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

NCT05219084 | Completed Phase 3

• 1 other identifier: SC 250
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

placebo group

PLACEBO COMPARATOR

5ml of normal; saline-injected subcutaneously

Drug: Control group

Hip denervatiopn

ACTIVE COMPARATOR

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

Drug: hip denervation

Inra-articular hydration

ACTIVE COMPARATOR

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

Drug: intra-articular hydration

compined group

ACTIVE COMPARATOR

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

Drug: Combined group

Interventions

hip denervation DRUG

Lidocaine 2% 2ml was injected into each genicular nerve

Hip denervatiopn

intra-articular hydration DRUG

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

Inra-articular hydration

Combined group DRUG

hip denervation and intra-articular hydration were conducted together

compined group

Control group DRUG

Normal; saline was injected subcutaneously

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead
• Suez Canal University: collaborator

Study Sites (1)

Ahmed Elsaman

Sohag, 82749, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: December 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

EG (1)