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OpenTrials
Completed

NCT Number: NCT05219084

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Elsaman

Sohag, 82749, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hip denervation

Drug

Lidocaine 2% 2ml was injected into each genicular nerve

intra-articular hydration

Drug

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

Combined group

Drug

hip denervation and intra-articular hydration were conducted together

Control group

Drug

Normal; saline was injected subcutaneously

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Collaborators

  • Suez Canal University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.