- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05119491
Relation Between Pulmonary Function Tests and Ultrasonographic Chest Joints (Ultrasound)
Relation Between Pulmonary Function Tests and Ultrasonographic Changes of Asymptomatic Anterior Chest Wall Joints in Rheumatoid Arthritis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical assessment:
Patients and controls were examined in supine position with elbows placed in contact with the body. The anterior chest wall joints (CWJ) which include the right and left sternoclavicular (SCJ) and manubriosternal (MSJ) joints were evaluated for presence/absence of spontaneous pain, pain evoked by digital pressure, swelling, and redness of skin.
Rheumatoid disease activity was assessed clinically using: disease activity score (DAS28 ESR)] and Functional status assessment by health assessment questionnaire (HAQ) .
Chest expansion was measured with a tape measure placed circumferentially around the chest wall at the fourth intercostal space.
US assessment:
Ultrasonographic B examination (mode and Doppler power mode) of the 3 joints were performed by an experienced rheumatologist. All patients were examined using B-mode (gray scale) real-time MSUS (F37; Hitachi-Aloka, Japan) interfaced with a 10-18-MHz linear array transducer. For each patient and control subject, US examination included a longitudinal section of the left and right SCJ and the MSJ, followed by a cross-section in case erosion was detected. During the examination, synovitis (hypo echoic intracapsular incompressible area with or without Doppler flow), joint effusion (compressible anechoic intracapsular area, absence of Doppler flow), erosion (disruption of the cortical bone line displayed in 2 perpendicular axes), joint space narrowing (reduction of the joint space), ankylosis (complete loss of joint space), or Doppler signal (power Doppler signal) were investigated.
PD parameters were as follow: Pulse repetition frequency (PRF) was adjusted at the lowest permissible value to maximize sensitivity. This setting resulted in PRF from 500 Hz to 750 Hz. Flow was additionally demonstrated in 2 planes and confirmed by pulsed wave Doppler spectrum to exclude artifacts.
Computed Tomography (HRCT) was done on the chest to exclude any interstitial lung disease that may affect chest expansion and restrictive PFTs.
- Pulmonary function tests:
PFTs was done with a Sensormedics Vmax229 system (Sensormedics, Yorba Linda, California, USA) and included measurement of the forced expiratory volume in1 second (FEV1), forced vital capacity (FVC), and the ratio of forced expiratory volume in 1 second to the forced vital capacity(FEV1/FVC).
The study was approved by the Institutional Review Board at the Faculty of Medicine, Zagazig University Hospitals. It has been carried out in accordance with the code of ethics of the world medical association (Declaration of Helsinki 1964) for studies involving humans. A written informed consent was obtained from each participant.
Methods:
Aim: To detect the relation between ultrasonographic changes of asymptomatic ACW joints and pulmonary function tests (PFTs) in patients with RA.
Study design and setting: An observational case control study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Zagazig, Egypt, 44519
- ZagazigU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- rheumatoid arthritis patients
Exclusion Criteria:
- other respiratory diseases
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cases ultra sound and spirometry
observation by ultra sound and spirometry for cases
|
chest uitrasonography and spirometry
|
|
heathy subjects ultra sound and spirometry
observation ultra sound and spirometry for control heathy subjects
|
chest uitrasonography and spirometry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
This study is a trial to find correlation between US detected abnormalities in anterior chest wall joints and (FEV1,FVC,FEV1/FVC ) in Rh A patients
Time Frame: about 2 years
|
observation
|
about 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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