Subacromial Impingement SyndromeNCT02747251
Strengthening Exercises in Shoulder Impingement (SExSI) Trial
A study testing Strengthen your Shoulder in people with Subacromial Impingement Syndrome, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Strengthen your Shoulder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 13 May 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Additional Home-based Strengthening Exercises in Shoulder Impingement Rehabilitation (The SEXSI-Trial): A Pragmatic Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Strengthen your Shoulder, Usual Care
- Keywords
- "Shoulder Impingement Syndrome"[Mesh], "Rehabilitation"[Mesh], "Exercise"[Mesh], "Rotator Cuff"[Mesh]
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthen your ShoulderOther
A simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band.
Usual CareOther
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".
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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". Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (23)
Abduction strength
Maximum isometric voluntary contraction in shoulder abduction (continuous)
Measured: 16 weeks
External rotation strength
Maximum isometric voluntary contraction in shoulder external rotation (continuous)
Measured: 16 weeks
Abduction ROM
Active range of motion in shoulder abduction (continuous)
Measured: 16 weeks
Pain last week
The average of least pain and average pain last week (continuous)
Measured: 16 weeks
QoL-index
Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)
Measured: 16 weeks
QoL-index
Health related Quality of Life measured using the Danish EQ-5D-3L index (continuous)
Measured: 52 weeks
QoL-VAS
Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)
Measured: 16 weeks
QoL-VAS
Health related Quality of Life measured using the Danish EQ-5D-3L VAS (continuous)
Measured: 52 weeks
PCS
Pain Catastrophizing measured using the Pain Catastrophizing Scale (continuous)
Measured: 16 weeks
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)
Measured: 16 weeks
CPM-Threshold
Conditioned pain threshold modulation, the percent increase in pressure pain tolerance threshold, when experimental tonic pain is induced (continuous)
Measured: 16 weeks
CPM-Detection
Conditioned pain detection modulation, the percent increase in pressure pain detection threshold , when experimental tonic pain is induced (continuous)
Measured: 16 weeks
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).
Measured: 16 weeks
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).
Measured: 16 weeks
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).
Measured: 16 weeks
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).
Measured: 16 weeks
Sick leave
The number of days with reported sick leave due to shoulder disorder (continuous)
Measured: 52 weeks
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.
Measured: 16 weeks
PASS
Patient Acceptable Symptom State: Is the symptom state acceptable? (Binary)
Measured: 16 weeks
Surgery
Surgery performed for the shoulder disorder? (Binary)
Measured: 52 weeks
SDT
Scapula dyskinesia measured using the Scapula Dyskinesia Test (Binary)
Measured: 16 weeks
mSAT
Scapula dysfunction measured using the modified Scapula Assistance Test (Binary)
Measured: 16 weeks
SPADI
Shoulder Pain And Disability Index score (continuous)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start13 May 2016
- Primary completion29 Oct 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Metropolitan University College, University of Copenhagen, Aalborg University
- Responsible party
- Principal investigator, Mikkel Bek Clausen, Copenhagen University Hospital, Hvidovre
- Investigators
- Mikkel B Clausen, PhD-Student, Principal investigator, Bachelor's Degree Programme in Physiotherapy, Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, Metropolitan University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747251
- Sponsor's protocol ID
- H-16016763
- Status last verified
- Jan 2020
- First submitted
- 19 Apr 2016
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41140544Clausen 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.
PubMed 36898767Clausen 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.
PubMed 34048281Clausen 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.
PubMed 29499710
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Additional Home-based Strengthening Exercises in Shoulder Impingement Rehabilitation (The SEXSI-Trial): A Pragmatic Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02747251
- Acronym / sponsor ID
- H-16016763
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- "Shoulder Impingement Syndrome"[Mesh], "Rehabilitation"[Mesh], "Exercise"[Mesh], "Rotator Cuff"[Mesh]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Metropolitan University College, University of Copenhagen, Aalborg University
- Study start
- 13 May 2016 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthen your Shoulder & Usual Care | Experimental | Other: Strengthen your Shoulder, Other: Usual CareInstructions 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". |
| Usual Care | Active comparator | Other: Usual CareIncludes all treatment received by a patient during the time between baseline and follow-up, except that included in "Strengthen your Shoulder". |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthen your ShoulderA simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band. | Other | Strengthen your Shoulder & Usual Care |
| Usual CareUsual 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". | Other | Strengthen your Shoulder & Usual Care, Usual Care |
Primary outcome
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.
23 secondary outcomes
Abduction strength
Time frame: 16 weeks
External rotation strength
Time frame: 16 weeks
Abduction ROM
Time frame: 16 weeks
Pain last week
Time frame: 16 weeks
QoL-index
Time frame: 16 weeks
QoL-index
Time frame: 52 weeks
QoL-VAS
Time frame: 16 weeks
QoL-VAS
Time frame: 52 weeks
PCS
Time frame: 16 weeks
Temporal summation of pain (TS)
Time frame: 16 weeks
CPM-Threshold
Time frame: 16 weeks
CPM-Detection
Time frame: 16 weeks
PPT-deltoid
Time frame: 16 weeks
PPT-Supraspinatus
Time frame: 16 weeks
PPT-Infraspinatus
Time frame: 16 weeks
PPT-worst
Time frame: 16 weeks
Sick leave
Time frame: 52 weeks
Global impression of change
Time frame: 16 weeks
PASS
Time frame: 16 weeks
Surgery
Time frame: 52 weeks
SDT
Time frame: 16 weeks
mSAT
Time frame: 16 weeks
SPADI
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 41140544Clausen 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.
- Derived from this study: PubMed 36898767Clausen 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.
- Derived from this study: PubMed 34048281Clausen 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.
- Derived from this study: PubMed 29499710Clausen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel B Clausen, PhD-Student principal investigator
Bachelor's Degree Programme in Physiotherapy, Department of Physiotherapy and Occupational Therapy, Faculty of Health and Technology, Metropolitan University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthen your Shoulder in people with Subacromial Impingement Syndrome, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPADI (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747251, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.