Rheumatoid ArthritisNCT05999266
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Knee Pain Chronic, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Rheumatoid Arthritis, Knee Pain Chronic, Muscle Loss
- What is being tested?
- Ultrasonographic Measurements
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2023to 12 Nov 2023
- How long will I take part?
- 1 Week
- 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 30 to 50 years
- Women only
- Adult
Study population: Patients with Rheumatoid Arthritis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: 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.
- Being tested
- Ultrasonographic Measurements
- Medical subject headings
- Arthritis, Rheumatoid, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic MeasurementsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultrasonographic Measurements | |
| 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. Receives: Diagnostic Test: Ultrasonographic Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Cartilage Thickness Measurement
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.
Measured: through study completion, an average of 1 month
Ultrasonographic Muscle Measurement Thickness Measurement
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.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start28 Sep 2023
- Primary completion10 Nov 2023
- Study completion12 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999266
- Sponsor's protocol ID
- 15082023
- Status last verified
- Nov 2023
- First submitted
- 13 Aug 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasonographic Cartilage Thickness and Quadriceps/Hamstring Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05999266
- Acronym / sponsor ID
- 15082023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 12 Nov 2023 (actual)
- First posted
- 21 Aug 2023 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Patients with Knee Pain | – | Diagnostic Test: Ultrasonographic MeasurementsIn 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. |
| Rheumatoid Arthritis Patients without Knee Pain | – | Diagnostic Test: Ultrasonographic MeasurementsIn 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients with Rheumatoid Arthritis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Patient with active arthritis or high disease activity
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 |
|---|---|---|
| Ultrasonographic MeasurementsIn 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. | Diagnostic test | Rheumatoid Arthritis Patients with Knee Pain, Rheumatoid Arthritis Patients without Knee Pain |
Primary outcome
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.
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.
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 21 Nov 2023.
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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 Rheumatoid Arthritis and Knee Pain Chronic, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 21 Nov 2023. 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 Turkey (Türkiye). 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?
Ultrasonographic Cartilage Thickness Measurement (time frame: through study completion, an average of 1 month). The study lists 2 primary outcomes in all. 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 21 Nov 2023.