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Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
This study is currently recruiting participants.
Study NCT00633451   Information provided by Proaxis Therapy
First Received: March 4, 2008   Last Updated: February 17, 2009   History of Changes

March 4, 2008
February 17, 2009
February 2008
January 2010   (final data collection date for primary outcome measure)
Shoulder disability and pain [ Time Frame: 6 weeks and 3, 6,12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00633451 on ClinicalTrials.gov Archive Site
  • Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication [ 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 ]
Same as current
 
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only

The purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. We hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.

Subacromial impingement syndrome (SAIS) is a frequent cause of shoulder pain. Clinical trials investigating the effectiveness of manual therapy have demonstrated improvements in outcomes when manual therapy has been added to a program of therapeutic exercise. However, the these clinical trials (3) have significant limitations and generalizability. Two of the three 3 trials had a small number of subjects (14 & 22 subjects) and all 3 trials had only short term follow up (<12 weeks) and used non-validated self report outcome measures. These limitations reduce the confidence with which clinicians can apply these results to the patients they treat with SAIS. Clear evidence is needed to justify the cost and clinician time required to perform manual therapy in the delivery of patient care. Therefore, the purpose of this randomized clinical trial is to examine the short-term and long-term effectiveness of manual therapy in addition to therapeutic exercise as compared to therapeutic exercise only in patients diagnosed with SAIS.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study
Shoulder Impingement Syndrome
  • Other: Manual Therapy and Exercise
  • Other: Exercise Only
  • Experimental: Manual Therapy + Exercise
  • Active Comparator: Exercise Only
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
January 2011
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptoms associated with athletic activity (35% of patients)
  • Diagnosis of shoulder impingement syndrome as evidence by all 3 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
  • Shoulder disability: 25/100 (0 = no disability)
  • Able to understand written and spoken

Exclusion Criteria:

  • Severe pain; pain is > 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
  • Full-thickness rotator cuff tear, as evidenced by any one of the following:

    1. Markedly reduced shoulder external rotation strength
    2. Drop arm test
    3. External rotation lag sign
    4. Lift off test
    5. Positive findings on MRI or ultrasonography
Both
18 Years to 75 Years
No
Contact: Charles A Thigpen, PT, PhD, ATC 864-454-0904 chuck.thigpen@proaxistherapy.com
Contact: Lori A Michener, PT, PhD, ATC 804-828-0234 lamichen@vcu.edu
United States
 
NCT00633451
Charles A Thigpen, PT, PhD, ATC Clinical Research Scientist, Proaxis Therapy
07-173
Proaxis Therapy
  • Virginia Commonwealth University
  • Arcadia University
  • National Athletic Training Association Research and Education Foundation
Principal Investigator: Charles A Thigpen, PhD, PT, ATC University of North Florida
Principal Investigator: Lori A Michener, PhD, PT, ATC Virginia Commonwealth University
Principal Investigator: Phil McClure, PhD, PT Arcadia University
Study Director: Angela R Tate, PhD, PT Arcadia University
Proaxis Therapy
February 2009

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