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Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Proaxis Therapy.   Recruitment status was  Recruiting

First Received on March 4, 2008.   Last Updated on February 2, 2010   History of Changes
Sponsor: Proaxis Therapy
Collaborators: Virginia Commonwealth University
Arcadia University
National Athletic Training Association Research and Education Foundation
Information provided by: Proaxis Therapy
ClinicalTrials.gov Identifier: NCT00633451
  Purpose

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.


Condition Intervention
Shoulder Impingement Syndrome
 Other: Manual Therapy and Exercise
Other: Exercise Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only

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 Proaxis Therapy:

Primary Outcome Measures:
  • Shoulder disability and pain [ Time Frame: 6 weeks and 3, 6,12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Manual Therapy + Exercise
 Other: Manual Therapy and Exercise
Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.
Other Name: Manual Therapy and Therapeutic Exercise
Active Comparator: 2
Exercise Only
 Other: Exercise Only
A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
Other Name: Therapeutic Exercise

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633451

Contacts
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

Locations
United States, South Carolina
Proaxis Therapy Recruiting
Greenville, South Carolina, United States, 29607
Contact: Charles A Thigpen, PT, PhD, ATC     864-454-0904     chuck.thigpen@proaxistherapy.com    
Sponsors and Collaborators
Proaxis Therapy
Virginia Commonwealth University
Arcadia University
National Athletic Training Association Research and Education Foundation
Investigators
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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Charles A Thigpen, PT, PhD, ATC Clinical Research Scientist, Proaxis Therapy
ClinicalTrials.gov Identifier: NCT00633451     History of Changes
Other Study ID Numbers: 07-173
Study First Received: March 4, 2008
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Proaxis Therapy:
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 February 09, 2012



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