Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome - Full Text View

Sponsors and Collaborators:	Virginia Commonwealth University National Athletic Trainers' Association REF University of North Florida Arcadia University
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00632996

Purpose

The purposes of this study are to:

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;
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:

the rehabilitation treatment program will result in significant changes in pain and quality of life
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.

Condition	Intervention	Phase
Shoulder Impingement Syndrome	Other: Rehabilitation	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Effectiveness of Rehabilitation for Subacromial Impingement Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation Shoulder Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Shoulder disability [ Time Frame: 6 week and 3, 6, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient satisfaction [ Time Frame: 6 weeks and 3, 6, 12 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 6 weeks and 3, 6, 12 months ] [ Designated as safety issue: Yes ]
Pain with rest, normal activities, and strenuous activities [ Time Frame: 6 weeks and 3, 6, 12 months ] [ Designated as safety issue: No ]
Patient perceived global rating of effect [ Time Frame: 6 weeks and 3 months ] [ Designated as safety issue: No ]
Additional healthcare utilization and medication use [ Time Frame: 6 weeks and 3, 6, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	225
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Other: Rehabilitation Exercise, manual therapy, patient education, posture, home exercise program

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632996

Contacts

Contact: Lori Michener, PhD, PT, ATC	804-828-0234	lamichen@vcu.edu
Contact: Angela Tate, PhD, PT	215-572-2865	tatea@arcadia.edu

Locations

United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Lori A Michener, PhD, PT, ATC

Sponsors and Collaborators

Virginia Commonwealth University

National Athletic Trainers' Association REF

University of North Florida

Arcadia University

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

More Information

No publications provided

Responsible Party:	Virginia Commonwealth University ( Lori Michener, PhD, PT, ATC )
Study ID Numbers:	HM10320, Proposal #:PT101875
Study First Received:	March 3, 2008
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00632996 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

shoulder pain
shoulder impingement syndrome
manual therapy
rehabilitation

Study placed in the following topic categories:

Musculoskeletal Diseases
Shoulder Pain
Joint Diseases
Pain
Shoulder Impingement Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Musculoskeletal Diseases

Joint Diseases
Syndrome
Shoulder Impingement Syndrome

ClinicalTrials.gov processed this record on September 10, 2009