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Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Athletic Trainers’ Association Research & Education Foundation (NATA Foundation)
University of North Florida
Arcadia University
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00632996
First received: March 3, 2008
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Shoulder Impingement Syndrome
 Other: Rehabilitation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Rehabilitation for Subacromial Impingement Syndrome

Resource links provided by NLM:

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 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: Rehabilitation
Exercise, manual therapy, patient education, posture, home exercise program
Other Names:
  • Rehabilitation
  • Physical Therapy
  • Manual Therapy

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

Locations
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
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 by Virginia Commonwealth University

Additional 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
Study First Received: March 3, 2008
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013