeks and 12 weeks
Title
Change in semiquantitative score for swelling and tenderness over time
Description
A score graded from 0 to 3; score 0 means no swelling nor tenderness and 3 means maximum swelling and tenderness
Time Frame
Baseline, 2 weeks and 12 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sohag university
City
Sohag
ZIP/Postal Code
82749
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
36197647
Citation
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.
Results Reference
derived

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Genicular Nerve Block in Juvenile Idiopathic Arthritis

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