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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06003413
Other study ID # 2020/162
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 24, 2023
Est. completion date October 1, 2023

Study information

Verified date August 2023
Source Bezmialem Vakif University
Contact Ozan Volkan Yurdakul, Assoc. Prof.
Phone +902124530453
Email yurdakul_ozan@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 1, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Dtsch Arztebl Int. 2010 Apr;107(16):294. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Rating Scale Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome. 1 day
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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