The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05999266
Recruitment Status : Completed
First Posted : August 21, 2023
Last Update Posted : November 21, 2023
Sponsor:
Information provided by (Responsible Party):
Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Knee Pain Chronic Muscle Loss Cartilage Degeneration Diagnostic Test: Ultrasonographic Measurements

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 130 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Week
Official Title: The Effect of Ultrasonographic Cartilage Thickness and Quadriceps/Hamstring Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Actual Study Start Date : September 28, 2023
Actual Primary Completion Date : November 10, 2023
Actual Study Completion Date : November 12, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Diagnostic Test: Ultrasonographic Measurements
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.
 Diagnostic Test: Ultrasonographic Measurements
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Rheumatoid Arthritis
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05999266


Locations
Layout table for location information
Turkey
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Aylin Ayyıldız, Medical Doctor, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05999266    
Other Study ID Numbers: 15082023
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: November 21, 2023
Last Verified: November 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases