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Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eccentric Shoulder External Rotator Training
General Shoulder exercise
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Shoulder, Eccentric Training, Subacromial Impingement Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of St. Augustine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Eccentric External rotator training

General shoulder exercise

Arm Description

Eccentric Shoulder External Rotators along with scapular retraction and posterior shoulder stretching exercises.

General shoulder exercise protocol of active flexion, abduction, scapular retraction and posterior shoulder stretching exercises.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Shoulder Active Range of Motion
Degrees of shoulder elevation with 0 being the least and 180 being the greatest.
Upper Quarter Y Balance Test
Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.

Full Information

First Posted
March 31, 2014
Last Updated
August 26, 2016
Sponsor
Nova Southeastern University
Collaborators
University of St. Augustine
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1. Study Identification

Unique Protocol Identification Number
NCT02153827
Brief Title
Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome
Official Title
Shoulder External Rotator Eccentric Training for Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University
Collaborators
University of St. Augustine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Shoulder, Eccentric Training, Subacromial Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eccentric External rotator training
Arm Type
Experimental
Arm Description
Eccentric Shoulder External Rotators along with scapular retraction and posterior shoulder stretching exercises.
Arm Title
General shoulder exercise
Arm Type
Sham Comparator
Arm Description
General shoulder exercise protocol of active flexion, abduction, scapular retraction and posterior shoulder stretching exercises.
Intervention Type
Other
Intervention Name(s)
Eccentric Shoulder External Rotator Training
Intervention Description
Eccentric training exercise for the external rotators, 3 sets of 15 daily.
Intervention Type
Other
Intervention Name(s)
General Shoulder exercise
Intervention Description
general exercise consisting of active shoulder movements
Primary Outcome Measure Information:
Title
Change in Western Ontario Rotator Cuff Index
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Global Rating of Change
Description
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.
Time Frame
6 months
Title
Numeric Pain Rating Scale
Description
0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.
Time Frame
6 months
Title
Shoulder Active Range of Motion
Description
Degrees of shoulder elevation with 0 being the least and 180 being the greatest.
Time Frame
6 months
Title
Upper Quarter Y Balance Test
Description
Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morey Kolber, PhD, PT
Organizational Affiliation
Nova Southeastern
Official's Role
Study Chair
Facility Information:
Facility Name
University of St. Augustine
City
St. Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22349588
Citation
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.
Results Reference
result
PubMed Identifier
22441232
Citation
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.
Results Reference
result
PubMed Identifier
22581193
Citation
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.
Results Reference
result
PubMed Identifier
20713438
Citation
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.
Results Reference
result
PubMed Identifier
15877219
Citation
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.
Results Reference
result

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Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome

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