Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome - Full Text View

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:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Efficacy Study
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:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator Exercise Only	Other: Exercise Only A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function

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:	Proaxis Therapy ( Charles A Thigpen, PT, PhD, ATC Clinical Research Scientist )
Study ID Numbers:	07-173
Study First Received:	March 4, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00633451 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Proaxis Therapy:

shoulder pain
shoulder impingement syndrome
manual therapy
rehabilitation

Additional relevant MeSH terms:

Pathologic Processes
Disease
Musculoskeletal Diseases

Joint Diseases
Syndrome
Shoulder Impingement Syndrome

ClinicalTrials.gov processed this record on November 20, 2009