Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients

Phase 3

Completed

• Conditions: Patients With Axial SpA According to ASAS Criteria; Patients With Unilateral or Bilater Hip Damage According to BASRI Score; Age > 18
• Interventions: Drug: hip denervation; Drug: Combined group; Drug: Control group; Drug: intra-articular hydration

• Registration Number: NCT05219084
• Lead Sponsor: Sohag University

Brief Summary

Background: The hip joint is frequently affected in axial spondyloarthritis (SpA) of adults with destructive effects in untreated patients. About 35% of axial SpA patients had either unilateral or bilateral hip arthritis. Destruction is more common with early-onset, active disease, or enthesitis.

Objectives: The aim of this study is to evaluate the effect of hip denervation (HD) and intra-articular hydration (IAH) on pain, function score, hip mobility scores in a cohort of axial SpA patients with grade 3 and 4 hip BASRI scores.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age 18 or more
• Axial; SpA fulfilled ASA criteria
• BASRI score grade 3 or 4 for one hip at least

Exclusion Criteria

• patients younger than 18
• Axial; SpA with normal hip or hip involvement less than 3 on BASRI score

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hip denervatiopn	hip denervation	Hip denervation with lidocaine 2% to each genicular branch, 2ml at each point
compined group	Combined group	hip denervation and intra-articular hydration were conducted together in this group
placebo group	Control group	5ml of normal; saline-injected subcutaneously
Inra-articular hydration	intra-articular hydration	10 ml of normal saline injected inside the hip under ultrasound guidance

Primary Outcome Measures

Name	Time	Method
Change in Harris functional hip score	Baseline, after 4 weeks and after 12 weeks	Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points).; The higher the HHS, the less dysfunction. A total score of \<70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result
Change in range of motion of the hip	Baseline, after 4 weeks and after 12 weeks	hip flexion, extension , internal; rotation , external; rotation , abduction , and adduction all were recopreded
Change in semiquantitative tenderness score	Baseline, after 4 weeks and after 12 weeks	a score from 0-3, 90 means no tenderness and 3 means maximum tenderness
Change in visual analogue scale	Baseline , after 4 weeks and after 12 weeks	0 means no pain, 100 means the highest degree of pain

Trial Locations

Locations (1)

Ahmed Elsaman; 🇪🇬 Sohag, Egypt