- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05999266
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
November 20, 2023 updated by: Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
The Effect of Ultrasonographic Cartilage Thickness and Quadriceps/Hamstring Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
The knee pain status of the patients who are followed in the rheumatology special branch of the Physical Medicine and Rehabilitation Outpatient Clinic and who meet the inclusion criteria will be questioned.
In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound.
At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
The physician who performed the ultrasonographic measurements of the knee pain status of the patients does not know.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients with Rheumatoid Arthritis
Description
Inclusion Criteria:
- Rheumatoid Arthritis > Diagnosed for 1 year
- -Female gender
- -The patient has been in remission or low disease activity for at least 3 months
- -Be able to ambulatory
- -No significant deformity in the lower extremity joints
Exclusion Criteria:
Patient with active arthritis or high disease activity
- - Significant deformity of the lower extremity joints and inability to ambulate
- -Pregnant patient
- - Presence of malignancy
- - Patient with a severe psychiatric disorder and difficulty in cooperation
- - Presence of cardiovascular and pulmonary comorbidities that will prevent exercise
- -Male gender
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Rheumatoid Arthritis Patients with Knee Pain
In patients with knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound.
At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
|
In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound.
At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
|
|
Rheumatoid Arthritis Patients without Knee Pain
In patients without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound.
At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
|
In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound.
At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasonographic Cartilage Thickness Measurement
Time Frame: through study completion, an average of 1 month
|
Tibial cartilage thickness will be visualized by ultrasound with the knee held in 30 degrees of flexion, and 3 measurements will be taken from the medial, lateral and midline.
|
through study completion, an average of 1 month
|
|
Ultrasonographic Muscle Measurement Thickness Measurement
Time Frame: through study completion, an average of 1 month
|
The quadriceps muscle thickness will be measured by determining the midpoint between the SIAS and the patella while the patient is lying in the supine position.
Hamstring muscle thickness will be measured at the intersection of a line drawn at 60% distal between the greater trochanter and the outer femoral condyle, and at the midline of the popliteal fossa, with the patient lying on the prone.
These 2 measurements will be proportional to each other.
|
through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2023
Primary Completion (Actual)
November 10, 2023
Study Completion (Actual)
November 12, 2023
Study Registration Dates
First Submitted
August 13, 2023
First Submitted That Met QC Criteria
August 13, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15082023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.