NCT05942976

Brief Summary

The aim of this study is to investigate the sonographic differences in entheses in patients with Rheumatoid arthritis and Axial Spondyloarthropathy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

29 days

First QC Date

June 27, 2023

Last Update Submit

September 3, 2023

Conditions

Keywords

Axial Spondyloarthritis,Rheumatoid ArthritisEnthesitisUltrasound

Outcome Measures

Primary Outcomes (2)

  • Ultrasound enthesis differences between the groups

    triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores differences between the groups

    2 months

  • The relationship between ultrasound findings and disease parameters

    The relationship between triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores and Clinical disease activity index and BASDAI

    2 months

Study Arms (3)

group 1: axial spondyloarthritis

SpA patients identified according to the Assessment of Spondyloarthritis classification criteria

Other: ULTRASOUND

group 2: Rheumatoid arthritis

RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria

Other: ULTRASOUND

group:3 Healthy Control

healthy controls with no history of rheumatic diseases

Other: ULTRASOUND

Interventions

10 enthesis areas will be evaluated in 20 minutes with ultrasound.

group 1: axial spondyloarthritisgroup 2: Rheumatoid arthritisgroup:3 Healthy Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria, axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria and healthy controls with no history of rheumatic diseases.

You may qualify if:

  • Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria,
  • axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria
  • healthy controls with no history of rheumatic diseases.

You may not qualify if:

  • history of limb trauma and surgery in the last 3 months,
  • metabolic disease (diabetes mellitus, hypothyroidism),
  • malignant neoplasm,
  • limitation of range of motion in the extremity,
  • those who have received corticosteroid injections in the last 3 months,
  • uncontrollable fibromyalgia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Resarch Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Axial SpondyloarthritisArthritis, RheumatoidEnthesopathy

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesTendinopathyMuscular DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 12, 2023

Study Start

June 16, 2023

Primary Completion

July 15, 2023

Study Completion

August 15, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Locations