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Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome

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ClinicalTrials.gov Identifier: NCT02153827
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Collaborator:
University of St. Augustine
Information provided by (Responsible Party):
Nova Southeastern University

Brief 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.

Condition or disease Intervention/treatment Phase
Subacromial Impingement Syndrome Other: Eccentric Shoulder External Rotator Training Other: General Shoulder exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shoulder External Rotator Eccentric Training for Subacromial Impingement Syndrome
Study Start Date : March 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eccentric External rotator training
Eccentric Shoulder External Rotators along with scapular retraction and posterior shoulder stretching exercises.
Other: Eccentric Shoulder External Rotator Training
Eccentric training exercise for the external rotators, 3 sets of 15 daily.

Sham Comparator: General shoulder exercise
General shoulder exercise protocol of active flexion, abduction, scapular retraction and posterior shoulder stretching exercises.
Other: General Shoulder exercise
general exercise consisting of active shoulder movements




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Global Rating of Change [ Time Frame: 6 months ]
    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.

  2. Numeric Pain Rating Scale [ Time Frame: 6 months ]
    0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.

  3. Shoulder Active Range of Motion [ Time Frame: 6 months ]
    Degrees of shoulder elevation with 0 being the least and 180 being the greatest.

  4. Upper Quarter Y Balance Test [ Time Frame: 6 months ]
    Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02153827


Locations
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United States, Florida
University of St. Augustine
St. Augustine, Florida, United States, 32086
Sponsors and Collaborators
Nova Southeastern University
University of St. Augustine
Investigators
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Study Chair: Morey Kolber, PhD, PT Nova Southeastern

Publications of Results:
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Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02153827     History of Changes
Other Study ID Numbers: 12111308exp
First Posted: June 3, 2014    Key Record Dates
Results First Posted: October 20, 2016
Last Update Posted: October 20, 2016
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nova Southeastern University:
Shoulder
Eccentric Training
Subacromial Impingement Syndrome
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases