Overuse Injury Clinical Trial
Official title:
Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 55 Years |
Eligibility | Inclusion Criteria: - - Patients with knee pain for more than 3 months - Patients between 30 and 55 years old - Patients without a history of previous knee joint surgery. - Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases. - Patients who perform impact social sports at least 3 times a week for more than 1 hour in the last 3 months prior to treatment. - Patients without a history of allergies to non-steroidal anti-inflammatory drugs. - Patients with no history of infection in or around the knee. Exclusion Criteria: - - Patients who cannot be categorized as social athletes. - Patients with an associated sports injury that limits their sports practice. - Patients who have a treatment associated with knee pain independent of that established in the study protocol. |
Country | Name | City | State |
---|---|---|---|
Mexico | Issemym Tlalnepantla | Tlanepantla |
Lead Sponsor | Collaborator |
---|---|
Hospital Regional Tlalnepantla |
Mexico,
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. Review. — View Citation
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. — View Citation
Ammar TY, Pereira TA, Mistura SL, Kuhn A, Saggin JI, Lopes Júnior 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. Review. — View Citation
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. — View Citation
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). pii: 356. doi: 10.3390/biom11030356. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. — View Citation
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. — View Citation
Fröhlich S, Pazeller S, Cherati AS, Müller E, Frey WO, Spörri 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. — View Citation
Fuller CW, Ekstrand J, Junge A, Andersen TE, Bahr R, Dvorak J, Hägglund 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. Review. — View Citation
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. Review. — View Citation
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. Epub 2007 Aug 6. — View Citation
Hoemann C, Kandel R, Roberts S, Saris DB, Creemers L, Mainil-Varlet P, Méthot 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. — View Citation
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. Epub 2007 May 1. Review. — View Citation
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. — View Citation
KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. — View Citation
Kujala UM, Kaprio J, Sarna S. Osteoarthritis of weight bearing joints of lower limbs in former élite male athletes. BMJ. 1994 Jan 22;308(6923):231-4. Erratum in: BMJ 1994 Mar 26;308(6932):819. — View Citation
Leslie M. Knee osteoarthritis management therapies. Pain Manag Nurs. 2000 Jun;1(2):51-7. Review. — View Citation
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. — View Citation
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. — View Citation
Majewski M, Susanne H, Klaus S. Epidemiology of athletic knee injuries: A 10-year study. Knee. 2006 Jun;13(3):184-8. Epub 2006 Apr 17. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Sandmark H, Hogstedt C, Lewold S, Vingård 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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Wilder RP, Sethi S. Overuse injuries: tendinopathies, stress fractures, compartment syndrome, and shin splints. Clin Sports Med. 2004 Jan;23(1):55-81, vi. Review. — View Citation
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. — View Citation
* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the knee injury and osteoarthritis outcome score | To demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen decrease the pain during spots and day-living activities by measured the improvement of knee symptoms through the KOOS score:
- The Knee injury and Osteoarthritis Outcome Score: Evaluate Symptoms + Stiffness subtotal, Pain, Function, daily living, sports and recreational activities and quality of life. Each variable has a percentage score from 0 to 100%, at the end the results are averaged, obtaining a final percentage where 100% means the greatest pain and knee discomfort and 0% means the knee is healthy and without discomfort. |
6 Months | |
Primary | Efficacy of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome assessed with the International Knee Documentation Committee score | Demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen improves the perception of functionality in the knee of athletes through the IKDC questionaire
- The International Knee Documentation Committee: Contains sections on knee symptoms, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). 0 is the lowest score and 87 is the highest corresponding to 100%. |
6 Months | |
Secondary | Safety of Hyaluronic acid with sorbitol (SYNOLIS VA ®) in overuse knee syndrome by the number of adverse effects in participants. | Evaluate the SYNOLIS VA ® safety after two doses of intra articular injection by tracking the number of patient withdrawals and their adverse events including: skin irritation, knee redness, local pain for more than 24 hours, edema for more than 48 hours and itching at the application site. | 6 months |
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