Strengthening Exercises in Shoulder Impingement (SExSI) Trial

NCT02747251 | Completed

• 1 other identifier: H-16016763
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of a high dose of simple home-based elastic band strengthening exercises to usual care in patients with subacromial impingement syndrome. Half of the participants receive instructions in simple home-based elastic band strengthening exercises in addition to usual care, while the other half receive usual care.

Conditions

Subacromial Impingement Syndrome

Keywords

"Shoulder Impingement Syndrome"[Mesh]; "Rehabilitation"[Mesh]; "Exercise"[Mesh]; "Rotator Cuff"[Mesh]

Outcome Measures

Primary Outcomes (1)

• SPADI

  Shoulder Pain And Disability Index score (continuous) For all continuous outcomes with Time Frame 16 weeks, a constrained Linear Mixed Model (cLMM) is applied to compare the change from baseline to 16 weeks in the intervention group (IG) to that in the control group (CG), with the outcome at 16 weeks as dependent variable, treatment group (IG or CG) as main effect and both baseline score and any additional follow up measurements as repeated measurements. The covariance structures will be selected based on the MAICE procedure. These analyses will be conducted as intention to treat (ITT) analyses, including all randomized participants, regardless of protocol adherence. Participants will be analysed as randomized.

  16 weeks

Secondary Outcomes (23)

• Abduction strength

  16 weeks

• External rotation strength

  16 weeks

• Abduction ROM

  16 weeks

• Pain last week

  16 weeks

• QoL-index

  16 weeks

Study Arms (2)

Strengthen your Shoulder & Usual Care

EXPERIMENTAL

Instructions in a home-based intervention consisting of progressive high volume resistance training with an elastic band. Instructions provided 0, 2, 5, and 10 weeks after baseline. Usual care includes all treatment received by a patient during the time between baseline and follow-up, except that included in "Strengthen your Shoulder".

Other: Strengthen your Shoulder; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

Includes all treatment received by a patient during the time between baseline and follow-up, except that included in "Strengthen your Shoulder".

Other: Usual Care

Interventions

Strengthen your Shoulder OTHER

A simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band.

Strengthen your Shoulder & Usual Care

Usual Care OTHER

Usual care, consisting of a referral to general rehabilitation in the municipal under the Danish Health Act § 140, most often with the alternative option to choose a private physiotherapeutic clinic, partly at their own expense. Also includes any additional treatment the patient receives between baseline and follow-up, except that included in "Strengthen your Shoulder".

Strengthen your Shoulder & Usual Care; Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Convened for the first time to the clinic, for examination of their current shoulder disorder
• Shoulder disorder lasting at least three months
• Living in Capitol Region of Denmark
• Not pregnant
• Do not permanently use strong pain medication
• Able to understand spoken and written Danish
• ≥3 positive of the five diagnostic test for subacromial impingement syndrome (Hawkins-Kennedy test, Neer's test, pain-full arc, Resisted External Rotation test and Jobe's test)
• Offered a rehabilitation plan due to a medically justified need for general rehabilitation after discharge from the hospital under the Danish Health Act § 140.
• Completed Shoulder Pain And Disability Index (SPADI) questionnaire on the day of the medical examination

You may not qualify if:

• A radiologically verified new or previous fracture related to the shoulder joint, including the scapula
• Clinically suspected Glenohumeral osteoarthritis
• A clinically suspected luxation or sub-luxation of the glenohumeral, acromioclavicular or sternoclavicular joint
• A clinically suspected labral lesion, complete tear of the rotator cuff, frozen shoulder or other competing diagnoses (i.e. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, psychiatric illness)

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Metropolitan University College: collaborator
• University of Copenhagen: collaborator
• Aalborg University: collaborator

Study Sites (1)

Orthopaedic Department, Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (4)

• Clausen MB, Krohn LM, Rathleff MS, Bandholm T, Jensen SN, Christensen KB, Holmich P, Thorborg K. The Effect of Adding a Large Dose of Shoulder Strengthening to Nonoperative Care for Subacromial Impingement on Shoulder Disability, Quality of Life, Sick Days, and Surgery Rates: 1-Year Results From a Pragmatic, Double-Blind Randomized Controlled Trial (SExSI). Orthop J Sports Med. 2025 Oct 20;13(10):23259671251374314. doi: 10.1177/23259671251374314. eCollection 2025 Oct.

  PMID: 41140544 DERIVED

• Clausen MB, Rathleff MS, Graven-Nielsen T, Bandholm T, Christensen KB, Holmich P, Thorborg K. Level of pain catastrophising determines if patients with long-standing subacromial impingement benefit from more resistance exercise: predefined secondary analyses from a pragmatic randomised controlled trial (the SExSI Trial). Br J Sports Med. 2023 Jul;57(13):842-848. doi: 10.1136/bjsports-2022-106383. Epub 2023 Mar 10.

  PMID: 36898767 DERIVED

• Clausen MB, Holmich P, Rathleff M, Bandholm T, Christensen KB, Zebis MK, Thorborg K. 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). Am J Sports Med. 2021 Sep;49(11):3040-3049. doi: 10.1177/03635465211016008. Epub 2021 May 28.

  PMID: 34048281 DERIVED

• Clausen MB, Bandholm T, Rathleff MS, Christensen KB, Zebis MK, Graven-Nielsen T, Holmich P, Thorborg K. 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. Trials. 2018 Mar 2;19(1):154. doi: 10.1186/s13063-018-2509-7.

  PMID: 29499710 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Mikkel B Clausen, PhD-Student

  Bachelor's Degree Programme in Physiotherapy, Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, Metropolitan University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-Student

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: May 13, 2016
• Primary Completion: October 29, 2018
• Study Completion: July 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

DK (1)