Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Mar 2;19(1):154.
doi: 10.1186/s13063-018-2509-7.

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

Mikkel Bek Clausen  1   2   3 , Thomas Bandholm  4   5 , Michael Skovdal Rathleff  6   7 , Karl Bang Christensen  8 , Mette Kreutzfeldt Zebis  9 , Thomas Graven-Nielsen  10 , Per Hölmich  11 , Kristian Thorborg  11   4
Affiliations

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

Mikkel Bek Clausen et al. Trials. .

Abstract

Background: Subacromial 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.

Methods: A 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.

Discussion: If 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 registration: The trial is pre-registered at ClinicalTrials.gov with the ID NCT02747251 on April 19, 2016.

Keywords: Adherence; Exercise; Impingement; Pragmatic; Progressive; RCT; Rotator cuff; Sensitisation; Shoulder; Strength.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The trial protocol, the informed consent forms and other requested documents have been reviewed and approved by the Capitol Regional Ethics Committee in Denmark (H-16016763) with respect to the scientific content and the compliance to the applicable health science regulations. Safety reports, containing a list of all serious side effects and serious events, will be sent to the ethics committee. Within 90 days after completion of the study, the sponsor and the primary investigator will inform the ethics committee that the study is closed.

Consent or assent

At the end of the medical examination, the treating orthopaedic specialist or the cooperating nurse will introduce the trial to patients fulfilling the eligibility criteria. Patients will be informed about the request for participation in the trial, and will be provided with participant information and a brochure on test subject’s rights. As soon as possible thereafter, patients will be contacted by one of the investigators. A final eligibility screening will be conducted and eligible patients will be offered a meeting to provide oral information about the trial, their rights as test subjects and the possibility to ask clarifying questions. Patients are offered deliberation time before being asked to sign written consent forms regarding willingness to participate.

Consent or assent – ancillary studies

In the oral information and in the participant information sheets, patients will be informed that a 1 year follow-up is planned for all participants, and that this is covered by the written consent forms. Data for the 1 year follow-up will, in part, be collected through text messages, using the SMS-track© (data hosted at a BFIH certified data centre that meets the ISO 27002 standards). Through answers to auto-generated standardized SMS questions, patients will be asked to report sick leave due to their shoulder disorder (weekly). Questions regarding surgery, if any, for SIS (yearly), the EQ-5D-3 L questionnaire (yearly), and all questions from the SPADI questionnaire (after 6 months and 1 year) will be administered using the REDCap® system.

Confidentiality

All study-related information on participants will be stored securely on the study site. All completed paper forms will be stored in locked file cabinets before and after data is entered to an electronic database. All electronic participants’ information will be stored on a secured study-specific drive at the study site. Access to the study-specific drive will be limited to users currently working on the project and therefore need access to the secured drive in order to store and/or analyse data. Access will be limited by individual person-specific login and passwords. A list of persons with access to the study-specific drive will be kept up-to-date by the primary investigator. Appointment schedules and any other listings that link participant to other identifying information will be stored separately in the hospital’s secured intranet system or in separate locked file cabinets in an area with limited access. Study information will not be released outside of the study without the permission of the relevant participant. The study will be reported to and approved by the Danish Data Protection Agency before start of inclusion, and will adhere to the “Act on Processing Personal Data”.

Ancillary and post-trial care

In general, no ancillary or post-trial care is provided to participants in the trial. However, the details of the intervention will be made public shortly after the trial is over, and the intervention could therefore be replicated by physiotherapists in ordinary settings.

Consent for publication

Written informed consent for publication of images in the intervention leaflet was obtained from the person appearing on the pictures. A copy of the consent form is available for review by the Editor of this journal.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Summary of measures to be collected (SPIRIT figure)
Fig. 2
Fig. 2
Visualisation of changes in SPADI score in the intervention and control group, respectively (example, not based on data)
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Steinfeld R, Valente RM, Stuart MJ. A commonsense approach to shoulder problems. Mayo Clin Proc. 1999;74:785–794. doi: 10.4065/74.8.785. - DOI - PubMed
    1. van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995;54:959–964. doi: 10.1136/ard.54.12.959. - DOI - PMC - PubMed
    1. van der Windt DA, Koes BW, Boeke AJ, Devillé W, De Jong BA, Bouter LM. Shoulder disorders in general practice: prognostic indicators of outcome. Br J Gen Pract J R Coll Gen Pract. 1996;46:519–523. - PMC - PubMed
    1. MacDermid JC, Ramos J, Drosdowech D, Faber K, Patterson S. The impact of rotator cuff pathology on isometric and isokinetic strength, function, and quality of life. J Shoulder Elb Surg. 2004;13:593–598. doi: 10.1016/j.jse.2004.03.009. - DOI - PubMed
    1. Sundhedsstyrelsen . Impingementsyndrom/rotator cuff-syndrom og traumatisk rotator cuff-ruptur Del 2: Faglige visitationsretningslinjer. København: Sundhedsstyrelsen; 2011.

Publication types

MeSH terms

Associated data