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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
hip denervation
intra-articular hydration
Combined group
Control group
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Axial SpA According to ASAS Criteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ahmed Elsaman

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

placebo group

Hip denervatiopn

Inra-articular hydration

compined group

Arm Description

5ml of normal; saline-injected subcutaneously

Hip denervation with lidocaine 2% to each genicular branch, 2ml at each point

10 ml of normal saline injected inside the hip under ultrasound guidance

hip denervation and intra-articular hydration were conducted together in this group

Outcomes

Primary Outcome Measures

Change in visual analogue scale
0 means no pain, 100 means the highest degree of pain
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
Change in range of motion of the hip
hip flexion, extension , internal; rotation , external; rotation , abduction , and adduction all were recopreded
Change in semiquantitative tenderness score
a score from 0-3, 90 means no tenderness and 3 means maximum tenderness

Secondary Outcome Measures

Full Information

First Posted
January 20, 2022
Last Updated
April 29, 2022
Sponsor
Sohag University
Collaborators
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05219084
Brief Title
Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients
Official Title
Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
Collaborators
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Axial SpA According to ASAS Criteria, Patients With Unilateral or Bilater Hip Damage According to BASRI Score, Age > 18

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
5ml of normal; saline-injected subcutaneously
Arm Title
Hip denervatiopn
Arm Type
Active Comparator
Arm Description
Hip denervation with lidocaine 2% to each genicular branch, 2ml at each point
Arm Title
Inra-articular hydration
Arm Type
Active Comparator
Arm Description
10 ml of normal saline injected inside the hip under ultrasound guidance
Arm Title
compined group
Arm Type
Active Comparator
Arm Description
hip denervation and intra-articular hydration were conducted together in this group
Intervention Type
Drug
Intervention Name(s)
hip denervation
Intervention Description
Lidocaine 2% 2ml was injected into each genicular nerve
Intervention Type
Drug
Intervention Name(s)
intra-articular hydration
Intervention Description
10 ml; of normal; saline were injected inside the hip joint
Intervention Type
Drug
Intervention Name(s)
Combined group
Intervention Description
hip denervation and intra-articular hydration were conducted together
Intervention Type
Drug
Intervention Name(s)
Control group
Intervention Description
Normal; saline was injected subcutaneously
Primary Outcome Measure Information:
Title
Change in visual analogue scale
Description
0 means no pain, 100 means the highest degree of pain
Time Frame
Baseline , after 4 weeks and after 12 weeks
Title
Change in Harris functional hip score
Description
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
Time Frame
Baseline, after 4 weeks and after 12 weeks
Title
Change in range of motion of the hip
Description
hip flexion, extension , internal; rotation , external; rotation , abduction , and adduction all were recopreded
Time Frame
Baseline, after 4 weeks and after 12 weeks
Title
Change in semiquantitative tenderness score
Description
a score from 0-3, 90 means no tenderness and 3 means maximum tenderness
Time Frame
Baseline, after 4 weeks and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ahmed Elsaman
City
Sohag
ZIP/Postal Code
82749
Country
Egypt

12. IPD Sharing Statement

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

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