Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis

NCT04775225 | Completed Phase 3 DMC

• 1 other identifier: 3012020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Juvenile Idiopathic Arthritis; Hip Arthritis

Outcome Measures

Primary Outcomes (5)

• Change in visual analogue scale

  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

  flexion, internal rotation, external rotation range will be calculated

  Baseline, 2 weeks and 16 weeks

• Change in Harris functional score

  100 means best results and 0 means worst results

  Baseline, 2 weeks and 16 weeks

• semiquantitative tenderness score

  0 means no tenderness and 3 means maximum tenderness

  Baseline, 2 weeks and 16 weeks

• Change in SOLAR score

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

  Baseline, 2 weeks and 16 weeks

Study Arms (3)

Hip denervation group

ACTIVE COMPARATOR

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

Drug: Lidocaine

control group

PLACEBO COMPARATOR

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

Drug: Placebo

Steroid

ACTIVE COMPARATOR

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

Drug: Steroid

Interventions

Lidocaine DRUG

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

Also known as: The active denervation group

Hip denervation group

Placebo DRUG

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

Also known as: The control group

control group

Steroid DRUG

Intra-articular injection of 80mg of triamcinolone

Also known as: The active steroid group

Steroid

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients with JIA with unilateral hip arthritis

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

ahmed Elsaman

Sohag, 82749, Egypt

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Lidocaine; Steroids

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 1, 2021
• Study Start: January 6, 2021
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

EG (1)