Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT04775225

Collaborator

(none)

120

Enrollment

Location

Arms

Actual Duration (Months)

40.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis Hip Arthritis	Drug: Lidocaine Drug: Placebo Drug: Steroid	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double-blinded

Primary Purpose:

Treatment

Official Title:

Hip Denervation in Juvenile Idiopathic Arthritis

Actual Study Start Date :

Jan 6, 2021

Actual Primary Completion Date :

Apr 6, 2021

Actual Study Completion Date :

Apr 6, 2021

Arms and Interventions

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 receive an intra-articular injection of 40mg triamcinolone	Drug: Steroid Intra-articular injection of 40mg of triamcinolone Other Names: The active steroid 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 receive an intra-articular injection of 40mg triamcinolone

Drug: Steroid

Intra-articular injection of 40mg of triamcinolone

Other Names:

The active steroid group

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ahmed Elsaman	Sohag		Egypt	82749

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mahrous, Associate professor, Sohag University

ClinicalTrials.gov Identifier:

NCT04775225

Other Study ID Numbers:

3012020

First Posted:

Mar 1, 2021

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Juvenile

Lidocaine

Study Results

No Results Posted as of Jun 24, 2022