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Exercise Training Sequence for Subacromial Impingement Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rotator Cuff Training
Scapular Training
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80 years of age
  • diagnosis of Neer Stage I/II subacromial impingement with a primary pain complaint in the shoulder and/or upper arm
  • presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (Hawkins-Kennedy or Neer/Walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation.

Exclusion Criteria:

  • concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis -
  • osteoarthritis greater than grade 2 on the Kellgren-Lawrence scale
  • current diagnosis and/or previous history of glenohumeral instability or dislocation
  • full-thickness rotator cuff tear
  • adhesive capsulitis
  • fractures of the scapula, clavicle or humerus
  • scapulothoracic or rotator cuff paresis
  • shoulder surgery in past year
  • inability to speak the English language at a level sufficient to obtain informed consent.

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Scapular Training

Rotator Cuff Training

Arm Description

Initiated scapular training exercise for the first 4 weeks followed by addition of rotator cuff exercises the next four weeks

initiated rotator cuff training exercise for the first 4 weeks followed by addition of scapular training exercises the next four weeks.

Outcomes

Primary Outcome Measures

American Shoulder Elbow Surgeon's Outcome Score
self-report of function
Numeric Pain Score
pain levels
Global Rating of Change
patient satisfaction
Global Percentage of Improvement
patient perception of status

Secondary Outcome Measures

Full Information

First Posted
June 16, 2015
Last Updated
May 14, 2016
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02478567
Brief Title
Exercise Training Sequence for Subacromial Impingement Syndrome
Official Title
The Effect of Axioscapular and Rotator Cuff Exercise Training Sequence in Patients With Subacromial Impingement Syndrome: A Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

5. Study Description

Brief Summary
Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.
Detailed Description
While physical therapy is an effective element in the rehabilitation of rotator cuff (RC) disease, the most effective sequence of training interventions has not been defined. The purpose of this study is to determine if there is a difference in pain or function in patients who are given RC strengthening prior to or after initiating scapular stabilization exercises. The study was a prospective randomized crossover design. 26 men and 14 women, mean age 51, diagnosed with subacromial impingement syndrome (SAIS) were randomly assigned to one of two groups for a comprehensive and standardized rehabilitation program over six visits at an orthopedic outpatient clinic. One group was prescribed a 4-week program of scapular stabilization exercises while the other group began with RC strengthening exercises. The crossover design had each group add the previously excluded four exercises to their second month of rehabilitation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scapular Training
Arm Type
Experimental
Arm Description
Initiated scapular training exercise for the first 4 weeks followed by addition of rotator cuff exercises the next four weeks
Arm Title
Rotator Cuff Training
Arm Type
Experimental
Arm Description
initiated rotator cuff training exercise for the first 4 weeks followed by addition of scapular training exercises the next four weeks.
Intervention Type
Other
Intervention Name(s)
Rotator Cuff Training
Other Intervention Name(s)
exercise
Intervention Description
four specific band-resisted strength training exercises for scapula
Intervention Type
Other
Intervention Name(s)
Scapular Training
Other Intervention Name(s)
exercise
Intervention Description
four specific band-resisted strength training exercises for rotator cuff
Primary Outcome Measure Information:
Title
American Shoulder Elbow Surgeon's Outcome Score
Description
self-report of function
Time Frame
16 weeks
Title
Numeric Pain Score
Description
pain levels
Time Frame
16 weeks
Title
Global Rating of Change
Description
patient satisfaction
Time Frame
16 weeks
Title
Global Percentage of Improvement
Description
patient perception of status
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years of age diagnosis of Neer Stage I/II subacromial impingement with a primary pain complaint in the shoulder and/or upper arm presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (Hawkins-Kennedy or Neer/Walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation. Exclusion Criteria: concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis - osteoarthritis greater than grade 2 on the Kellgren-Lawrence scale current diagnosis and/or previous history of glenohumeral instability or dislocation full-thickness rotator cuff tear adhesive capsulitis fractures of the scapula, clavicle or humerus scapulothoracic or rotator cuff paresis shoulder surgery in past year inability to speak the English language at a level sufficient to obtain informed consent.
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
76039
Country
United States

12. IPD Sharing Statement

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