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Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

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ClinicalTrials.gov Identifier: NCT00632996
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : December 21, 2015
National Athletic Trainers’ Association Research & Education Foundation (NATA Foundation)
University of North Florida
Arcadia University
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Other: Rehabilitation Phase 2

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  (Clinical Trial)
Actual Enrollment : 162 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Rehabilitation for Subacromial Impingement Syndrome
Study Start Date : January 2008
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Shoulder disability [ Time Frame: 6 week and 3, 6, 12 months ]

Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 6 weeks and 3, 6, 12 months ]
  2. Quality of life [ Time Frame: 6 weeks and 3, 6, 12 months ]
  3. Pain with rest, normal activities, and strenuous activities [ Time Frame: 6 weeks and 3, 6, 12 months ]
  4. Patient perceived global rating of effect [ Time Frame: 6 weeks and 3 months ]
  5. Additional healthcare utilization and medication use [ Time Frame: 6 weeks and 3, 6, 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632996

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Athletic Trainers’ Association Research & Education Foundation (NATA Foundation)
University of North Florida
Arcadia University
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00632996     History of Changes
Other Study ID Numbers: HM10320
Proposal #:PT101875
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015

Keywords provided by Virginia Commonwealth University:
shoulder pain
shoulder impingement syndrome
manual therapy

Additional relevant MeSH terms:
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Pathologic Processes
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases