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Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy and Exercise
Exercise Only
Sponsored by
Proaxis Therapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Proaxis Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Manual Therapy + Exercise

Exercise Only

Outcomes

Primary Outcome Measures

Shoulder disability and pain

Secondary Outcome Measures

Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication
Patient perceived global rating of effect

Full Information

First Posted
March 4, 2008
Last Updated
March 26, 2013
Sponsor
Proaxis Therapy
Collaborators
Virginia Commonwealth University, Arcadia University, National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
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1. Study Identification

Unique Protocol Identification Number
NCT00633451
Brief Title
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
Official Title
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Proaxis Therapy
Collaborators
Virginia Commonwealth University, Arcadia University, National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Manual Therapy + Exercise
Arm Title
2
Arm Type
Active Comparator
Arm Description
Exercise Only
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Exercise
Other Intervention Name(s)
Manual Therapy and Therapeutic Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Only
Other Intervention Name(s)
Therapeutic Exercise
Intervention Description
A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
Primary Outcome Measure Information:
Title
Shoulder disability and pain
Time Frame
6 weeks and 3, 6,12 months
Secondary Outcome Measure Information:
Title
Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication
Time Frame
6 weeks, and 3, 6, 12 months
Title
Patient perceived global rating of effect
Time Frame
6 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms associated with athletic activity (35% of patients) Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria: Reproduction of symptoms with impingement test: either Hawkins- Kennedy or Neer Test Pain during active shoulder elevation at or above 60 degrees 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: Markedly reduced shoulder external rotation strength Drop arm test External rotation lag sign Lift off test Positive findings on MRI or ultrasonography
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles A Thigpen, PhD, PT, ATC
Organizational Affiliation
University of North Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lori A Michener, PhD, PT, ATC
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phil McClure, PhD, PT
Organizational Affiliation
Arcadia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela R Tate, PhD, PT
Organizational Affiliation
Arcadia University
Official's Role
Study Director
Facility Information:
Facility Name
Proaxis Therapy
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.proaxistherapy.com
Description
Related Info

Learn more about this trial

Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

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