- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02153827
Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome
Shoulder External Rotator Eccentric Training for Subacromial Impingement Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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St. Augustine, Florida, United States, 32086
- University of St. Augustine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eccentric External rotator training
Eccentric Shoulder External Rotators along with scapular retraction and posterior shoulder stretching exercises.
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Eccentric training exercise for the external rotators, 3 sets of 15 daily.
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Sham Comparator: General shoulder exercise
General shoulder exercise protocol of active flexion, abduction, scapular retraction and posterior shoulder stretching exercises.
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general exercise consisting of active shoulder movements
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Western Ontario Rotator Cuff Index
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Rating of Change
Time Frame: 6 months
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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.
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6 months
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Numeric Pain Rating Scale
Time Frame: 6 months
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0-10 pain scale with 0 meaning no pain and 10 being maximal pain.
This is derived from a single item questionnaire.
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6 months
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Shoulder Active Range of Motion
Time Frame: 6 months
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Degrees of shoulder elevation with 0 being the least and 180 being the greatest.
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6 months
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Upper Quarter Y Balance Test
Time Frame: 6 months
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Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Morey Kolber, PhD, PT, Nova Southeastern
Publications and helpful links
General 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.
- Camargo 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.
- Maenhout 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.
- Bernhardsson 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.
- Jonsson 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12111308exp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sevgi Medical CenterCompletedSubacromial Impingement Syndrome | Subacromial ImpingementTurkey
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Universidad Autonoma de Nuevo LeonCompletedSubacromial Impingement Syndrome | Rotator Cuff Impingement Syndrome | Subacromial BursitisMexico
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CHU de ReimsTerminatedSubacromial Impingement of the ShoulderFrance
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