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)

Abstract

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)

Short-term effectiveness of high-load compared with low-load strengthening exercise on self-reported function in patients with hypermobile shoulders: a randomised controlled trial

“…Our findings, although non-significant, regarding the between-group difference in muscle strength in favour of HEAVY (scaption 10.4%, external rotation 12%) and the trend in less positive clinical tests (an indirect measure of muscle-tendon stiffness) may explain some of the effect of HEAVY on self-reported shoulder function and decreased physical symptoms. However, considering that several studies on shoulder pain-related conditions have failed to show superiority of progressive high-load strengthening exercise could indicate that other factors than the physical response to load are important 19 69 70. Other factors may include the different types of exercise used in HEAVY and LIGHT (eg, full range or not) and the benefits of supervised and individually graded exercise to restore the ability of daily activities.…”

Tailored exercise and manual therapy versus standardised exercise for patients with shoulder subacromial pain: a feasibility randomised controlled trial (the Otago MASTER trial)

“…This may explain why most of our participants presented mild to moderate pain intensity. Participants in our study presented lower pain or function scores compared with those from previous full trials 8 10 65 66. For the full trial, we plan to adopt a multimodal recruitment strategy, including general practice clinics, social media and waiting list from local hospitals.…”

“…Best evidence recommends exercise therapy be prescribed for patients with shoulder subacromial pain 7 8. However, the strength of evidence supporting this recommendation is limited and findings from two large trials found exercise therapy did not provide additional benefit over usual care 9 10. On the other hand, a recent systematic review and network meta-analysis suggested that, among other interventions, exercise and manual therapy are likely to be effective in the short term for pain and function outcomes 11.…”

Writing up your clinical trial report for a scientific journal: the REPORT trial guide for effective and transparent research reporting without spin

“…Because this issue relates to external validity it is important—but it is especially important if the trial findings have major implications for current clinical practice. Please see Clausen et al 58 for an example of how the number of potentially eligible participants can be incorporated into the trial flow chart. Please also see the rapid responses 59 to the FIMPACT 60 trial for a discussion of the importance of including the number of potentially eligible participants when trial findings have great implications for clinical practice.…”