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: January 6, 2014
Last verified: January 2014

March 3, 2008
January 6, 2014
January 2008
January 2014   (final data collection date for primary outcome measure)
Shoulder disability [ Time Frame: 6 week and 3, 6, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00632996 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Shoulder Impingement Syndrome
Other: Rehabilitation
Exercise, manual therapy, patient education, posture, home exercise program
Other Names:
  • Rehabilitation
  • Physical Therapy
  • Manual Therapy
Experimental: 1
Intervention: Other: Rehabilitation
Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
225
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00632996
HM10320, Proposal #:PT101875
No
Virginia Commonwealth University
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
Virginia Commonwealth University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP