drugset / Trial / NCT05450458
Hyaluronic Acid in Overuse Knee Pain
NaSingle-groupOpen-labelTreatment
Summary
Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.
Timeline
- Start
- 2023-02-01
- Primary completion
- 2024-10-30
- Completion
- 2025-04-30
Publications
- Background Patel DR, Villalobos A. Evaluation and management of knee pain in young athletes: overuse injuries of the knee. Transl Pediatr. 2017 Jul;6(3):190-198. doi: 10.21037/tp.2017.04.05.
- Background Nicolini AP, de Carvalho RT, Matsuda MM, Sayum JF, Cohen M. Common injuries in athletes' knee: experience of a specialized center. Acta Ortop Bras. 2014;22(3):127-31. doi: 10.1590/1413-78522014220300475.
- Background Fuller CW, Ekstrand J, Junge A, Andersen TE, Bahr R, Dvorak J, Hagglund M, McCrory P, Meeuwisse WH. Consensus statement on injury definitions and data collection procedures in studies of football (soccer) injuries. Br J Sports Med. 2006 Mar;40(3):193-201. doi: 10.1136/bjsm.2005.025270.
- Background Majewski M, Susanne H, Klaus S. Epidemiology of athletic knee injuries: A 10-year study. Knee. 2006 Jun;13(3):184-8. doi: 10.1016/j.knee.2006.01.005. Epub 2006 Apr 17.
- Background Wilder RP, Sethi S. Overuse injuries: tendinopathies, stress fractures, compartment syndrome, and shin splints. Clin Sports Med. 2004 Jan;23(1):55-81, vi. doi: 10.1016/S0278-5919(03)00085-1.
- Background Aicale R, Tarantino D, Maffulli N. Overuse injuries in sport: a comprehensive overview. J Orthop Surg Res. 2018 Dec 5;13(1):309. doi: 10.1186/s13018-018-1017-5.
- Background Paoloni M, Bernetti A, Belelli A, Brignoli O, Buoso S, Caputi AP, Catani F, Coclite D, Fini M, Mantovani L, Migliore A, Napoletano A, Viora U, Santilli V. Appropriateness of clinical and organizational criteria for intra-articular injection therapies in osteoarthritis. A Delphi method consensus initiative among experts in Italy. Ann Ist Super Sanita. 2015;51(2):131-8. doi: 10.4415/ANN_15_02_11.
- Background Yang J, Tibbetts AS, Covassin T, Cheng G, Nayar S, Heiden E. Epidemiology of overuse and acute injuries among competitive collegiate athletes. J Athl Train. 2012 Mar-Apr;47(2):198-204. doi: 10.4085/1062-6050-47.2.198.
- Background Drawer S, Fuller CW. Propensity for osteoarthritis and lower limb joint pain in retired professional soccer players. Br J Sports Med. 2001 Dec;35(6):402-8. doi: 10.1136/bjsm.35.6.402.
- Background Vannini F, Spalding T, Andriolo L, Berruto M, Denti M, Espregueira-Mendes J, Menetrey J, Peretti GM, Seil R, Filardo G. Sport and early osteoarthritis: the role of sport in aetiology, progression and treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2016 Jun;24(6):1786-96. doi: 10.1007/s00167-016-4090-5. Epub 2016 Apr 4.
- Background Frohlich S, Pazeller S, Cherati AS, Muller E, Frey WO, Sporri J. Overuse injuries in the knee, back and hip of top elite female alpine skiers during the off-season preparation period: prevalence, severity and their association with traumatic preinjuries and training load. BMJ Open Sport Exerc Med. 2020 Dec 24;6(1):e000892. doi: 10.1136/bmjsem-2020-000892. eCollection 2020.
- Background Rincon GA, Vyas D, Zhou J, Fu FH, Oiestad BE, Holm I, Aune AK, Gunderson R, Myklebust G, Engebretsen L, Fosdahl M, Risberg MA. "Knee function and prevalence of knee osteoarthritis after anterior cruciate ligament reconstruction: a prospective study with 10 to 15 years of follow-up". Letter to the editor. Am J Sports Med. 2011 Apr;39(4):NP3; author reply NP3-4. doi: 10.1177/0363546511403704. No abstract available.
- Background KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
- Background Hunter DJ, Lo GH, Gale D, Grainger AJ, Guermazi A, Conaghan PG. The reliability of a new scoring system for knee osteoarthritis MRI and the validity of bone marrow lesion assessment: BLOKS (Boston Leeds Osteoarthritis Knee Score). Ann Rheum Dis. 2008 Feb;67(2):206-11. doi: 10.1136/ard.2006.066183. Epub 2007 May 1.
- Background Maffulli N, Regine R, Carrillo F, Minelli S, Beaconsfield T. Ultrasonographic scan in knee pain in athletes. Br J Sports Med. 1992 Jun;26(2):93-6. doi: 10.1136/bjsm.26.2.93.
- Background Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
- Background Luyten FP, Denti M, Filardo G, Kon E, Engebretsen L. Definition and classification of early osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. 2012 Mar;20(3):401-6. doi: 10.1007/s00167-011-1743-2. Epub 2011 Nov 8.
- Background Hoemann C, Kandel R, Roberts S, Saris DB, Creemers L, Mainil-Varlet P, Methot S, Hollander AP, Buschmann MD. International Cartilage Repair Society (ICRS) Recommended Guidelines for Histological Endpoints for Cartilage Repair Studies in Animal Models and Clinical Trials. Cartilage. 2011 Apr;2(2):153-72. doi: 10.1177/1947603510397535.
- Background Peterfy CG, Guermazi A, Zaim S, Tirman PF, Miaux Y, White D, Kothari M, Lu Y, Fye K, Zhao S, Genant HK. Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage. 2004 Mar;12(3):177-90. doi: 10.1016/j.joca.2003.11.003.
- Background Leslie M. Knee osteoarthritis management therapies. Pain Manag Nurs. 2000 Jun;1(2):51-7. doi: 10.1053/jpmn.2000.7782.
- Background Demange MK, Sisto M, Rodeo S. Future trends for unicompartmental arthritis of the knee: injectables & stem cells. Clin Sports Med. 2014 Jan;33(1):161-74. doi: 10.1016/j.csm.2013.06.006. Epub 2013 Jul 19.
- Background Sandmark H, Hogstedt C, Lewold S, Vingard E. Osteoarthrosis of the knee in men and women in association with overweight, smoking, and hormone therapy. Ann Rheum Dis. 1999 Mar;58(3):151-5. doi: 10.1136/ard.58.3.151.
- Background Fransen M, McConnell S. Land-based exercise for osteoarthritis of the knee: a metaanalysis of randomized controlled trials. J Rheumatol. 2009 Jun;36(6):1109-17. doi: 10.3899/jrheum.090058. Epub 2009 May 15.
- Background de Sire A, Agostini F, Lippi L, Mangone M, Marchese S, Cisari C, Bernetti A, Invernizzi M. Oxygen-Ozone Therapy in the Rehabilitation Field: State of the Art on Mechanisms of Action, Safety and Effectiveness in Patients with Musculoskeletal Disorders. Biomolecules. 2021 Feb 26;11(3):356. doi: 10.3390/biom11030356.
- Background Hiemstra LA, Kerslake S, Irving C. Anterior knee pain in the athlete. Clin Sports Med. 2014 Jul;33(3):437-59. doi: 10.1016/j.csm.2014.03.010. Epub 2014 May 24.
- Background Brophy RH, Fillingham YA. AAOS Clinical Practice Guideline Summary: Management of Osteoarthritis of the Knee (Nonarthroplasty), Third Edition. J Am Acad Orthop Surg. 2022 May 1;30(9):e721-e729. doi: 10.5435/JAAOS-D-21-01233.
- Background Trojian TH, Concoff AL, Joy SM, Hatzenbuehler JR, Saulsberry WJ, Coleman CI. AMSSM Scientific Statement Concerning Viscosupplementation Injections for Knee Osteoarthritis: Importance for Individual Patient Outcomes. Clin J Sport Med. 2016 Jan;26(1):1-11. doi: 10.1097/JSM.0000000000000274.
- Background Kalkhoven J, Coutts AJ, Impellizzeri FM. 'Training load error' is not a more accurate term than 'overuse' injury. Br J Sports Med. 2020 Aug;54(15):934-935. doi: 10.1136/bjsports-2019-101710. Epub 2020 Feb 24. No abstract available.
- Background Odole AC, Agbomeji OT, Onyeso OKK, Ojo JO, Odunaiya NA. Perspectives of Nigerian Athletes About Physiotherapy Services in Sports Injury Management: Implications for Rehabilitation. J Sport Rehabil. 2021 Feb 16;30(6):876-883. doi: 10.1123/jsr.2020-0292.
- Background Ammar TY, Pereira TA, Mistura SL, Kuhn A, Saggin JI, Lopes Junior OV. Viscosupplementation for treating knee osteoarthrosis: review of the literature. Rev Bras Ortop. 2015 Aug 5;50(5):489-94. doi: 10.1016/j.rboe.2015.07.007. eCollection 2015 Sep-Oct.
- Background Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
- Background Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.
- Background Kujala UM, Kaprio J, Sarna S. Osteoarthritis of weight bearing joints of lower limbs in former elite male athletes. BMJ. 1994 Jan 22;308(6923):231-4. doi: 10.1136/bmj.308.6923.231.
- Background Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hyaluronic Acid | Other / unclassified | 40 mg | Other |
Indications
No indication recorded.