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Comparison of Exercise Interventions in Adults With Subacromial Impingement Syndrome

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoulder resistive exercise
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring subacromial, rotator cuff, impingement, physical therapy, eccentric exercise, concentric exercise

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age and older
  • Present with clinical signs of subacromial impingement syndrome
  • Have not yet initiated physical or occupational therapy treatment

Exclusion Criteria:

  • Previous shoulder, cervical, or thoracic surgery.
  • History of shoulder fracture, dislocation, labral tear, or full thickness rotator cuff tear
  • Treatment for neoplasm in the last year
  • Rheumatic disease
  • Adhesive capsulitis
  • Shoulder pain currently rated greater than or equal to 8/10 on the NPRS
  • Cardiac, neurological, or musculoskeletal condition that precludes ability to perform upper extremity resisted exercise
  • Pregnancy
  • inability to understand spoken or written English
  • Inability to arrange transport to evaluation or treatment sessions or not planning to stay in the area long enough to complete study

Sites / Locations

  • Texas Health Resources, Presbyterian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Concentric exercise group

Eccentric exercise group

Arm Description

The participants in this group will perform the intervention exercises by actively completing the lifting portion of the resistive shoulder exercises. The physical therapist will then perform the lowering portion of the exercise for the participant.

The participants in this group will actively perform the lowering portion of the resistive shoulder exercises in the intervention. The physical therapist will perform the lifting portion of the exercise for the participant.

Outcomes

Primary Outcome Measures

Change in Shoulder function
Measured by change in numeric pain rating scale (NPRS)score for shoulder pain, change in disabilities of the arm, shoulder, and hand (DASH) self-report of function score, change in shoulder abduction and external rotation strength assessed with a hand-held dynamometer, and change in shoulder flexion and scapular plane elevation pain-free range of motion assessed with a digital inclinometer.

Secondary Outcome Measures

Intratester reliability
A subset of participants will be tested for strength and range of motion outcomes twice at each time frame by the same examiner in order to analyze intratester reliability of the testing protocols using Intraclass Correlation Coefficients.

Full Information

First Posted
January 4, 2012
Last Updated
April 15, 2014
Sponsor
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT01508715
Brief Title
Comparison of Exercise Interventions in Adults With Subacromial Impingement Syndrome
Official Title
Comparison of an Eccentric Exercise Intervention to a Concentric Exercise Intervention in Adults With Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Woman's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare two different physical therapy exercise programs in persons who have shoulder pain in order to determine if they have a different affect on pain level and ability to use the injured shoulder after treatment. Both exercise groups will attend physical therapy for an hour,two to three times a week, for eight weeks. The first two weeks of therapy sessions will involve learning the exercises and testing to determine what weight to use during exercises. One group will perform a traditional therapy exercise program for shoulders using hand weights. The other group will perform a version of the same shoulder exercises but with a different exercise technique. Exercises in both programs are part of the standard of care for shoulder impingement in physical therapy but one program concentrates on the lowering portion of the exercise (eccentrics) while the other emphasizes the lifting portion of the exercise (concentrics). Both groups will perform the same warm-up, stretching, and cool-down exercises. Participants will also be required to perform a daily home exercise program of stretches and range of motion that will take about 20 minutes to complete. Exercise testing will determine the hand weight resistance used by each person during their therapy sessions and re-testing will occur every two weeks to determine any changes in the weight used for the exercises to keep them challenging. Pain level, ability to use the injured arm for daily activities, strength, and amount of movement in the shoulder, will be measured at the start of physical therapy and after five and eight weeks (end of study) of the exercise treatments. A concurrent study investigating the reliability of the shoulder motion and strength measurements used in the larger study will also be performed. Research hypotheses: Adults with shoulder pain who complete the eccentric progressive resistive exercise intervention will demonstrate significantly greater improvements in the outcome measures at three weeks, earlier in the intervention, than the concentric progressive resistive exercise intervention group. Adults with shoulder pain who perform progressive resistive exercise interventions, regardless of contraction type, will demonstrate significant improvement in the shoulder outcome measures at three and six weeks of intervention.
Detailed Description
This study will be a prospective, repeated-measure, randomized clinical trial comparing shoulder outcome measures in adults with SAIS following eccentric or concentric progressive resistance exercise intervention programs. Subjects: 36 persons with SAIS, aged 18 and older, will be recruited from the Texas Health Resources Dallas outpatient rehabilitation department and referring physicians. Procedures: Participants will be randomly assigned to either a concentric or eccentric intervention group. Participants will complete outcome measures for pain intensity, shoulder function, shoulder pain-free active range of motion (AROM) of flexion and scapular plane elevation, and shoulder pain-free strength of external rotation and abduction. Outcomes will be assessed by an investigator blinded to group assignment at baseline and after three and six weeks of intervention. Interventions will consist of supervised exercise sessions three times a week. Exercise progression will follow a standardized and systematic approach. The reliability of the AROM and strength outcome measures will be assessed concurrently using a random subset of six participants from each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
subacromial, rotator cuff, impingement, physical therapy, eccentric exercise, concentric exercise

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Concentric exercise group
Arm Type
Active Comparator
Arm Description
The participants in this group will perform the intervention exercises by actively completing the lifting portion of the resistive shoulder exercises. The physical therapist will then perform the lowering portion of the exercise for the participant.
Arm Title
Eccentric exercise group
Arm Type
Experimental
Arm Description
The participants in this group will actively perform the lowering portion of the resistive shoulder exercises in the intervention. The physical therapist will perform the lifting portion of the exercise for the participant.
Intervention Type
Other
Intervention Name(s)
Shoulder resistive exercise
Intervention Description
Both groups will perform the seated "full can", sidelying internal rotation (IR), sidelying external rotation (ER) with towel roll, supine protraction at 120° of flexion, sidelying horizontal abduction, sidelying abduction, and seated pulley extension using resistance weights in the participant's pain-free shoulder motion. One group will complete only the eccentric portion of the exercise actively, the other will complete only the concentric portion actively. The treating physical therapist will reposition the weights to avoid active resistance occuring in the opposite direction of the desired intervention. Both groups will use 70% of their predicted one repetition maximum (1RM), progressing to 80% with 1RM reassessed and training weight adjusted every two weeks.
Primary Outcome Measure Information:
Title
Change in Shoulder function
Description
Measured by change in numeric pain rating scale (NPRS)score for shoulder pain, change in disabilities of the arm, shoulder, and hand (DASH) self-report of function score, change in shoulder abduction and external rotation strength assessed with a hand-held dynamometer, and change in shoulder flexion and scapular plane elevation pain-free range of motion assessed with a digital inclinometer.
Time Frame
baseline, after 3 weeks and 6 weeks of intervention
Secondary Outcome Measure Information:
Title
Intratester reliability
Description
A subset of participants will be tested for strength and range of motion outcomes twice at each time frame by the same examiner in order to analyze intratester reliability of the testing protocols using Intraclass Correlation Coefficients.
Time Frame
over course of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and older Present with clinical signs of subacromial impingement syndrome Have not yet initiated physical or occupational therapy treatment Exclusion Criteria: Previous shoulder, cervical, or thoracic surgery. History of shoulder fracture, dislocation, labral tear, or full thickness rotator cuff tear Treatment for neoplasm in the last year Rheumatic disease Adhesive capsulitis Shoulder pain currently rated greater than or equal to 8/10 on the NPRS Cardiac, neurological, or musculoskeletal condition that precludes ability to perform upper extremity resisted exercise Pregnancy inability to understand spoken or written English Inability to arrange transport to evaluation or treatment sessions or not planning to stay in the area long enough to complete study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiana L Blume, PT, PhD, OCS
Organizational Affiliation
Texas Woman's University, Texas Health Resources, Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Health Resources, Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

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Comparison of Exercise Interventions in Adults With Subacromial Impingement Syndrome

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