Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome

August 26, 2016 updated by: Nova Southeastern University

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.

Study Overview

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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • St. Augustine, Florida, United States, 32086
        • University of St. Augustine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
general exercise consisting of active shoulder movements

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
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
Shoulder Active Range of Motion
Time Frame: 6 months
Degrees of shoulder elevation with 0 being the least and 180 being the greatest.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Morey Kolber, PhD, PT, Nova Southeastern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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