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Strengthening Exercises in Shoulder Impingement (SExSI) Trial

This study is currently recruiting participants.
Verified May 2017 by Mikkel Bek Clausen, Copenhagen University Hospital, Hvidovre
Sponsor:
ClinicalTrials.gov Identifier:
NCT02747251
First Posted: April 21, 2016
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Metropolitan University College
University of Copenhagen
Aalborg University
Information provided by (Responsible Party):
Mikkel Bek Clausen, Copenhagen University Hospital, Hvidovre
  Purpose
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.

Condition Intervention
Subacromial Impingement Syndrome Other: Strengthen your Shoulder Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Additional Home-based Strengthening Exercises in Shoulder Impingement Rehabilitation (The SEXSI-Trial): A Pragmatic Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Mikkel Bek Clausen, Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • SPADI [ Time Frame: 16 weeks ]

    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 [ Time Frame: 16 weeks ]
    Maximum isometric voluntary contraction in shoulder abduction (continuous)

  • External rotation strength [ Time Frame: 16 weeks ]
    Maximum isometric voluntary contraction in shoulder external rotation (continuous)

  • Abduction ROM [ Time Frame: 16 weeks ]
    Active range of motion in shoulder abduction (continuous)

  • Pain last week [ Time Frame: 16 weeks ]
    The average of least pain and average pain last week (continuous)

  • QoL-index [ Time Frame: 16 weeks ]
    Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)

  • QoL-index [ Time Frame: 52 weeks ]
    Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)

  • QoL-VAS [ Time Frame: 16 weeks ]
    Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)

  • QoL-VAS [ Time Frame: 52 weeks ]
    Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)

  • PCS [ Time Frame: 16 weeks ]
    Pain Catastrophizing measured using the Pain Catastrophizing Scale (continuous)

  • Temporal summation of pain (TS) [ Time Frame: 16 weeks ]
    The increase in pain recorded on an electronic VAS scale (range: 0-10 cm), during repeated standardized pressure induced pain stimuli (continuous)

  • CPM-Threshold [ Time Frame: 16 weeks ]
    Conditioned pain threshold modulation, the percent increase in pressure pain tolerance threshold, when experimental tonic pain is induced (continuous)

  • CPM-Detection [ Time Frame: 16 weeks ]
    Conditioned pain detection modulation, the percent increase in pressure pain detection threshold , when experimental tonic pain is induced (continuous)

  • PPT-deltoid [ Time Frame: 16 weeks ]
    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 [ Time Frame: 16 weeks ]
    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 [ Time Frame: 16 weeks ]
    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 [ Time Frame: 16 weeks ]
    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 [ Time Frame: 52 weeks ]
    The number of days with reported sick leave due to shoulder disorder (continuous)

  • Global impression of change [ Time Frame: 16 weeks ]
    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 [ Time Frame: 16 weeks ]
    Patient Acceptable Symptom State: Is the symptom state acceptable? (Binary)

  • Surgery [ Time Frame: 52 weeks ]
    Surgery performed for the shoulder disorder? (Binary)

  • SDT [ Time Frame: 16 weeks ]
    Scapula dyskinesia measured using the Scapula Dyskinesia Test (Binary)

  • mSAT [ Time Frame: 16 weeks ]
    Scapula dysfunction measured using the modified Scapula Assistance Test (Binary)

  • SPADI [ Time Frame: 52 weeks ]
    Shoulder Pain And Disability Index score (continuous)


Estimated Enrollment: 200
Actual Study Start Date: May 13, 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strengthen your Shoulder & Usual Care
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
A simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band.
Other: Usual Care
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".
Active Comparator: 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: Usual Care
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".

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747251


Contacts
Contact: Mikkel B Clausen, PhD-student +45 7248 9351 mibc@phmetropol.dk
Contact: Kristian Thorborg, PhD :+45 2627 1506 Kristian.thorborg@regionh.dk

Locations
Denmark
Orthopaedic Department, Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Mikkel B Clausen, PhD-Student    +45 28607580    mikkel.bek.clausen.01@regionh.dk   
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Metropolitan University College
University of Copenhagen
Aalborg University
Investigators
Principal Investigator: 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
  More Information

Responsible Party: Mikkel Bek Clausen, PhD-Student, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT02747251     History of Changes
Other Study ID Numbers: H-16016763
First Submitted: April 19, 2016
First Posted: April 21, 2016
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mikkel Bek Clausen, Copenhagen University Hospital, Hvidovre:
"Shoulder Impingement Syndrome"[Mesh]
"Rehabilitation"[Mesh]
"Exercise"[Mesh]
"Rotator Cuff"[Mesh]

Additional relevant MeSH terms:
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases