Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies

Summary

The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections. The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2). The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality. Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used: Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement. Shoulder Disability Questionnaire (SDQ) for functionality. Assessments will be conducted at the following time points: T0) Before the administration of corticosteroid intra-articular injection (baseline). T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0). T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1). T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0).

Timeline

Start

2024-08-10

Primary completion

2025-11-01

Completion

2025-12-31

Publications

• Background Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
• Background Greving K, Dorrestijn O, Winters JC, Groenhof F, van der Meer K, Stevens M, Diercks RL. Incidence, prevalence, and consultation rates of shoulder complaints in general practice. Scand J Rheumatol. 2012 Mar;41(2):150-5. doi: 10.3109/03009742.2011.605390. Epub 2011 Sep 21.
• Background Dabija DI, Gao C, Edwards TL, Kuhn JE, Jain NB. Genetic and familial predisposition to rotator cuff disease: a systematic review. J Shoulder Elbow Surg. 2017 Jun;26(6):1103-1112. doi: 10.1016/j.jse.2016.11.038. Epub 2017 Feb 2.
• Background Herrmann SJ, Izadpanah K, Sudkamp NP, Strohm PC. Tears of the rotator cuff. Causes--diagnosis--treatment. Acta Chir Orthop Traumatol Cech. 2014;81(4):256-66.
• Background Via AG, De Cupis M, Spoliti M, Oliva F. Clinical and biological aspects of rotator cuff tears. Muscles Ligaments Tendons J. 2013 Jul 9;3(2):70-9. doi: 10.11138/mltj/2013.3.2.070. Print 2013 Apr.
• Background Ackermann PW, Renstrom P. Tendinopathy in sport. Sports Health. 2012 May;4(3):193-201. doi: 10.1177/1941738112440957.
• Background Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.
• Background van der Worp H, van den Akker-Scheek I, van Schie H, Zwerver J. ESWT for tendinopathy: technology and clinical implications. Knee Surg Sports Traumatol Arthrosc. 2013 Jun;21(6):1451-8. doi: 10.1007/s00167-012-2009-3. Epub 2012 May 1.
• Background Osti L, Buda M, Buono AD, Osti R, Massari L. Clinical evidence in the treatment of rotator cuff tears with hyaluronic acid. Muscles Ligaments Tendons J. 2016 Feb 13;5(4):270-5. doi: 10.11138/mltj/2015.5.4.270. eCollection 2015 Oct-Dec.
• Background Lee LC, Lieu FK, Lee HL, Tung TH. Effectiveness of hyaluronic acid administration in treating adhesive capsulitis of the shoulder: a systematic review of randomized controlled trials. Biomed Res Int. 2015;2015:314120. doi: 10.1155/2015/314120. Epub 2015 Jan 31.
• Background Salamanna F, Frizziero A, Pagani S, Giavaresi G, Curzi D, Falcieri E, Marini M, Abruzzo PM, Martini L, Fini M. Metabolic and cytoprotective effects of in vivo peri-patellar hyaluronic acid injections in cultured tenocytes. Connect Tissue Res. 2015 Feb;56(1):35-43. doi: 10.3109/03008207.2014.979166. Epub 2014 Nov 13.
• Background Iwata H. Pharmacologic and clinical aspects of intraarticular injection of hyaluronate. Clin Orthop Relat Res. 1993 Apr;(289):285-91.
• Background Oliva F, Marsilio E, Asparago G, Frizziero A, Berardi AC, Maffulli N. The Impact of Hyaluronic Acid on Tendon Physiology and Its Clinical Application in Tendinopathies. Cells. 2021 Nov 9;10(11):3081. doi: 10.3390/cells10113081.
• Background Abate M, Schiavone C, Salini V. The use of hyaluronic acid after tendon surgery and in tendinopathies. Biomed Res Int. 2014;2014:783632. doi: 10.1155/2014/783632. Epub 2014 May 8.
• Background Franchi M, Trire A, Quaranta M, Orsini E, Ottani V. Collagen structure of tendon relates to function. ScientificWorldJournal. 2007 Mar 30;7:404-20. doi: 10.1100/tsw.2007.92.
• Background Hijlkema A, Roozenboom C, Mensink M, Zwerver J. The impact of nutrition on tendon health and tendinopathy: a systematic review. J Int Soc Sports Nutr. 2022 Aug 3;19(1):474-504. doi: 10.1080/15502783.2022.2104130. eCollection 2022.
• Background Boldt KS, Olson BL, Thiele RM. Effects of Collagen and Exercise on Tendon Properties and Pain: A Critically Appraised Topic. J Sport Rehabil. 2023 Sep 27;32(8):938-941. doi: 10.1123/jsr.2023-0115. Print 2023 Nov 1.
• Background Campos LD, Santos Junior VA, Pimentel JD, Carrega GLF, Cazarin CBB. Collagen supplementation in skin and orthopedic diseases: A review of the literature. Heliyon. 2023 Mar 28;9(4):e14961. doi: 10.1016/j.heliyon.2023.e14961. eCollection 2023 Apr.
• Background Kalman DS, Heimer M, Valdeon A, Schwartz H, Sheldon E. Effect of a natural extract of chicken combs with a high content of hyaluronic acid (Hyal-Joint) on pain relief and quality of life in subjects with knee osteoarthritis: a pilot randomized double-blind placebo-controlled trial. Nutr J. 2008 Jan 21;7:3. doi: 10.1186/1475-2891-7-3.
• Background Lopez-Vidriero E, Olive-Vilas R, Lopez-Capape D, Varela-Sende L, Lopez-Vidriero R, Til-Perez L. Efficacy and Tolerability of Progen, a Nutritional Supplement Based on Innovative Plasma Proteins, in ACL Reconstruction: A Multicenter Randomized Controlled Trial. Orthop J Sports Med. 2019 Feb 27;7(2):2325967119827237. doi: 10.1177/2325967119827237. eCollection 2019 Feb.
• Background Leon-Lopez A, Morales-Penaloza A, Martinez-Juarez VM, Vargas-Torres A, Zeugolis DI, Aguirre-Alvarez G. Hydrolyzed Collagen-Sources and Applications. Molecules. 2019 Nov 7;24(22):4031. doi: 10.3390/molecules24224031.
• Background Clark KL, Sebastianelli W, Flechsenhar KR, Aukermann DF, Meza F, Millard RL, Deitch JR, Sherbondy PS, Albert A. 24-Week study on the use of collagen hydrolysate as a dietary supplement in athletes with activity-related joint pain. Curr Med Res Opin. 2008 May;24(5):1485-96. doi: 10.1185/030079908x291967. Epub 2008 Apr 15.
• Background Noriega-Gonzalez DC, Drobnic F, Caballero-Garcia A, Roche E, Perez-Valdecantos D, Cordova A. Effect of Vitamin C on Tendinopathy Recovery: A Scoping Review. Nutrients. 2022 Jun 27;14(13):2663. doi: 10.3390/nu14132663.
• Background Ozgen M, Firat S, Sarsan A, Topuz O, Ardic F, Baydemir C. Short- and long-term results of clinical effectiveness of sodium hyaluronate injection in supraspinatus tendinitis. Rheumatol Int. 2012 Jan;32(1):137-44. doi: 10.1007/s00296-010-1577-0. Epub 2010 Jul 31.
• Background Croft P, Pope D, Zonca M, O'Neill T, Silman A. Measurement of shoulder related disability: results of a validation study. Ann Rheum Dis. 1994 Aug;53(8):525-8. doi: 10.1136/ard.53.8.525.
• Background Brindisino F, Pellicciari L, Lorusso M, Pennella D, Padua R, Di Bari M. Cross-cultural adaptation, reliability, and validity of the Italian version of the Shoulder Disability Questionnaire. Musculoskelet Sci Pract. 2020 Apr;46:102123. doi: 10.1016/j.msksp.2020.102123. Epub 2020 Jan 31.
• Background Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.
• Background Moghtaderi A, Sajadiyeh S, Khosrawi S, Dehghan F, Bateni V. Effect of subacromial sodium hyaluronate injection on rotator cuff disease: A double-blind placebo-controlled clinical trial. Adv Biomed Res. 2013 Nov 30;2:89. doi: 10.4103/2277-9175.122517. eCollection 2013.
• Background Byun SD, Park DH, Choi WD, Lee ZI. Subacromial Bursa Injection of Hyaluronate with Steroid in Patients with Peri-articular Shoulder Disorders. Ann Rehabil Med. 2011 Oct;35(5):664-72. doi: 10.5535/arm.2011.35.5.664. Epub 2011 Oct 31.

Drugs

Indications