NCT06003413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 24, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 15, 2023

Last Update Submit

August 6, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Numeric Rating Scale

    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)

    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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (14)

  • Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.

    PMID: 20305774BACKGROUND
  • Varbakken K, Loras H, Nilsson KG, Engdal M, Stensdotter AK. Relative difference in muscle strength between patients with knee osteoarthritis and healthy controls when tested bilaterally and joint-inclusive: an exploratory cross-sectional study. BMC Musculoskelet Disord. 2019 Dec 9;20(1):593. doi: 10.1186/s12891-019-2957-6.

    PMID: 31818286BACKGROUND
  • Glass NA, Torner JC, Frey Law LA, Wang K, Yang T, Nevitt MC, Felson DT, Lewis CE, Segal NA. The relationship between quadriceps muscle weakness and worsening of knee pain in the MOST cohort: a 5-year longitudinal study. Osteoarthritis Cartilage. 2013 Sep;21(9):1154-9. doi: 10.1016/j.joca.2013.05.016.

    PMID: 23973125BACKGROUND
  • Fukunaga T, Ichinose Y, Ito M, Kawakami Y, Fukashiro S. Determination of fascicle length and pennation in a contracting human muscle in vivo. J Appl Physiol (1985). 1997 Jan;82(1):354-8. doi: 10.1152/jappl.1997.82.1.354.

    PMID: 9029238BACKGROUND
  • Hodges PW, Pengel LH, Herbert RD, Gandevia SC. Measurement of muscle contraction with ultrasound imaging. Muscle Nerve. 2003 Jun;27(6):682-92. doi: 10.1002/mus.10375.

    PMID: 12766979BACKGROUND
  • Bazyler CD, Mizuguchi S, Harrison AP, Sato K, Kavanaugh AA, DeWeese BH, Stone MH. Changes in Muscle Architecture, Explosive Ability, and Track and Field Throwing Performance Throughout a Competitive Season and After a Taper. J Strength Cond Res. 2017 Oct;31(10):2785-2793. doi: 10.1519/JSC.0000000000001619.

    PMID: 27575250BACKGROUND
  • Gerstner GR, Thompson BJ, Rosenberg JG, Sobolewski EJ, Scharville MJ, Ryan ED. Neural and Muscular Contributions to the Age-Related Reductions in Rapid Strength. Med Sci Sports Exerc. 2017 Jul;49(7):1331-1339. doi: 10.1249/MSS.0000000000001231.

    PMID: 28166121BACKGROUND
  • Zaras ND, Stasinaki AN, Methenitis SK, Krase AA, Karampatsos GP, Georgiadis GV, Spengos KM, Terzis GD. Rate of Force Development, Muscle Architecture, and Performance in Young Competitive Track and Field Throwers. J Strength Cond Res. 2016 Jan;30(1):81-92. doi: 10.1519/JSC.0000000000001048.

    PMID: 26049793BACKGROUND
  • Zhang Q, Sheng Z, Moore-Clingenpeel F, Kim K, Sharma N. Ankle Dorsiflexion Strength Monitoring by Combining Sonomyography and Electromyography. IEEE Int Conf Rehabil Robot. 2019 Jun;2019:240-245. doi: 10.1109/ICORR.2019.8779530.

    PMID: 31374636BACKGROUND
  • Walton JM, Roberts N, Whitehouse GH. Measurement of the quadriceps femoris muscle using magnetic resonance and ultrasound imaging. Br J Sports Med. 1997 Mar;31(1):59-64. doi: 10.1136/bjsm.31.1.59.

    PMID: 9132215BACKGROUND
  • Wang CY, Olson SL, Protas EJ. Test-retest strength reliability: hand-held dynamometry in community-dwelling elderly fallers. Arch Phys Med Rehabil. 2002 Jun;83(6):811-5. doi: 10.1053/apmr.2002.32743.

    PMID: 12048660BACKGROUND
  • Malas FU, Ozcakar L, Kaymak B, Ulasli A, Guner S, Kara M, Akinci A. Effects of different strength training on muscle architecture: clinical and ultrasonographic evaluation in knee osteoarthritis. PM R. 2013 Aug;5(8):655-62. doi: 10.1016/j.pmrj.2013.03.005. Epub 2013 Mar 7.

    PMID: 23474211BACKGROUND
  • Blazevich AJ, Cannavan D, Coleman DR, Horne S. Influence of concentric and eccentric resistance training on architectural adaptation in human quadriceps muscles. J Appl Physiol (1985). 2007 Nov;103(5):1565-75. doi: 10.1152/japplphysiol.00578.2007. Epub 2007 Aug 23.

    PMID: 17717119BACKGROUND
  • Taniguchi M, Fukumoto Y, Kobayashi M, Kawasaki T, Maegawa S, Ibuki S, Ichihashi N. Quantity and Quality of the Lower Extremity Muscles in Women with Knee Osteoarthritis. Ultrasound Med Biol. 2015 Oct;41(10):2567-74. doi: 10.1016/j.ultrasmedbio.2015.05.014. Epub 2015 Jun 20.

    PMID: 26099784BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ozan Volkan Yurdakul, Assoc. Prof.

    Bezmialem Vakif University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

August 24, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations