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)

Mikkel Bek Clausen; Per Hölmich; Michael Skovdal Rathleff; Thomas Bandholm; Karl Bang Christensen; Mette Kreutzfeldt Zebis; Kristian Thorborg

doi:10.1177/03635465211016008

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)

Mikkel Bek Clausen
, Per Hölmich
, Michael Skovdal Rathleff
, Thomas Bandholm
, Karl Bang Christensen
, Mette Kreutzfeldt Zebis
, Kristian Thorborg

Publikation: Bidrag til tidsskrift › Tidsskriftsartikel › Forskning › peer review

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.

Originalsprog	Engelsk
Tidsskrift	The American Journal of Sports Medicine
Vol/bind	49
Udgave nummer	11
Sider (fra-til)	3040-3049
Antal sider	10
ISSN	0363-5465
DOI	https://doi.org/10.1177/03635465211016008
Status	Udgivet - sep. 2021

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10.1177/03635465211016008

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1 Abstrakt
1 Tidsskriftsartikel
1 Podcast, musik- og lydproduktion

Tanker, smerter, træning og subakromialt smertesyndrom – med Mikkel B. Clausen
Clausen, M. B. (Gæst), 11 dec. 2023
Publikation: Ikke-skriftlig produktion › Podcast, musik- og lydproduktion › Formidling
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)
Clausen, M. B., Hölmich, P., Rathleff, M. S., Bandholm, T., Christensen, K. B., Zebis, M. K. & Thorborg, K., sep. 2021, I: The American Journal of Sports Medicine. 49, 11, s. 3040-3049 10 s.
Publikation: Bidrag til tidsskrift › Tidsskriftsartikel › Forskning › peer review

Åben adgang
Effectiveness Of Adding A Large Dose Of Shoulder Strengthening To Current Non-Operative Care For Subacromial Impingement (The SExSI-Trial)
Clausen, M. B., Hölmich, P., Rathleff, M. S., Bandholm, T., Christensen, K. B., Zebis, M. K. & Thorborg, K., 2021.
Publikation: Konferencebidrag uden forlag/tidsskrift › Abstrakt › Forskning › peer review

SExSI-trial: Strengthening Exercises in Shoulder Impingement
Bandholm, T. (Projektdeltager), Rathleff, M. S. (Projektdeltager), Hölmich, P. (Projektdeltager), Christensen, K. B. (Projektdeltager), Thorborg, K. (Projektdeltager), Graven-Nielsen, T. (Projektdeltager), Clausen, M. B. (Projektleder) & Zebis, M. K. (Projektdeltager)
01/05/16 → 31/12/22
Projekter: Projekt › Forskning

Faglig formidling på højt niveau
Clausen, M. B.
16/05/22
1 Mediebidrag
Presse/medie
Strength training for subacromial impingement - is more better? With Dr Mikkel Bek Clausen
Clausen, M. B.
23/03/22
1 Mediebidrag
Presse/medie
High-volume shoulder strengthening does not improve subacromial impingement outcomes
Clausen, M. B.
10/09/21
1 Mediebidrag
Presse/medie
Talking About SExSI Shoulder Strength with Dr Mikkel Clausen
Clausen, M. B.
17/07/21
1 Mediebidrag
Presse/medie
SExSI Strength
Clausen, M. B.
02/06/21
1 Mediebidrag
Presse/medie
Peter Magnusson får Linhard Prisen for sin "kæmpe indflydelse på fysioterapien"
Clausen, M. B.
21/02/20
1 element af Mediedækning
Presse/medie

Subacromielt smertesyndrom - Ny viden og hvor skal vi hen?
Clausen, M. B. (Oplægsholder)
21 apr. 2023
Aktivitet: Tale, præsentation eller oplæg f.eks. på konferencer og til praksis › Foredrag eller oplæg
Resistance training for shoulder pain syndrome - Sensitization of pain and exercise adherence
Clausen, M. B. (Oplægsholder)
2023
Aktivitet: Tale, præsentation eller oplæg f.eks. på konferencer og til praksis › Foredrag eller oplæg
Subacromial pain syndrome - pain mechanisms, exercise adherence and clinical decisions
Clausen, M. B. (Oplægsholder)
12 okt. 2023
Aktivitet: Tale, præsentation eller oplæg f.eks. på konferencer og til praksis › Foredrag eller oplæg
SECEC-ESSSE Congress 2021
Clausen, M. B. (Deltager)
15 sep. 2021 → 18 sep. 2021
Aktivitet: Deltagelse i eller arrangement af en begivenhed - typer › Konference
Dansk Ortopædkirurgisk Selskabs årskongres (DOS) 2020
Clausen, M. B. (Deltager)
22 okt. 2020
Aktivitet: Deltagelse i eller arrangement af en begivenhed - typer › Konference
Scandinavian Sports Medicine Congress
Clausen, M. B. (Deltager)
30 jan. 2020 → 1 feb. 2020
Aktivitet: Deltagelse i eller arrangement af en begivenhed - typer › Konference

Citationsformater

Clausen, M. B., Hölmich, P., Rathleff, M. S., Bandholm, T., Christensen, K. B., Zebis, M. K., & Thorborg, K. (2021). 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). The American Journal of Sports Medicine, 49(11), 3040-3049. https://doi.org/10.1177/03635465211016008

@article{27c259b49010417bbe8e33ea52c828f6,

title = "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).",

author = "Clausen, \{Mikkel Bek\} and Per H{\"o}lmich and Rathleff, \{Michael Skovdal\} and Thomas Bandholm and Christensen, \{Karl Bang\} and Zebis, \{Mette Kreutzfeldt\} and Kristian Thorborg",

note = "Publisher Copyright: {\textcopyright} 2021 The Author(s).",

year = "2021",

month = sep,

doi = "10.1177/03635465211016008",

language = "English",

volume = "49",

pages = "3040--3049",

journal = "The American Journal of Sports Medicine",

issn = "0363-5465",

publisher = "SAGE Publications",

number = "11",

}

Clausen, MB, Hölmich, P, Rathleff, MS, Bandholm, T, Christensen, KB, Zebis, MK & Thorborg, K 2021, '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)', The American Journal of Sports Medicine, bind 49, nr. 11, s. 3040-3049. https://doi.org/10.1177/03635465211016008

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). / Clausen, Mikkel Bek; Hölmich, Per; Rathleff, Michael Skovdal et al.
I: The American Journal of Sports Medicine, Bind 49, Nr. 11, 09.2021, s. 3040-3049.

Publikation: Bidrag til tidsskrift › Tidsskriftsartikel › Forskning › peer review

TY - JOUR

T1 - Effectiveness of Adding a Large Dose of Shoulder Strengthening to Current Nonoperative Care for Subacromial Impingement:

T2 - A Pragmatic, Double-Blind Randomized Controlled Trial (SExSI Trial)

AU - Clausen, Mikkel Bek

AU - Hölmich, Per

AU - Rathleff, Michael Skovdal

AU - Bandholm, Thomas

AU - Christensen, Karl Bang

AU - Zebis, Mette Kreutzfeldt

AU - Thorborg, Kristian

PY - 2021/9

Y1 - 2021/9

N2 - 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).

AB - 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).

UR - https://www.scopus.com/pages/publications/85106696692

U2 - 10.1177/03635465211016008

DO - 10.1177/03635465211016008

M3 - Journal article

C2 - 34048281

SN - 0363-5465

VL - 49

SP - 3040

EP - 3049

JO - The American Journal of Sports Medicine

JF - The American Journal of Sports Medicine

IS - 11

ER -

Clausen MB, Hölmich P, Rathleff MS, Bandholm T, Christensen KB, Zebis MK et al. 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). The American Journal of Sports Medicine. 2021 sep.;49(11):3040-3049. doi: 10.1177/03635465211016008

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)

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