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

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003413
Collaborator
(none)
30
1
26
35.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of the Relationship Between the Architecture of the Quadriceps, Tibialis Anterior and Gastrocnemius Muscles and Muscle Strength in Female Gonarthrosis Patients
    Anticipated Study Start Date :
    Sep 5, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Osteoarthritic Knee

    Knees with Kellgren-Lawrence Stage 2-4 will admitted to this group Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length. Outcome Measures in Rheumatology (OMERACT) Ultrasound scores for knee will be evaluated Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer

    Healthy Knee

    Healthy knees will be admitted to this group Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length. Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer

    Outcome Measures

    Primary Outcome Measures

    1. Numeric Rating Scale [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) [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 [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 [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 [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) [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) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bezmialem Vakif University Istanbul Fatih Turkey 34093

    Sponsors and Collaborators

    • Bezmialem Vakif University

    Investigators

    • Study Director: Ozan Volkan Yurdakul, Assoc. Prof., Bezmialem Vakif University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bezmialem Vakif University
    ClinicalTrials.gov Identifier:
    NCT06003413
    Other Study ID Numbers:
    • 2020/162
    First Posted:
    Aug 22, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2023