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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients With Axial SpA According to ASAS Criteria, Patients With Unilateral or Bilater Hip Damage According to BASRI Score, Age > 18

Intervention / Treatment
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* Drug: hip denervation
* Drug: intra-articular hydration
* Drug: Combined group
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>5ml of normal; saline-injected subcutaneously | Drug: Control group<br>* Normal; saline was injected subcutaneously<br>|
| Active Comparator: Hip denervatiopn<br>Hip denervation with lidocaine 2% to each genicular branch, 2ml at each point | Drug: hip denervation<br>* Lidocaine 2% 2ml was injected into each genicular nerve<br>|
| Active Comparator: Inra-articular hydration<br>10 ml of normal saline injected inside the hip under ultrasound guidance | Drug: intra-articular hydration<br>* 10 ml; of normal; saline were injected inside the hip joint<br>|
| Active Comparator: compined group<br>hip denervation and intra-articular hydration were conducted together in this group | Drug: Combined group<br>* hip denervation and intra-articular hydration were conducted together<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual analogue scale | 0 means no pain, 100 means the highest degree of pain | Baseline , after 4 weeks and after 12 weeks | 
| Change in Harris functional hip score | 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 | Baseline, after 4 weeks and after 12 weeks | 
| Change in range of motion of the hip | hip flexion, extension , internal; rotation , external; rotation , abduction , and adduction all were recopreded | Baseline, after 4 weeks and after 12 weeks | 
| Change in semiquantitative tenderness score | a score from 0-3, 90 means no tenderness and 3 means maximum tenderness | Baseline, after 4 weeks and after 12 weeks |