Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

December 18, 2015 updated by: Virginia Commonwealth University

Effectiveness of Rehabilitation for Subacromial Impingement Syndrome

The purposes of this study are to:

  1. determine if a rehabilitation program that consists of exercise and manual therapy reduces pain and improves quality of life in patients with shoulder subacromial impingement syndrome;
  2. determine which patients are likely to respond to this rehabilitation program and which patients are not likely to respond to this rehabilitation program

The hypotheses are:

  1. the rehabilitation treatment program will result in significant changes in pain and quality of life
  2. there will be items from the history and examination that will identify those patients who respond favorably and those who do not respond favorably to rehabilitation at 6 weeks, 3, 6 and 12 months.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Subacromial impingement syndrome (SAIS) is the most frequent cause of shoulder pain. A variety of non-surgical treatments have been advocated to correct the impairments associated with SAIS. Clinical trials support the use of therapeutic exercise and joint mobilizations to improve pain and functional disability associated with SAIS. However, not all patients in these trials had a favorable outcome. Moreover, the effect sizes in these trials were small to moderate. Thus the purposes of this study are to 1. determine the effect of a multi-modal rehabilitation program consisting of strengthening, stretching, manual therapy to the shoulder and spine, patient education, posture, and functional re-training; and 2. identify those patients who are and who are not likely to respond to rehabilitation at the start of care.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

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

    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of shoulder impingement syndrome as evidence by all 5 criteria:

    1. Reproduction of symptoms with impingement test: either Hawkins-Kennedy or Neer Test
    2. Pain during active shoulder elevation at or above 60 degrees
    3. Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation
    4. Shoulder disability: greater than or equal to 20/100 (0 = no disability)
    5. Able to understand written and spoken English

Exclusion Criteria:

  • Severe pain; pain is > or equal to 7/10 on NPRS (0 = no pain)
  • Shoulder surgery on affected shoulder
  • Traumatic shoulder dislocation within the past 3 months
  • Previous rehabilitation for this episode of shoulder pain
  • Reproduction of shoulder pain with active or passive cervical motion
  • Systemic inflammatory joint disease
  • Global loss of passive shoulder ROM, indicative of adhesive capsulitis

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Exercise, manual therapy, patient education, posture, home exercise program
Other Names:
  • Manual Therapy
  • Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shoulder disability
Time Frame: 6 week and 3, 6, 12 months
6 week and 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: 6 weeks and 3, 6, 12 months
6 weeks and 3, 6, 12 months
Quality of life
Time Frame: 6 weeks and 3, 6, 12 months
6 weeks and 3, 6, 12 months
Pain with rest, normal activities, and strenuous activities
Time Frame: 6 weeks and 3, 6, 12 months
6 weeks and 3, 6, 12 months
Patient perceived global rating of effect
Time Frame: 6 weeks and 3 months
6 weeks and 3 months
Additional healthcare utilization and medication use
Time Frame: 6 weeks and 3, 6, 12 months
6 weeks and 3, 6, 12 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Lori A Michener, PhD, PT, ATC, Virginia Commonwealth University
  • Principal Investigator: Phillip W McClure, PhD, PT, Arcadia University
  • Study Director: Angela R Tate, PhD, PT, Arcadia University
  • Study Chair: Ian A Young, PT, Virginia Commonwealth University

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

January 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

December 18, 2015

Last Verified

December 1, 2015

More Information

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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