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Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

Primary Purpose

Juvenile Idiopathic Arthritis, Hip Arthritis

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Lidocaine

Placebo

Steroid

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with JIA with unilateral hip arthritis

Exclusion Criteria:

hip involvement due to other causes including
septic arthritis
other connective tissue diseases
Avascular necrosis

Sites / Locations

ahmed Elsaman

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Hip denervation group

control group

Steroid

Arm Description

This group will receive Lidocaine 2% block of the femoral and obturator genicular branches.

this group will receive saline injection subcutaneously at the same places.

This group with receiving an intra-articular injection of 80mg triamcinolone

Outcomes

Primary Outcome Measures

Change in visual analogue scale

a scale from 0-100 will be used 0 means no pain 100 means the maximum pain

Change in range of motion

flexion, internal rotation, external rotation range will be calculated

Change in Harris functional score

100 means best results and 0 means worst results

semiquantitative tenderness score

0 means no tenderness and 3 means maximum tenderness

Change in SOLAR score

GSUS. 0 means the least synovitis and the maximum, PDUS, o means no PD and 3 the maximum

Secondary Outcome Measures

Full Information

NCT ID

NCT04775225

First Posted

February 17, 2021

Last Updated

January 13, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04775225

Brief Title

Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

Official Title

Hip Denervation in Juvenile Idiopathic Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 6, 2021 (Actual)

Primary Completion Date

April 6, 2021 (Actual)

Study Completion Date

April 6, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. Outcome measures included pain, tenderness, range of motion, SOLAR, HARISS score. These outcomes were measured at baseline, 2 weeks, and 16 weeks

Detailed Description

The aim of the study is to test the effect of denervation of the active hip in JIA and compare it with a placebo without changing systemic treatment during the study. Outcome measures included pain, range of motion, SOLAR score, and Harris functional score.

6. Conditions and Keywords

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

Juvenile Idiopathic Arthritis, Hip Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

double-blinded

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hip denervation group

Arm Type

Active Comparator

Arm Description

This group will receive Lidocaine 2% block of the femoral and obturator genicular branches.

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

this group will receive saline injection subcutaneously at the same places.

Arm Title

Steroid

Arm Type

Active Comparator

Arm Description

This group with receiving an intra-articular injection of 80mg triamcinolone

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

The active denervation group

Intervention Description

denervation of the obturator and femoral genicular branches by Lidocaine 2 %

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

The control group

Intervention Description

an equivalent amount of saline will be injected subcutaneously in 2 points similar to the active group

Intervention Type

Drug

Intervention Name(s)

Steroid

Other Intervention Name(s)

The active steroid group

Intervention Description

Intra-articular injection of 80mg of triamcinolone

Primary Outcome Measure Information:

Title

Change in visual analogue scale

Description

a scale from 0-100 will be used 0 means no pain 100 means the maximum pain

Time Frame