Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up

Mathias Bäck, Mika Paavola, Pasi Aronen, Teppo L N Järvinen, Simo Taimela, Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators, Mathias Bäck, Mika Paavola, Pasi Aronen, Teppo L N Järvinen, Simo Taimela, Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators

Abstract

Background: Arthroscopic subacromial decompression is one of the most commonly performed shoulder surgeries in the world. It is performed to treat patients with suspected shoulder impingement syndrome, i.e., subacromial pain syndrome. Only few studies have specifically assessed return-to-work rates after subacromial decompression surgery. All existing evidence comes from open, unblinded study designs and this lack of blinding introduces the potential for bias. We assessed return to work and its predictors in patients with shoulder impingement syndrome in a secondary analysis of a placebo-surgery controlled trial.

Methods: One hundred eighty-four patients in a randomised trial had undergone arthroscopic subacromial decompression (n = 57), diagnostic arthroscopy, a placebo surgical intervention, (n = 59), or exercise therapy (n = 68). We assessed return to work, defined as having returned to work for at least two follow-up visits by the primary 24-month time point, work status at 24 and 60 months, and trajectories of return to work per follow-up time point. Patients and outcome assessors were blinded to the assignment regarding the arthroscopic subacromial decompression vs. diagnostic arthroscopy comparison. We assessed the treatment effect on the full analysis set as the difference between the groups in return-to-work rates and work status at 24 months and at 60 months using Chi-square test and the predictors of return to work with logistic regression analysis.

Results: There was no difference in the trajectories of return to work between the study groups. By 24 months, 50 of 57 patients (88%) had returned to work in the arthroscopic subacromial decompression group, while the respective figures were 52 of 59 (88%) in the diagnostic arthroscopy group and 61 of 68 (90%) in the exercise therapy group. No clinically relevant predictors of return to work were found. The proportion of patients at work was 80% (147/184) at 24 months and 73% (124/184) at 60 months, with no difference between the treatment groups (p-values 0.842 and 0.943, respectively).

Conclusions: Arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy or exercise therapy on return to work in patients with shoulder impingement syndrome. We did not find clinically relevant predictors of return to work either.

Trial registration: ClinicalTrials.gov identifier NCT00428870 .

Keywords: Exercise therapy; Placebo surgery; Randomised controlled trial; Return to work; Subacromial decompression; Subacromial pain.

Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: ST reports personal fees from Terveystalo group of companies and from DBC group of companies, outside the submitted work. Authors not named here have disclosed no conflicts of interest.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the Full Analysis Set
Fig. 2
Fig. 2
Trajectories of RTW. The Y-axis shows the proportion of patients at work (%) at each follow-up time point. The scale of X-axis is months. A Trajectories by treatment group: ASD denotes arthroscopic subacromial decompression, DA diagnostic arthroscopy, and ET exercise therapy. B Trajectories by baseline work status

References

    1. Vitale MA, Arons RR, Hurwitz S, et al. The rising incidence of acromioplasty. J Bone Joint Surg Am. 2010;92(9):1842–1850. doi: 10.2106/JBJS.I.01003.
    1. Karjalainen TV, Jain NB, Page CM, et al. Subacromial decompression surgery for rotator cuff disease. Cochrane Database Syst Rev. 2019;1:CD005619.
    1. Vandvik PO, Lahdeoja T, Ardern C, et al. Subacromial decompression surgery for adults with shoulder pain: a clinical practice guideline. BMJ. 2019;364:l294. doi: 10.1136/bmj.l294.
    1. Beard DJ, Rees JL, Cook JA, et al. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018;391(10118):329–338. doi: 10.1016/S0140-6736(17)32457-1.
    1. Paavola M, Malmivaara A, Taimela S, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ. 2018;362:k2860. doi: 10.1136/bmj.k2860.
    1. Hata Y, Saitoh S, Murakami N, et al. A less invasive surgery for rotator cuff tear: mini-open repair. J Shoulder Elb Surg. 2001;10(1):11–16. doi: 10.1067/mse.2001.110514.
    1. Coghlan JA, Buchbinder R, Green S, et al. Surgery for rotator cuff disease. Cochrane Database Syst Rev. 2008;1:CD005619.
    1. Ketola S, Lehtinen J, Arnala I, et al. Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: a two-year randomised controlled trial. J Bone Joint Surg Br. 2009;91(10):1326–1334. doi: 10.1302/0301-620X.91B10.22094.
    1. Haahr JP, Ostergaard S, Dalsgaard J, et al. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis. 2005;64(5):760–764. doi: 10.1136/ard.2004.021188.
    1. Paavola M, Malmivaara A, Taimela S, et al. Finnish subacromial impingement arthroscopy controlled trial (FIMPACT): a protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome. BMJ Open. 2017;7(5):e014087. doi: 10.1136/bmjopen-2016-014087.
    1. Paavola M, Kanto K, Ranstam J, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial. Br J Sports Med. 2020.
    1. Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990;254:64–74.
    1. Brox JI, Staff PH. Ljunggren AE, et al. Arthroscopic surgery compared with supervised exercises in patients with rotator cuff disease (stage II impingement syndrome) BMJ. 1993;307(6909):899–903. doi: 10.1136/bmj.307.6909.899.
    1. Ellman H. Arthroscopic subacromial decompression: analysis of one- to three-year results. Arthroscopy. 1987;3(3):173–181. doi: 10.1016/S0749-8063(87)80061-0.
    1. Tashjian RZ, Deloach J, Porucznik CA, et al. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elb Surg. 2009;18(6):927–932. doi: 10.1016/j.jse.2009.03.021.
    1. Brox JI, Gjengedal E, Uppheim G, et al. Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): a prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up. J Shoulder Elb Surg. 1999;8(2):102–111. doi: 10.1016/S1058-2746(99)90001-0.
    1. Haahr JP, Andersen JH. Exercises may be as efficient as subacromial decompression in patients with subacromial stage II impingement: 4-8-years' follow-up in a prospective, randomized study. Scand J Rheumatol. 2006;35(3):224–228. doi: 10.1080/03009740600556167.
    1. Ketola S, Lehtinen JT, Arnala I. Arthroscopic decompression not recommended in the treatment of rotator cuff tendinopathy: a final review of a randomised controlled trial at a minimum follow-up of ten years. Bone Joint J. 2017;99-B(6):799–805. doi: 10.1302/0301-620X.99B6.BJJ-2016-0569.R1.
    1. Ketola S, Lehtinen J, Rousi T, et al. No evidence of long-term benefits of arthroscopicacromioplasty in the treatment of shoulder impingement syndrome: five-year results of a randomised controlled trial. Bone Joint Res. 2013;2(7):132–139. doi: 10.1302/2046-3758.27.2000163.
    1. Engebretsen K, Grotle M, Bautz-Holter E, et al. Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain. BMC Musculoskelet Disord. 2010;11:218. doi: 10.1186/1471-2474-11-218.
    1. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557–568. doi: 10.1056/NEJMoa0900429.
    1. Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347(2):81–88. doi: 10.1056/NEJMoa013259.
    1. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569–579. doi: 10.1056/NEJMoa0900563.
    1. Buchbinder R. Meniscectomy in patients with knee osteoarthritis and a meniscal tear? N Engl J Med 2013;Epub date march 18, 2013.
    1. Etuknwa A, Daniels K, Eib C. Sustainable return to work: a systematic review focusing on personal and social factors. J Occup Rehabil. 2019;29(4):679–700. doi: 10.1007/s10926-019-09832-7.
    1. Farfaras S, Sernert N, Hallstrom E, et al. Comparison of open acromioplasty, arthroscopic acromioplasty and physiotherapy in patients with subacromial impingement syndrome: a prospective randomised study. Knee Surg Sports Traumatol Arthrosc. 2016;24(7):2181–2191. doi: 10.1007/s00167-014-3416-4.

Source: PubMed

3
Prenumerera