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OpenTrials
Completed

NCT Number: NCT04775225

Hip Denervation in Juvenile Idiopathic Arthritis With Hip 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

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ahmed Elsaman

Sohag, 82749, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Other names: The active denervation group

Placebo

Drug

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

Other names: The control group

Steroid

Drug

Intra-articular injection of 80mg of triamcinolone

Other names: The active steroid group

Primary outcomes

  1. 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

  2. Change in range of motion

    Time frame: Baseline, 2 weeks and 16 weeks

    flexion, internal rotation, external rotation range will be calculated

  3. Change in Harris functional score

    Time frame: Baseline, 2 weeks and 16 weeks

    100 means best results and 0 means worst results

  4. semiquantitative tenderness score

    Time frame: Baseline, 2 weeks and 16 weeks

    0 means no tenderness and 3 means maximum tenderness

  5. 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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Hip Denervation in Juvenile Idiopathic Arthritis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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