A randomized, double-blind sham-controlled trial on the efficacy of arthroscopic tennis elbow release for the management of chronic lateral epicondylitis

Bogdan A Matache, Randa Berdusco, Franco Momoli, Peter L C Lapner, J W Pollock, Bogdan A Matache, Randa Berdusco, Franco Momoli, Peter L C Lapner, J W Pollock

Abstract

Background: Tennis elbow is a common elbow pathology typically affecting middle-aged individuals that can lead to significant disability. Most cases resolve within 2 years of symptom onset, but a subset of patients will develop persistent symptoms despite appropriate conservative management. There are several surgical approaches used to treat chronic tennis elbow, with arthroscopic surgery becoming an increasingly popular approach to address this pathology in North America. This procedure involves the arthroscopic release of the extensor carpi radialis brevis tendon (ECRB) origin at the elbow. The potential benefit of arthroscopic treatment of this condition is improved patient outcomes and shorter recovery time following surgery. The results of this technique have been reported only in the context of case series, which have shown positive results. However, in order to justify its widespread use and growing popularity, a high level of evidence study is required. The purpose of this prospective, randomized sham-controlled trial is to determine whether arthroscopic tennis elbow release is effective at treating chronic lateral epicondylitis.

Methods: We will conduct a prospective single center, double-blind, randomized sham-controlled parallel arm trial evaluating the efficacy of arthroscopic tennis elbow release in adult patients with symptoms for at least 6 months. Patients will undergo intraoperative randomization after diagnostic arthroscopy of the elbow to receive either ECRB release (through the creation of a lateral portal) or a sham lateral portal and no ECRB release. The primary outcome will be the Mayo Elbow Performance Score (MEPS) at 1 year follow-up. Secondary outcomes will be the abbreviated Disability of the Shoulder and Hand (DASH) score, American Shoulder and Elbow Surgeons elbow (ASES-e) score and grip strength at 3, 6, 12 and 24 months as well as return-to-work time, ability to return to full duty and adverse outcomes.

Discussion: Results of this study will provide empirical high quality evidence to guide clinical decision-making in patients with chronic tennis elbow.

Trial registration: NCT02236689 (September 8, 2014).

Keywords: Arthroscopic tennis elbow release; Lateral epicondylitis; Randomized controlled trial; Tennis elbow.

Figures

Fig. 1
Fig. 1
Study flowchart. Legend: two parallel randomization arms; ATER (blue) and sham procedure (green)

References

    1. Chard MD, Hazleman BL. Tennis elbow--a reappraisal. Br J Rheumatol. 1989;28(3):186–90. doi: 10.1093/rheumatology/28.3.186.
    1. Hamilton PG. The prevalence of humeral epicondylitis: a survey in general practice. J R Coll Gen Pract. 1986;36(291):464–5.
    1. Kivi P. The etiology and conservative treatment of humeral epicondylitis. Scand J Rehabil Med. 1983;15(1):37–41.
    1. Nirschl RP, Ashman ES. Elbow tendinopathy: tennis elbow. Clin Sports Med. 2003;22(4):813–36. doi: 10.1016/S0278-5919(03)00051-6.
    1. Taylor SA. Evaluation and Management of Elbow Tendinopathy. Sports Health. 2012;4(5):384–93. doi: 10.1177/1941738112454651.
    1. Cyriax JH. The pathology and treatment of tennis elbow1936 1936-10-01 00:00:00. 921-40 p.
    1. Murtagh JE. Tennis elbow. Aust Fam Physician. 1988;17(2):90–1.
    1. Hudak PL, Cole DC, Haines AT. Understanding prognosis to improve rehabilitation: the example of lateral elbow pain. Arch Phys Med Rehabil. 1996;77(6):586–93. doi: 10.1016/S0003-9993(96)90300-7.
    1. Bowen RE, Dorey FJ, Shapiro MS. Efficacy of nonoperative treatment for lateral epicondylitis. Am J Orthop (Belle Mead, NJ) 2001;30(8):642–6.
    1. Boyer MI, Hastings H. 2nd. Lateral tennis elbow: “Is there any science out there?”. J Shoulder Elb Surg. 1999;8(5):481–91. doi: 10.1016/S1058-2746(99)90081-2.
    1. Smidt N, van der Windt DA, Assendelft WJ, Deville WL, Korthals-de Bos IB, Bouter LM. Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial. Lancet. 2002;359(9307):657–62. doi: 10.1016/S0140-6736(02)07811-X.
    1. Bot SD, van der Waal JM, Terwee CB, van der Windt DA, Bouter LM, Dekker J. Course and prognosis of elbow complaints: a cohort study in general practice. Ann Rheum Dis. 2005;64(9):1331–6. doi: 10.1136/ard.2004.030320.
    1. Froimson AI. Treatment of tennis elbow with forearm support band. J Bone Joint Surg Am. 1971;53(1):183–4.
    1. Barrington J, Hage WD. Lateral epicondylitis (tennis elbow): nonoperative, open, or arthroscopic treatment? Curr Opin Orthop. 2003;14(4):291–5. doi: 10.1097/00001433-200308000-00013.
    1. Kalainov DM, Makowiec RL, Cohen MS. Arthroscopic tennis elbow release. Tech Hand Up Extrem Surg. 2007;11(1):2–7. doi: 10.1097/01.bth.0000248358.06825.98.
    1. Kraushaar BS, Nirschl RP. Tendinosis of the elbow (tennis elbow). Clinical features and findings of histological, immunohistochemical, and electron microscopy studies. J Bone Joint Surg Am. 1999;81(2):259–78. doi: 10.1302/0301-620X.81B2.9154.
    1. Baker CL, Jr, Murphy KP, Gottlob CA, Curd DT. Arthroscopic classification and treatment of lateral epicondylitis: two-year clinical results. J Shoulder Elb Surg. 2000;9(6):475–82. doi: 10.1067/mse.2000.108533.
    1. Ogilvie-Harris DJ, Schemitsch E. Arthroscopy of the elbow for removal of loose bodies. Arthroscopy. 1993;9(1):5–8. doi: 10.1016/S0749-8063(05)80335-4.
    1. Owens BD, Murphy KP, Kuklo TR. Arthroscopic release for lateral epicondylitis. Arthroscopy. 2001;17(6):582–7. doi: 10.1053/jars.2001.20098.
    1. Ruch DS, Papadonikolakis A, Campolattaro RM. The posterolateral plica: a cause of refractory lateral elbow pain. J Shoulder Elb Surg. 2006;15(3):367–70. doi: 10.1016/j.jse.2005.08.013.
    1. Lattermann C, Romeo AA, Anbari A, Meininger AK, McCarty LP, Cole BJ, et al. Arthroscopic debridement of the extensor carpi radialis brevis for recalcitrant lateral epicondylitis. J Shoulder Elb Surg. 2010;19(5):651–6. doi: 10.1016/j.jse.2010.02.008.
    1. Baker CL, Jr, Baker CL., 3rd Long-term follow-up of arthroscopic treatment of lateral epicondylitis. Am J Sports Med. 2008;36(2):254–60. doi: 10.1177/0363546507311599.
    1. Othman AM. Arthroscopic versus percutaneous release of common extensor origin for treatment of chronic tennis elbow. Arch Orthop Trauma Surg. 2011;131(3):383–8. doi: 10.1007/s00402-011-1260-2.
    1. Solheim E, Hegna J, Oyen J. Arthroscopic versus open tennis elbow release: 3- to 6-year results of a case-control series of 305 elbows. Arthroscopy. 2013;29(5):854–9. doi: 10.1016/j.arthro.2012.12.012.
    1. Yeoh KM, King GJ, Faber KJ, Glazebrook MA, Athwal GS. Evidence-based indications for elbow arthroscopy. Arthroscopy. 2012;28(2):272–82. doi: 10.1016/j.arthro.2011.10.007.
    1. Buchbinder R, Johnston RV, Barnsley L, Assendelft WJ, Bell SN, Smidt N. Surgery for lateral elbow pain. Cochrane Database Syst Rev. 2011;16(3):Cd003525.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ (Clinical research ed) 2010;340:c332. doi: 10.1136/bmj.c332.
    1. Cusick MC, Bonnaig NS, Azar FM, Mauck BM, Smith RA, Throckmorton TW. Accuracy and reliability of the Mayo Elbow Performance Score. J Hand Surg. 2014;39(6):1146–50. doi: 10.1016/j.jhsa.2014.01.041.
    1. Longo UG, Franceschi F, Loppini M, Maffulli N, Denaro V. Rating systems for evaluation of the elbow. Br Med Bull. 2008;87:131–61. doi: 10.1093/bmb/ldn023.
    1. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG) Am J Ind Med. 1996;29(6):602–8. doi: 10.1002/(SICI)1097-0274(199606)29:6<602::AID-AJIM4>;2-L.
    1. de Boer YA, Hazes JM, Winia PC, Brand R, Rozing PM. Comparative responsiveness of four elbow scoring instruments in patients with rheumatoid arthritis. J Rheumatol. 2001;28(12):2616–23.
    1. Raeissadat SA, Sedighipour L, Rayegani SM, Bahrami MH, Bayat M, Rahimi R. Effect of Platelet-Rich Plasma (PRP) versus Autologous Whole Blood on Pain and Function Improvement in Tennis Elbow: A Randomized Clinical Trial. Pain Res Treat. 2014;2014:191525.
    1. Gerritsen AA, Scholten RJ, Assendelft WJ, Kuiper H, de Vet HC, Bouter LM. Splinting or surgery for carpal tunnel syndrome? Design of a randomized controlled trial [ISRCTN18853827] BMC Neurol. 2001;1:8. doi: 10.1186/1471-2377-1-8.
    1. Kelly EW, Morrey BF, O’Driscoll SW. Complications of elbow arthroscopy. J Bone Joint Surg Am. 2001;83-a(1):25–34.
    1. van Rheenen TA, van den Bekerom MP, Eygendaal D. The incidence of neurologic complications and associated risk factors in elbow surgery: an analysis of 2759 cases. J Shoulder Elb Surg. 2015;24(12):1991–7. doi: 10.1016/j.jse.2015.07.033.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit