Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation

Cederqvist, Sanna; Flinkkilä, Tapio; Sormaala, Markus J.; Ylinen, Jari; Kautiainen, Hannu; Irmola, Tero; Lehtokangas, Heidi; Liukkonen, Juho; Pamilo, Konsta; Ridanpää, Tero; Sirniö, Kai; Kiviranta, Ilkka; Paloneva, Juha

doi:10.1136/annrheumdis-2020-219099

Cited by 28 publications

(21 citation statements)

References 31 publications

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“…Along these lines, it is worth noting that recent knowledge indicates a short-term effect of interventions including surgery for subacromial impingement when used as part of a second-line treatment approach. 5 In the study by Cederqvist et al, 5 patients were first prescribed a 3- to 4-month physical therapist−led exercise intervention, and patients who failed this approach were randomized to either continuation of the previously initiated rehabilitation program or a surgical intervention. At 3 months after randomization, between-group differences in improvements were in favor of the surgery group, with differences of 10 to 15 points on the VAS.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Adding a Large Dose of Shoulder Strengthening to Current Nonoperative Care for Subacromial Impingement: A Pragmatic, Double-Blind Randomized Controlled Trial (SExSI Trial)

et al. 2021

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Background: A strong recommendation against subacromial decompression surgery was issued in 2019. This leaves nonoperative care as the only treatment option, but recent studies suggest that the dose of strengthening exercise is not sufficient in current nonoperative care. At this point, it is unknown if adding more strengthening to current nonoperative care is of clinical value. Purpose: To assess the effectiveness of adding a large dose of shoulder strengthening to current nonoperative care for subacromial impingement compared with usual care alone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this double-blinded, pragmatic randomized controlled trial, we randomly allocated 200 consecutive patients referred to orthopaedic shoulder specialist care for long-standing shoulder pain (>3 months), aged 18 to 65 years and diagnosed with subacromial impingement using validated criteria, to the intervention group (IG) or control group (CG). Outcome assessors were blinded, and participants were blinded to the study hypothesis as well as to the treatment method in the other group. The CG received usual nonoperative care; the IG underwent the same plus an add-on intervention designed to at least double the total dose of shoulder strengthening. The primary outcome was the Shoulder Pain and Disability Index (SPADI; 0-100) at 4-month follow-up, with 10 points defined as the minimal clinically important difference. Secondary outcomes included shoulder strength, range of motion, health-related quality of life, and the Patient Acceptable Symptom State (PASS). Results: Intention-to-treat and per-protocol analyses showed no significant or clinically relevant between-group differences for any outcome. From baseline to 4-month follow-up, SPADI scores improved in both groups (intention-to-treat analysis; IG, –22.1 points; CG, –22.7 points; between-group mean difference, 0.6 points [95% CI, –5.5 to 6.6]). At 4 months after randomization, only 54% of the IG and 48% of the CG ( P = .4127) reached the PASS. No serious adverse events were reported. Conclusion: Adding a large dose of shoulder strengthening to current nonoperative care for patients with subacromial impingement did not result in superior shoulder-specific patient-reported outcomes. Moreover, approximately half of all randomized patients did not achieve the PASS after 4 months of nonoperative care, leaving many of these patients with unacceptable symptoms. This study showed that adding more exercise is not a viable solution to this problem. Registration: NCT02747251 ( ClinicalTrials.gov identifier)

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Section: Discussionmentioning

confidence: 99%

Effectiveness of Adding a Large Dose of Shoulder Strengthening to Current Nonoperative Care for Subacromial Impingement: A Pragmatic, Double-Blind Randomized Controlled Trial (SExSI Trial)

et al. 2021

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“…Longer follow-up and the results of ongoing studies are needed to evaluate the optimal treatment for trauma-related rotator cuff tears. 34 In the latest randomized trial comparing nonsurgical and surgical treatments for rotator cuff disease, Cederqvist et al 4 reported that surgery yielded superior improvement in pain and function in patients with full-thickness rotator cuff tears at 2-year follow-up. This study also included larger rotator cuff tears comprising not only the supraspinatus tendon.…”

Section: Discussionmentioning

confidence: 99%

Operative versus conservative treatment of small, nontraumatic supraspinatus tears in patients older than 55 years: over 5-year follow-up of a randomized controlled trial

Kukkonen¹,

Ryösä²,

Lehtinen³

et al. 2021

Journal of Shoulder and Elbow Surgery

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Background: Nontraumatic rotator cuff tear is a common shoulder problem that can be treated either conservatively or operatively. In the previous publications of the 1-and 2-year results of this trial, we found no significant between-group clinical differences. The aim of this study was to investigate the differences in mid-term clinical and radiologic outcomes in patients older than 55 years. Materials and methods: One hundred eighty shoulders with symptomatic, nontraumatic supraspinatus tears were randomly assigned to 1 of the 3 cumulatively designed treatment groups: physiotherapy (group 1); acromioplasty and physiotherapy (group 2); and rotator cuff repair, acromioplasty, and physiotherapy (group 3). The change in the Constant score was the primary outcome measure. The secondary outcome measures were the change in the visual analog scale score for pain and patient satisfaction. Radiologic analysis included evaluation of glenohumeral osteoarthritis (OA) and rotator cuff tear arthropathy (CTA). Results: A total of 150 shoulders (mean age, 71 years) were available for analysis after a mean follow-up period of 6.2 years. The mean sagittal tear size of the supraspinatus tendon tear at baseline was 10 mm in all groups (P ¼ .33). During follow-up, 8 shoulders in group 1 and 2 shoulders in group 2 crossed over to rotator cuff repair. The mean baseline Constant score was 57.1, 58.2, and 58.7 in groups 1, 2, and 3, respectively (P ¼ .85). There were no significant differences (P ¼ .84) in the mean change in the Constant score: 18.5 in group 1, 17.9 in group 2, and 20.0 in group 3. There were no statistically significant differences in the change in the visual analog scale pain score (P ¼ .74) and patient satisfaction (P ¼ .83). At follow-up, there were no statistically significant differences in the mean progression of glenohumeral OA (P ¼ .538) or CTA (P ¼ .485) among the groups. However, the mean progression of glenohumeral OA from baseline to follow-up was statistically significant in the trial population (P ¼ .0045). Conclusions: On the basis of this study, operative treatment is no better than conservative treatment regarding small, nontraumatic, single-tendon supraspinatus tears in patients older than 55 years. Operative treatment does not protect against degeneration of the glenohumeral joint or CTA. Conservative treatment is a reasonable option for the primary initial treatment of these tears.The Ethics Committee of the Hospital District of South-West Finland approved this study (ETMK 106/180/2007), and the study protocol was registered at ClinicalTrials.gov (NCT01116518).

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“…1 Our randomised, pragmatic, controlled trial compared surgical and non-surgical treatments for rotator cuff disease (RCD) with or without full-thickness tendon tears after unsuccessful initial rehabilitation. 2 Randelli and coworkers commented that the power of our study lies in the fact that potential eligible patients underwent a systematic, adequately performed 3-month rehabilitation, after which only patients who remained symptomatic were randomised; we agree. Symptoms alleviated in 102 of the 417 shoulders with chronic RCD (mean duration of symptoms 9 months before recruitment) during the 3 month, pragmatic nonoperative treatment.…”

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confidence: 61%

Response to: ‘Correspondence on ‘Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation’’ by Randelliet al

et al. 2021

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Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation

Cited by 28 publications

References 31 publications

Effectiveness of Adding a Large Dose of Shoulder Strengthening to Current Nonoperative Care for Subacromial Impingement: A Pragmatic, Double-Blind Randomized Controlled Trial (SExSI Trial)

Effectiveness of Adding a Large Dose of Shoulder Strengthening to Current Nonoperative Care for Subacromial Impingement: A Pragmatic, Double-Blind Randomized Controlled Trial (SExSI Trial)

Operative versus conservative treatment of small, nontraumatic supraspinatus tears in patients older than 55 years: over 5-year follow-up of a randomized controlled trial

Response to: ‘Correspondence on ‘Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation’’ by Randelliet al

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