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NCT Number: NCT06003413

Evaluation of the Relationship Between Muscle Architecture and Muscle Strength in Female Gonarthrosis Patients

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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Gonarthrosis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

Knee osteoarthritis (OA) is a chronic disease characterized by morning stiffness, reduced joint range of motion, chronic pain, and decreased muscle strength, leading to functional limitations as the disease progresses . In patients with knee osteoarthritis, all muscles of the hip, knee, and ankle are affected in some way . Evidence suggests that impairments in muscle strength in the lower extremities contribute to increased pain and joint space narrowing. Voluntary muscle contractions lead to various changes in muscle architecture, including changes in fascicle angle and pennation angle as well as muscle thickness. While muscle cross-sectional area and thickness are primarily associated with the magnitude of generated force, parameters such as pennation angle have been found to be more related to explosive force. Ultrasonography (US) is a non-invasive imaging method that can visualize these changes. Muscle architecture parameters obtained from US can provide reliable data related to muscle contractility independently of surrounding muscles. Furthermore, US is considered to have similar validity to MRI imaging, which is the gold standard for displaying muscle architecture. Additionally, isometric muscle strength can be reliably measured using handheld dynamometers. Although studies have investigated the relationship between muscle strength and muscle architecture determined by US in patients with knee OA, these studies have predominantly examined the relationship in the quadriceps muscle, and muscles associated with the ankle have not been studied extensively.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Numeric Rating Scale

    Time frame: 1 day

    Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.

  2. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 1 day

    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

  3. Isometric Knee Extension Muscle Strength

    Time frame: 1 day

    Isometric Knee Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

  4. Isometric Ankle Dorsiflexion Muscle Strength

    Time frame: 1 day

    Isometric Ankle Dorsiflexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

  5. Isometric Ankle Plantar Flexion Muscle Strength

    Time frame: 1 day

    Isometric Ankle Plantar Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

  6. Health Assessment Questionnaire (HAQ)

    Time frame: 1 day

    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.

  7. Outcome Measures in Rheumatology (OMERACT) ultrasound scores for knee osteoarthritis (OA)

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Evaluation of the Relationship Between the Architecture of the Quadriceps, Tibialis Anterior and Gastrocnemius Muscles and Muscle Strength in Female Gonarthrosis Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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