Osteoarthritis Clinical Trial
Official title:
Evaluation of the Relationship Between the Architecture of the Quadriceps, Tibialis Anterior and Gastrocnemius Muscles and Muscle Strength in Female Gonarthrosis Patients
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
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 all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A | |
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A |