Restrictive Lung DiseaseUltrasoundNCT05119491
Relation Between Pulmonary Function Tests and Ultrasonographic Chest Joints
An observational study of Restrictive Lung Disease, run by Zagazig University at 1 site in Egypt.
Trial summary
Ultrasonography can detect different changes in anterior chest wall (ACW) joints in patients with Rheumatoid arthritis (RA) even before being clinically manifested. Airways ,pleura, lung parenchyma and vascular compartment all may be attacked by RA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restrictive Lung Disease
- What is being tested?
- uitrasonography and spirometry
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 21 Mar 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: rheumatoid arthritis patients
Who may be able to join
- rheumatoid arthritis patients
Who cannot join
- other respiratory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Pulmonary Function Tests and Ultrasonographic Changes of Asymptomatic Anterior Chest Wall Joints in Rheumatoid Arthritis Patients
Ultrasonography can detect different changes in anterior chest wall (ACW) joints in patients with Rheumatoid arthritis (RA) even before being clinically manifested. Airways ,pleura, lung parenchyma and vascular compartment all may be attacked by RA. This study was aiming at detecting the relation between ultrasonographic changes of asymptomatic ACW joints and pulmonary function tests (PFTs) in patients with RA.
Read the 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.
- Conditions
- Restrictive Lung Disease
- Being tested
- uitrasonography and spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uitrasonography and spirometryDevice
chest uitrasonography and spirometry
| Study group | Role | What they receive |
|---|---|---|
| cases ultra sound and spirometry | observation by ultra sound and spirometry for cases Receives: Device: uitrasonography and spirometry | |
| heathy subjects ultra sound and spirometry | observation ultra sound and spirometry for control heathy subjects Receives: Device: uitrasonography and spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
observation
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jan 2019
- Primary completion30 Dec 2020
- Study completion21 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restrictive Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Waleed Mansour, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119491
- Sponsor's protocol ID
- 7039
- Acronym
- Ultrasound
- Status last verified
- Jan 2025
- First submitted
- 7 Oct 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: research
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Pulmonary Function Tests and Ultrasonographic Changes of Asymptomatic Anterior Chest Wall Joints in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05119491
- Acronym / sponsor ID
- Ultrasound / 7039
- Conditions
- Restrictive Lung Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 21 Mar 2021 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultrasonography can detect different changes in anterior chest wall (ACW) joints in patients with Rheumatoid arthritis (RA) even before being clinically manifested. Airways ,pleura, lung parenchyma and vascular compartment all may be attacked by RA. This study was aiming at detecting the relation between ultrasonographic changes of asymptomatic ACW joints and pulmonary function tests (PFTs) in patients with RA.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases ultra sound and spirometry | – | Device: uitrasonography and spirometryobservation by ultra sound and spirometry for cases |
| heathy subjects ultra sound and spirometry | – | Device: uitrasonography and spirometryobservation ultra sound and spirometry for control heathy subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- rheumatoid arthritis patients
Key inclusion criteria (1 listed)
- rheumatoid arthritis patients
Key exclusion criteria (1 listed)
- other respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uitrasonography and spirometrychest uitrasonography and spirometry | Device | cases ultra sound and spirometry, heathy subjects ultra sound and spirometry |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided. research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restrictive Lung Disease, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.