Osteoarthritis Clinical Trial
Official title:
Evaluation of the Relationship Between the Architecture of the Quadriceps, Tibialis Anterior and Gastrocnemius Muscles and Muscle Strength in Female Gonarthrosis Patients
NCT number | NCT06003413 |
Other study ID # | 2020/162 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 24, 2023 |
Est. completion date | October 1, 2023 |
The goal of this cross-sectional study is to evaluate muscle architecture changes and it's effect on muscle strength in female patients with gonarthrosis.Main questions are: - Is there any correlation between muscle strength and muscle thickness, pennation angle fiber length? - Is there any muscle architecture difference in gonarthrosis and is it effecting the muscle strength? The investigators will enroll patients with unilateral gonarthrosis so that investigators can compare the changes within osteoarthritic and healthy knee with the same physical activity levels.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 1, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - To be =18 years of age, - Presence of unilateral knee OA (according to American College of Rheumatology criteria), - Presence of knee OA with Kellgren/Lawrence (K/L) stage =2, - Ability to live independently, - Ability to walk without assistive devices. Exclusion Criteria: - History of surgery on the spine or lower extremities, - History of inflammatory rheumatic disease, - Severe cardiovascular disease, - Neuromuscular disease affecting muscle strength, - Individuals following a regular exercise program, - Secondary osteoarthritis. |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Rating Scale | Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome. | 1 day | |
Primary | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was created to assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis (OA).
The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items): Stiffness (2 items): Physical Function (17 items) Number of items in scale: 24 items The WOMAC is available in 5-point Likert-type and 100mm Visual Analog formats |
1 day | |
Primary | Isometric Knee Extension Muscle Strength | Isometric Knee Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms. | 1 day | |
Primary | Isometric Ankle Dorsiflexion Muscle Strength | Isometric Ankle Dorsiflexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms. | 1 day | |
Primary | Isometric Ankle Plantar Flexion Muscle Strength | Isometric Ankle Plantar Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms. | 1 day | |
Primary | Health Assessment Questionnaire (HAQ) | The Health assessment questionnaire (HAQ) is a questionnaire for the assessment of disability in an individual. The patients report the amount of difficulty they have in performing eight daily living activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The final score varies between 0 and 3. | 1 day | |
Primary | Outcome Measures in Rheumatology (OMERACT) ultrasound scores for knee osteoarthritis (OA) | The US scores for 7 disease manifestations were then graded by the same operator using the OMERACT knee US OA atlas: semiquantitative scores for (1) synovitis (0-3; combined synovial hypertrophy and effusion); (2) binary scores (0-1) for synovial hypertrophy = 4 mm, (3) effusion = 4 mm12; and (4) Power Doppler (PD) signals separate from suprapatellar recess in a longitudinal plane, medial and lateral parapatellar recesses in a transverse plane, semiquantitative scores for (5) osteophytes (0-3) from the medial and lateral joint aspects in a longitudinal plane and (6) meniscal extrusion (0-2; only the medial joint aspects) in a longitudinal plane, and for (7) cartilage abnormalities (0-3) in a transverse plane on a maximally flexed knee | 1 day |
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