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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02478567
Other study ID # 052012-017
Secondary ID
Status Completed
Phase N/A
First received June 16, 2015
Last updated June 17, 2015
Start date August 2012
Est. completion date January 2015

Study information

Verified date June 2015
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2015
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Other:
Rotator Cuff Training
four specific band-resisted strength training exercises for scapula
Scapular Training
four specific band-resisted strength training exercises for rotator cuff

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary American Shoulder Elbow Surgeon's Outcome Score self-report of function 16 weeks No
Primary Numeric Pain Score pain levels 16 weeks No
Primary Global Rating of Change patient satisfaction 16 weeks No
Primary Global Percentage of Improvement patient perception of status 16 weeks No
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