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

August 6, 2024 updated by: Bezmialem Vakif University

Evaluation of the Relationship Between the Architecture of the Quadriceps, Tibialis Anterior and Gastrocnemius Muscles 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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who applied to the Bezmialem Vakıf University, Physical Medicine and Rehabilitation Outpatient Clinic appropriate for eligibility criteria will be enrolled

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
Numeric Rating Scale
Time Frame: 1 day
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
1 day
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
1 day
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
1 day
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2023

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

March 30, 2024

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2020/162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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