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

April 29, 2022 updated by: Ahmed Mahrous, Sohag University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82749
        • Ahmed Elsaman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual analogue scale
Time Frame: Baseline , after 4 weeks and after 12 weeks
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
Time Frame: 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
Baseline, after 4 weeks and after 12 weeks
Change in range of motion of the hip
Time Frame: Baseline, after 4 weeks and after 12 weeks
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
Time Frame: Baseline, after 4 weeks and after 12 weeks
a score from 0-3, 90 means no tenderness and 3 means maximum tenderness
Baseline, after 4 weeks and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC 250

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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