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Strengthening Exercises in Shoulder Impingement (SExSI) Trial

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Strengthen your Shoulder
Usual Care
Sponsored by
Copenhagen University Hospital, Hvidovre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring "Shoulder Impingement Syndrome"[Mesh], "Rehabilitation"[Mesh], "Exercise"[Mesh], "Rotator Cuff"[Mesh]

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Orthopaedic Department, Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strengthen your Shoulder & Usual Care

Usual Care

Arm Description

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".

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Abduction strength
Maximum isometric voluntary contraction in shoulder abduction (continuous)
External rotation strength
Maximum isometric voluntary contraction in shoulder external rotation (continuous)
Abduction ROM
Active range of motion in shoulder abduction (continuous)
Pain last week
The average of least pain and average pain last week (continuous)
QoL-index
Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)
QoL-index
Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)
QoL-VAS
Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)
QoL-VAS
Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)
PCS
Pain Catastrophizing measured using the Pain Catastrophizing Scale (continuous)
Temporal summation of pain (TS)
The increase in pain recorded on an electronic VAS scale (range: 0-10 cm), during repeated standardized pressure induced pain stimuli (continuous)
CPM-Threshold
Conditioned pain threshold modulation, the percent increase in pressure pain tolerance threshold, when experimental tonic pain is induced (continuous)
CPM-Detection
Conditioned pain detection modulation, the percent increase in pressure pain detection threshold , when experimental tonic pain is induced (continuous)
PPT-deltoid
Pain pressure threshold at the deltoid muscle: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
PPT-Supraspinatus
Pain pressure threshold at the supraspinatus muscle: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
PPT-Infraspinatus
Pain pressure threshold at the infraspinatus muscle: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
PPT-worst
Pain pressure threshold at the site of worst pain: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
Sick leave
The number of days with reported sick leave due to shoulder disorder (continuous)
Global impression of change
Much improved or recovered? (Binary) Binary outcomes will be reported as proportions with corresponding 95% confidence intervals, and will be compared using a Chi-squared tests, and Odds Ratios computed from random effects logistic regression models.
PASS
Patient Acceptable Symptom State: Is the symptom state acceptable? (Binary)
Surgery
Surgery performed for the shoulder disorder? (Binary)
SDT
Scapula dyskinesia measured using the Scapula Dyskinesia Test (Binary)
mSAT
Scapula dysfunction measured using the modified Scapula Assistance Test (Binary)
SPADI
Shoulder Pain And Disability Index score (continuous)

Full Information

First Posted
April 19, 2016
Last Updated
January 22, 2020
Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Metropolitan University College, University of Copenhagen, Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT02747251
Brief Title
Strengthening Exercises in Shoulder Impingement (SExSI) Trial
Official Title
The Effects of Additional Home-based Strengthening Exercises in Shoulder Impingement Rehabilitation (The SEXSI-Trial): A Pragmatic Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Metropolitan University College, University of Copenhagen, Aalborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The SEXSI trial is a pragmatic, assessor and participant blinded, randomized, controlled, superiority trial, with a two-group parallel design. Patients with subacromial impingement syndrome will be randomized to either usual care or a home-based intervention consisting of progressive high volume resistance training in addition to usual care using a 1:1 allocation. The primary end-point will be change in the Shoulder Pain and Disability Index (SPADI) 16 weeks after baseline. The overall frame for the trial is a main clinical effectiveness-part and an embedded mechanistic part. The clinical effectiveness-part will be reported in the main trial paper, and include the following outcomes: SPADI (primary outcome), Abduction strength, External rotation strength, Abduction ROM, Pain last week, QoL-index, QoL-VAS, Global impression of change and PASS. Missing outcome data will be imputed using multiple imputations based on the following variables: All previous scores in the relevant outcome, Age, Gender and Allocation. A full trial protocol will be published and made publicly available. A constrained Linear Mixed Model (cLMM) will be applied for all continuous outcomes with Time Frame 16 weeks (including the primary outcome), to compare the change from baseline to 16 weeks in the intervention group (IG) to that in the control group (CG). The outcome at 16 weeks will be included 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. Binary outcomes will be reported as proportions with corresponding 95% confidence intervals, and will be compared using Chi-squared tests, and Odds Ratios computed from random effects logistic regression models. All of these analyses will be conducted as intention to treat (ITT) analyses, including all randomized participants, regardless of protocol adherence, meaning that all participants will be analysed as randomized. In the primary trial report, all collected outcomes will be listed, and it will be stated that the below-mentioned variables - belonging to the mechanistic part - will be reported in secondary publications. The mechanistic part will be reported in secondary papers with a clear reference to the primary trial and trial registration, and it will hold the label "secondary analyses from a pragmatic randomized controlled trial" in the title. The following outcomes will be reported: Outcomes regarding pain sensitization (temporal summation of pain, conditioned pain modulation, pain pressure threshold and pain catastrophizing) will be reported in a subsequent paper where we also plan to investigate: the modifying effects of pain sensitization on the effectiveness of the add-on intervention the dose-response relationship between objectively monitored adherence to the add-on intervention and change in SPADI, shoulder abduction strength and external rotation strength the dose-response relationship between pain sensitization and change in SPADI, shoulder abduction strength and external rotation strength, and to what degree this is mediated through adherence to the intervention. Outcomes regarding scapula dyskinesia and scapula dysfunction will be reported in another subsequent paper, were we also plan to investigate the modifying effects of scapula dyskinesia and scapula dysfunction on the effectiveness of the intervention on changes in SPADI, abduction strength and external rotation strength.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
"Shoulder Impingement Syndrome"[Mesh], "Rehabilitation"[Mesh], "Exercise"[Mesh], "Rotator Cuff"[Mesh]

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strengthen your Shoulder & Usual Care
Arm Type
Experimental
Arm Description
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".
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Includes all treatment received by a patient during the time between baseline and follow-up, except that included in "Strengthen your Shoulder".
Intervention Type
Other
Intervention Name(s)
Strengthen your Shoulder
Intervention Description
A simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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".
Primary Outcome Measure Information:
Title
SPADI
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Abduction strength
Description
Maximum isometric voluntary contraction in shoulder abduction (continuous)
Time Frame
16 weeks
Title
External rotation strength
Description
Maximum isometric voluntary contraction in shoulder external rotation (continuous)
Time Frame
16 weeks
Title
Abduction ROM
Description
Active range of motion in shoulder abduction (continuous)
Time Frame
16 weeks
Title
Pain last week
Description
The average of least pain and average pain last week (continuous)
Time Frame
16 weeks
Title
QoL-index
Description
Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)
Time Frame
16 weeks
Title
QoL-index
Description
Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)
Time Frame
52 weeks
Title
QoL-VAS
Description
Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)
Time Frame
16 weeks
Title
QoL-VAS
Description
Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)
Time Frame
52 weeks
Title
PCS
Description
Pain Catastrophizing measured using the Pain Catastrophizing Scale (continuous)
Time Frame
16 weeks
Title
Temporal summation of pain (TS)
Description
The increase in pain recorded on an electronic VAS scale (range: 0-10 cm), during repeated standardized pressure induced pain stimuli (continuous)
Time Frame
16 weeks
Title
CPM-Threshold
Description
Conditioned pain threshold modulation, the percent increase in pressure pain tolerance threshold, when experimental tonic pain is induced (continuous)
Time Frame
16 weeks
Title
CPM-Detection
Description
Conditioned pain detection modulation, the percent increase in pressure pain detection threshold , when experimental tonic pain is induced (continuous)
Time Frame
16 weeks
Title
PPT-deltoid
Description
Pain pressure threshold at the deltoid muscle: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
Time Frame
16 weeks
Title
PPT-Supraspinatus
Description
Pain pressure threshold at the supraspinatus muscle: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
Time Frame
16 weeks
Title
PPT-Infraspinatus
Description
Pain pressure threshold at the infraspinatus muscle: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
Time Frame
16 weeks
Title
PPT-worst
Description
Pain pressure threshold at the site of worst pain: The pressure applied with a manual algometer when the sensation changes from a sensation of pressure to the first sensation of pain (continuous).
Time Frame
16 weeks
Title
Sick leave
Description
The number of days with reported sick leave due to shoulder disorder (continuous)
Time Frame
52 weeks
Title
Global impression of change
Description
Much improved or recovered? (Binary) Binary outcomes will be reported as proportions with corresponding 95% confidence intervals, and will be compared using a Chi-squared tests, and Odds Ratios computed from random effects logistic regression models.
Time Frame
16 weeks
Title
PASS
Description
Patient Acceptable Symptom State: Is the symptom state acceptable? (Binary)
Time Frame
16 weeks
Title
Surgery
Description
Surgery performed for the shoulder disorder? (Binary)
Time Frame
52 weeks
Title
SDT
Description
Scapula dyskinesia measured using the Scapula Dyskinesia Test (Binary)
Time Frame
16 weeks
Title
mSAT
Description
Scapula dysfunction measured using the modified Scapula Assistance Test (Binary)
Time Frame
16 weeks
Title
SPADI
Description
Shoulder Pain And Disability Index score (continuous)
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel B Clausen, PhD-Student
Organizational Affiliation
Bachelor's Degree Programme in Physiotherapy, Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, Metropolitan University College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Department, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34048281
Citation
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.
Results Reference
derived
PubMed Identifier
29499710
Citation
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.
Results Reference
derived

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Strengthening Exercises in Shoulder Impingement (SExSI) Trial

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