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临床试验/NCT06003413
NCT06003413已完成不适用

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

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Numeric Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Numeric Rating Scale

时间窗: 1 day

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

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

时间窗: 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

Health Assessment Questionnaire (HAQ)

时间窗: 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.

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

时间窗: 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

Isometric Ankle Dorsiflexion Muscle Strength

时间窗: 1 day

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

Isometric Ankle Plantar Flexion Muscle Strength

时间窗: 1 day

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

Isometric Knee Extension Muscle Strength

时间窗: 1 day

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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