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

NCT ID: NCT05219084

Last Updated: 2022-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-04-15

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.

Detailed Description

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo group

5ml of normal; saline-injected subcutaneously

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type DRUG

Normal; saline was injected subcutaneously

Hip denervatiopn

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

Group Type ACTIVE_COMPARATOR

hip denervation

Intervention Type DRUG

Lidocaine 2% 2ml was injected into each genicular nerve

Inra-articular hydration

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

Group Type ACTIVE_COMPARATOR

intra-articular hydration

Intervention Type DRUG

10 ml; of normal; saline were injected inside the hip joint

compined group

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

Group Type ACTIVE_COMPARATOR

Combined group

Intervention Type DRUG

hip denervation and intra-articular hydration were conducted together

Interventions

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Combined group

hip denervation and intra-articular hydration were conducted together

Intervention Type DRUG

Control group

Normal; saline was injected subcutaneously

Intervention Type DRUG

hip denervation

Lidocaine 2% 2ml was injected into each genicular nerve

Intervention Type DRUG

intra-articular hydration

10 ml; of normal; saline were injected inside the hip joint

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suez Canal University

OTHER

Sponsor Role collaborator

Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahrous

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Elsaman

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SC 250

Identifier Type: -

Identifier Source: org_study_id

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