Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

January 13, 2023 updated by: Ahmed Mahrous, Sohag University

Hip Denervation in Juvenile Idiopathic Arthritis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82749
        • Ahmed Elsaman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hip denervation group
This group will receive Lidocaine 2% block of the femoral and obturator genicular branches.
Drug: Lidocaine
denervation of the obturator and femoral genicular branches by Lidocaine 2 %
Other Names:
  • The active denervation group
Placebo Comparator: control group
this group will receive saline injection subcutaneously at the same places.
Drug: Placebo
an equivalent amount of saline will be injected subcutaneously in 2 points similar to the active group
Other Names:
  • The control group
Active Comparator: Steroid
This group with receiving an intra-articular injection of 80mg triamcinolone
Drug: Steroid
Intra-articular injection of 80mg of triamcinolone
Other Names:
  • The active steroid group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual analogue scale
Time Frame: Baseline, 2 weeks and 16 weeks
a scale from 0-100 will be used 0 means no pain 100 means the maximum pain
Baseline, 2 weeks and 16 weeks
Change in range of motion
Time Frame: Baseline, 2 weeks and 16 weeks
flexion, internal rotation, external rotation range will be calculated
Baseline, 2 weeks and 16 weeks
Change in Harris functional score
Time Frame: Baseline, 2 weeks and 16 weeks
100 means best results and 0 means worst results
Baseline, 2 weeks and 16 weeks
semiquantitative tenderness score
Time Frame: Baseline, 2 weeks and 16 weeks
0 means no tenderness and 3 means maximum tenderness
Baseline, 2 weeks and 16 weeks
Change in SOLAR score
Time Frame: Baseline, 2 weeks and 16 weeks
GSUS. 0 means the least synovitis and the maximum, PDUS, o means no PD and 3 the maximum
Baseline, 2 weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Actual)

April 6, 2021

Study Completion (Actual)

April 6, 2021

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3012020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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