Effect of subacromial sodium hyaluronate injection on rotator cuff disease: A double-blind placebo-controlled clinical trial

Authors
Alireza Moghtaderi 1
Sepideh Sajadiyeh 1
Saeid Khosrawi 1
Farnaz Dehghan 1
Vahid Bateni 2
1 Department of Physical Medicine and Rehabilitation, Medical University of Isfahan, Isfahan, Iran
2 Department of Radiology, Medical University of Isfahan, Isfahan, Iran
Abstract
Background: Rotator cuff disease is a common cause of shoulder pain. There are studies about the effectiveness of sodium hyaluronate injection on shoulder and knee pain, but few studies demonstrating the efficacy of sodium hyaluronate ultrasonography guided injection for rotator cuff disease. This study evaluates effectiveness of ultrasonography guided subacromial sodium hyaluronate injection in patients with impingment syndrome without rotator cuff complete tear.
Materials and Methods: This prospective, double-blind, placebo controlled clinical trial study was performed among 40 patients with subacromial impingement syndrome without complete tear of rotator cuff. Patients randomly injected ultrasonography guided in 2 groups: Case group by 20 mg of sodium hyaluronate (Fermathron™) and control group by 0.9% normal saline. Both groups received 3 weekly injections. The pain score (100 mm visual analogue score [VAS]) was evaluated before first injection and one week after each injection. The constant score was evaluated before first and 12 week after last injection. Data was analyzed statistically by Independent t-test.
Results: In both groups mean VAS has decreased, but more significantly in case group (P < 0.001). Mean constant score was significantly higher in case group 12 weeks after last injection (P < 0.001). The constant score improved 12 weeks after the last injection in both groups with a significantly better result in case group (P < 0.001).
Conclusion: Subacromial injections of sodium hyaluronate are effective in treating rotator cuff disease without complete tears.

Keywords

1. Praemer AF, Rice D. Musculoskeletal conditions in the United States. Rosemont, IL. American Academy of Orthopaedic Surgeons; 1999;2:27-33.  Back to cited text no. 1
    
2. Lin JC, Weintraub N, Aragaki DR. Nonsurgical treatment for rotator cuff injury in the elderly. J Am Med Dir Assoc 2008;9:626-32.  Back to cited text no. 2
[PUBMED]    
3. Andrews JR. Diagnosis and treatment of chronic painful shoulder: Review of nonsurgical interventions. Arthroscopy 2005;21:333-47.  Back to cited text no. 3
[PUBMED]    
4. Frontera WR, Silver JK, Rizzo TD. Rotator cuff tendinitis. Essentials of Physical Medicine and Rehabilitation. 2 nd ed. Philadelphia: Saunders; 2008. p. 75.  Back to cited text no. 4
    
5. Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, et al. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: Experimental study of periarticular injections. Eur J Radiol 2008;68:170-3.  Back to cited text no. 5
    
6. Braddom RL. Peripheral joint and soft tissue injection techniques. Physical Medicine and Rehabilitation. 4 th ed. Philadelphia: Saunders; 2011. p. 520.  Back to cited text no. 6
    
7. Costantino C, Olvirri S. Rehabilitative and infiltrative treatment with hyaluronic acid in elderly patients with rotator cuff tears. Acta Biomed 2009;80:225-9.  Back to cited text no. 7
    
8. Blaine T, Moskowitz R, Udell J, Skyhar M, Levin R, Friedlander J, et al. Treatment of persistent shoulder pain with sodium hyaluronate: A randomized, controlled trial. A multicenter study. J Bone Joint Surg Am 2008;90:970-9.  Back to cited text no. 8
    
9. Silverstein E, Leger R, Shea KP. The use of intra-articular hylan G-F 20 in the treatment of symptomatic osteoarthritis of the shoulder: A preliminary study. Am J Sports Med 2007;35:979-85.  Back to cited text no. 9
    
10. Wu JJ, Shih LY, Hsu HC, Chen TH. The double-blind test of sodium hyaluronate (ARTZ) on osteoarthritis knee. Zhonghua Yi Xue Za Zhi (Taipei) 1997;59:99-106.  Back to cited text no. 10
    
11. Dahl LB, Dahl IM, Engström-Laurent A, Granath K. Concentration and molecular weight of sodium hyaluronate in synovial fluid from patients with rheumatoid arthritis and other arthropathies. Ann Rheum Dis 1985;44:817-22.  Back to cited text no. 11
    
12. Itokazu M, Matsunaga T. Clinical evaluation of high-molecular-weight sodium hyaluronate for the treatment of patients with periarthritis of the shoulder. Clin Ther 1995;17:946-55.  Back to cited text no. 12
    
13. Takagishi N, Minamikawa H, Iwamoto H, Kida H, Okuyama S, Tanaka M, et al. Clinical evaluation of SPH (high molecular weight sodium hyaluronate) on periarthritis of the shoulder. Jpn J Pharmacol Ther 1998;16:3553-67.  Back to cited text no. 13
    
14. Yamamoto R, Namiki O, Iwata H, Shinmei M, Mikasa M, Ogawa N. Randomized cooperative study of sodium hyaluronate (SPH) on perarthritis scapulohumeralis. Jpn J Pharmacol Ther 1988;19:713-33.  Back to cited text no. 14
    
15. Shibata Y, Midorikawa K, Emoto G, Naito M. Clinical evaluation of sodium hyaluronate for the treatment of patients with rotator cuff tear. J Shoulder Elbow Surg 2001;10:209-16.  Back to cited text no. 15
    
16. Adler RS, Sofka CM. Percutaneous ultrasound-guided injections in the musculoskeletal system. Ultrasound Q 2003;19:3-12.  Back to cited text no. 16
    
17. Kluger R, Mayrhofer R, Kröner A, Pabinger C, Pärtan G, Hruby W, et al. Sonographic versus magnetic resonance arthrographic evaluation of full-thickness rotator cuff tears in millimeters. J Shoulder Elbow Surg 2003;12:110-6.  Back to cited text no. 17
    
18. Kim HA, Kim SH, Seo YI. Ultrasonographic findings of painful shoulders and correlation between physical examination and ultrasonographic rotator cuff tear. Mod Rheumatol 2007;17:213-9.  Back to cited text no. 18
    
19. Teefey SA, Petersen B, Prather H. Shoulder Ultrasound vs MRI for rotator cuff pathology. PM R 2009;1:490-5.  Back to cited text no. 19
    
20. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;214:160-4.  Back to cited text no. 20
    
21. Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev 2006;19:CD005321.  Back to cited text no. 21
    
22. Lo GH, LaValley M, McAlindon T, Felson DT. Intra-articular hyaluronic acid in treatment of knee osteoarthritis: A meta-analysis. JAMA 2003;290:3115-21.  Back to cited text no. 22
    
23. Moreland LW. Intra-articular hyaluronan (hyaluronic acid) and hylans for the treatment of osteoarthritis: Mechanisms of action. Arthritis Res Ther 2003;5:54-67.  Back to cited text no. 23
    
24. Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, et al. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: A randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg 2010;19:557-63.  Back to cited text no. 24
    
25. Kim YS, Park JY, Lee CS, Lee SJ. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg 2012;21:722-7.  Back to cited text no. 25
    
26. Ghosh P. The role of hyaluronic acid (hyaluronan) in health and disease: Interactions with cells, cartilage and components of synovial fluid. Clin Exp Rheumatol 1994;12:75-82.  Back to cited text no. 26
    
27. Rosier RN, O'Keefe RJ. Hyaluronic acid therapy. Instr Course Lect 2000;49:495-502.  Back to cited text no. 27
    
28. Ko JY, Huang CC, Chen WJ, Chen CE, Chen SH, Wang CJ. Pathogenesis of partial tear of the rotator cuff: A clinical and pathologic study. J Shoulder Elbow Surg 2006;15:271-8.  Back to cited text no. 28
    
Advanced Biomedical Research
Volume 2013, November
November 2013
Pages 1-5