The Strengthening Exercises in Shoulder Impingement trial (The SExSI-trial) investigating the effectiveness of a simple add-on shoulder strengthening exercise programme in patients with long-lasting subacromial impingement syndrome: Study protocol for a pragmatic, assessor blinded, parallel-group, randomised, controlled trial

Abstract

BackgroundSubacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-lasting SIS. However, the current rehabilitation of such strength impairments may be inadequate, with novel rehabilitation programmes including exercise therapy only improving external rotation strength by 4–13%.As these previous studies are the basis of current practice, this suggests that the strengthening component could be inadequate in the rehabilitation of these patients, and it seems likely that more emphasis should be placed on intensifying this part of the rehabilitation.The purpose of this study is to investigate the effectiveness of a programme consisting of progressive home-based resistance training using an elastic band, aimed at improving shoulder external rotation and abduction strength, added to usual care and initiated shortly after diagnosis has been established.MethodsA pragmatic randomised controlled superiority trial will be conducted, including 200 patients with pronounced and long-lasting SIS, diagnosed using predefined criteria. Participants will be randomised to receive either an add-on intervention of progressive home-based resistance training using an elastic band in addition to usual care or usual care alone in a 1:1 allocation ratio. The randomisation sequence is computer generated, with permuted blocks of random sizes. The primary outcome will be change in Shoulder Pain And Disability Index (SPADI) score from baseline to 16 weeks follow-up. Outcome assessors are blinded to group allocation. Intervention receivers will be kept blind to treatment allocation through minimal information about the content of the add-on intervention and control condition until group allocation is final. Analyses are performed by blinded data analysts.DiscussionIf effective, the simple shoulder strengthening exercise programme investigated in this trial could easily be added to usual care. The usefulness of the trial is further supported by the magnitude of the problem, the information gained from the study and the pragmatism, patient centeredness and transparency of the trial.Trial registrationThe trial is pre-registered at ClinicalTrials.gov with the ID NCT02747251 on April 19, 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2509-7) contains supplementary material, which is available to authorized users.

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)

“…Dichotomous secondary outcomes for treatment success included the Patient Acceptable Symptom State (PASS; acceptable/ unacceptable) and global impression of change (recovered or much improved, yes/no). Additional secondary outcomes will be reported in subsequent publications, as outlined in the trial protocol 10 and registration (ClinicalTrials.gov NCT02747251) (see the Appendix, available online).…”

“…We applied constrained linear mixed models to compare the change in the IG with that in the CG, as described in the trial protocol. 10 Similar analyses were conducted for all continuous secondary outcomes. Dichotomous outcomes were compared between groups using chi-square tests.…”

“…The full trial protocol describing its methodology is available via open access. 10 There were no deviations from the protocol after the trial began, except for the addition of a post hoc sensitivity analysis. Ethics approval was obtained from the regional ethics committee of the Capital Region of Denmark (approval No.…”

“…Supervised exercise instructions were provided at baseline and after 2, 5, and 10 weeks, with a final supervised instruction provided after the last follow-up (4 months) to allow participants to continue with the program should they wish to. A full description of the intervention, following the template for intervention description and replication (TIDieR) guidelines, 22 and the rationale to support it are available via open access, 10 and educational videos of the exercises are available at https://video.kp.dk/playlist/dedi cated/418727/0_m91947x6/.…”

Spinal Manipulation and Electrical Dry Needling in Patients With Subacromial Pain Syndrome: A Multicenter Randomized Clinical Trial

“…20,23,46,57 Second, we did not prescribe a home exercise program for either group in this study, as nonadherence has been reported in up to 70% of patients, 21 exercise diaries appear to be unreliable, 71 and many patients fail to appropriately dose or correctly perform their home exercise program. 11,22 Third, we did not use a placebo needling or control group. Although we recognize the use of a placebo needling group as an ideal situation, 45 our goal was to compare the novel intervention (TMEDN) to a more common physical therapy intervention (NTMEX) to more accurately determine the new treatment's effect size, 20,23,57 without the potential for an inflated between-group effect size.…”