NCT05999266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 28, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

August 13, 2023

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    through study completion, an average of 1 month

Study Arms (2)

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

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

Interventions

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 with Knee PainRheumatoid Arthritis Patients without Knee Pain

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Rheumatoid Arthritis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, RheumatoidMuscular Atrophy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 21, 2023

Study Start

September 28, 2023

Primary Completion

November 10, 2023

Study Completion

November 12, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations