Subacromial Impingement SyndromeNCT02153827
Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome
A study testing Eccentric Shoulder External Rotator Training and General Shoulder exercise in people with Subacromial Impingement Syndrome, run by Nova Southeastern University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of eccentric exercise to the shoulder muscles for people with shoulder pain. Identifying specific exercise protocols for individuals with shoulder pain will provide evidence to help clinicians select the best interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Eccentric Shoulder External Rotator Training and General Shoulder exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of non-acute shoulder pain (greater than 3 months duration)
- 3 out of the 6 following tests positive, Neer impingement, Hawkins-Kennedy impingement, empty can test, resisted external rotation test, palpable tenderness at the insertion of the supraspinatus or infraspinatus, and painful arc from 60° to 120° during active abduction.
- Age over 18 years old
- Sufficient ability to read English as required for completing questionnaires
Who cannot join
- Red flags noted in the patient's Medical Screening Questionnaire (MSQ) (ie. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use)
- Full thickness supraspinatus or infraspinatus tendon tear as determined by a positive drop arm test, lag sign or rent test.
- Shoulder adhesive capsulitis as evidenced by a limitation in passive motion for all shoulder planes of movement.
- Having an upper extremity amputation.
- Individuals having a history of surgery to the cervical spine or involved upper extremity for a musculoskeletal, neurological or dermatological condition for which they are at the time of data collection receiving post-operative care.
- Pending legal action regarding their shoulder pain
- Inability to comply with treatment and follow up schedule
- Insufficient English language skills to complete all questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
University of St. Augustine
Saint Augustine, Florida, 32086
About this study
Official title: Shoulder External Rotator Eccentric Training for Subacromial Impingement Syndrome
The purpose of this study is to examine the effects of eccentric exercise to the shoulder muscles for people with shoulder pain. Identifying specific exercise protocols for individuals with shoulder pain will provide evidence to help clinicians select the best interventions.
Read the detailed description
Prior investigations for eccentric training of the shoulder have primarily utilized a pain provocation model for exercise progression. This method of progressing resistance training load and volume assumes that pain must be increased during the exercise movement for clinical benefit to occur. When the individual reports a reduction in pain, load is increased so that the provoking pain level returns. The contrast to this approach would be a performance based progression as utilized in the Blume et al study for shoulder eccentric training. This method progresses a patient based on ability to perform a higher number of repetitions at a given load without increasing symptoms which could be favorable in many clinical settings.
Further investigation on the role of eccentric training, specifically to the shoulder external rotators, in patients with SAPS is warranted. Thus, the aim of this investigation was to compare outcomes, for individuals diagnosed with SAPS, performing a six week protocol of eccentric training to the shoulder external rotators compared to a general exercise protocol.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Eccentric Shoulder External Rotator Training, General Shoulder exercise
- Keywords
- Shoulder, Eccentric Training, Subacromial Impingement Syndrome
- 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.
Eccentric Shoulder External Rotator TrainingOther
Eccentric training exercise for the external rotators, 3 sets of 15 daily.
General Shoulder exerciseOther
general exercise consisting of active shoulder movements
| Study group | Role | What they receive |
|---|---|---|
| Eccentric External rotator training | Experimental | Eccentric Shoulder External Rotators along with scapular retraction and posterior shoulder stretching exercises. Receives: Other: Eccentric Shoulder External Rotator Training |
| General shoulder exercise | Sham comparator | General shoulder exercise protocol of active flexion, abduction, scapular retraction and posterior shoulder stretching exercises. Receives: Other: General Shoulder exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario Rotator Cuff Index
shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.
Measured: 6 months
Secondary outcomes (4)
Global Rating of Change
Global rating of change is a single item questionnaire asking about total change since beginning treatment. The scale ranges from -7 (a great deal worse) to +7 (a great deal better). The unit of measure is scores on a scale.
Measured: 6 months
Numeric Pain Rating Scale
0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.
Measured: 6 months
Shoulder Active Range of Motion
Degrees of shoulder elevation with 0 being the least and 180 being the greatest.
Measured: 6 months
Upper Quarter Y Balance Test
Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of St. Augustine
- Responsible party
- Sponsor
- Investigators
- Morey Kolber, PhD, PT, Study chair, Nova Southeastern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153827
- Sponsor's protocol ID
- 12111308exp
- Status last verified
- Apr 2015
- First submitted
- 31 Mar 2014
- Last updated
- 20 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
PubMed 22349588Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012 Jan-Feb;16(1):74-83. doi: 10.1590/s1413-35552012000100013.
PubMed 22441232Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.
PubMed 22581193Bernhardsson S, Klintberg IH, Wendt GK. Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome. Clin Rehabil. 2011 Jan;25(1):69-78. doi: 10.1177/0269215510376005. Epub 2010 Aug 16.
PubMed 20713438Jonsson P, Wahlstrom P, Ohberg L, Alfredson H. Eccentric training in chronic painful impingement syndrome of the shoulder: results of a pilot study. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):76-81. doi: 10.1007/s00167-004-0611-8. Epub 2005 May 5.
PubMed 15877219
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder External Rotator Eccentric Training for Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT02153827
- Acronym / sponsor ID
- 12111308exp
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Shoulder, Eccentric Training, Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- University of St. Augustine
- Study start
- Mar 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 20 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of eccentric exercise to the shoulder muscles for people with shoulder pain. Identifying specific exercise protocols for individuals with shoulder pain will provide evidence to help clinicians select the best interventions.
Detailed description
Prior investigations for eccentric training of the shoulder have primarily utilized a pain provocation model for exercise progression. This method of progressing resistance training load and volume assumes that pain must be increased during the exercise movement for clinical benefit to occur. When the individual reports a reduction in pain, load is increased so that the provoking pain level returns. The contrast to this approach would be a performance based progression as utilized in the Blume et al study for shoulder eccentric training. This method progresses a patient based on ability to perform a higher number of repetitions at a given load without increasing symptoms which could be favorable in many clinical settings.
Further investigation on the role of eccentric training, specifically to the shoulder external rotators, in patients with SAPS is warranted. Thus, the aim of this investigation was to compare outcomes, for individuals diagnosed with SAPS, performing a six week protocol of eccentric training to the shoulder external rotators compared to a general exercise protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric External rotator training | Experimental | Other: Eccentric Shoulder External Rotator TrainingEccentric Shoulder External Rotators along with scapular retraction and posterior shoulder stretching exercises. |
| General shoulder exercise | Sham comparator | Other: General Shoulder exerciseGeneral shoulder exercise protocol of active flexion, abduction, scapular retraction and posterior shoulder stretching exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of non-acute shoulder pain (greater than 3 months duration)
- 3 out of the 6 following tests positive, Neer impingement, Hawkins-Kennedy impingement, empty can test, resisted external rotation test, palpable tenderness at the insertion of the supraspinatus or infraspinatus, and painful arc from 60° to 120° during active abduction.
- Age over 18 years old
- Sufficient ability to read English as required for completing questionnaires
Key exclusion criteria (8 listed)
- Red flags noted in the patient's Medical Screening Questionnaire (MSQ) (ie. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use)
- Full thickness supraspinatus or infraspinatus tendon tear as determined by a positive drop arm test, lag sign or rent test.
- Shoulder adhesive capsulitis as evidenced by a limitation in passive motion for all shoulder planes of movement.
- Having an upper extremity amputation.
- Individuals having a history of surgery to the cervical spine or involved upper extremity for a musculoskeletal, neurological or dermatological condition for which they are at the time of data collection receiving post-operative care.
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 |
|---|---|---|
| Eccentric Shoulder External Rotator TrainingEccentric training exercise for the external rotators, 3 sets of 15 daily. | Other | Eccentric External rotator training |
| General Shoulder exercisegeneral exercise consisting of active shoulder movements | Other | General shoulder exercise |
Primary outcome
Change in Western Ontario Rotator Cuff Index
Time frame: 6 months
shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.
4 secondary outcomes
Global Rating of Change
Time frame: 6 months
Numeric Pain Rating Scale
Time frame: 6 months
Shoulder Active Range of Motion
Time frame: 6 months
Upper Quarter Y Balance Test
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22349588Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
- Results publication: PubMed 22441232Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012 Jan-Feb;16(1):74-83. doi: 10.1590/s1413-35552012000100013.
- Results publication: PubMed 22581193Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.
- Results publication: PubMed 20713438Bernhardsson S, Klintberg IH, Wendt GK. Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome. Clin Rehabil. 2011 Jan;25(1):69-78. doi: 10.1177/0269215510376005. Epub 2010 Aug 16.
- Results publication: PubMed 15877219Jonsson P, Wahlstrom P, Ohberg L, Alfredson H. Eccentric training in chronic painful impingement syndrome of the shoulder: results of a pilot study. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):76-81. doi: 10.1007/s00167-004-0611-8. Epub 2005 May 5.
- Individual participant dataSharing planned: No
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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.
Morey Kolber, PhD, PT study chair
Nova Southeastern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric Shoulder External Rotator Training and General Shoulder exercise in people with Subacromial Impingement Syndrome, run by Nova Southeastern University at 1 site in United States.
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 4 inclusion and 8 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 20 Oct 2016. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Western Ontario Rotator Cuff Index (time frame: 6 months). 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 NCT02153827, which also lists 5 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 20 Oct 2016.