Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

Shoulder Impingement Syndrome Clinical Trial

Official title:

Effectiveness of Rehabilitation for Subacromial Impingement Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632996
• Other study ID #: HM10320
• Secondary ID: Proposal #:PT101
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2008
• Last updated: December 18, 2015
• Start date: January 2008
• Est. completion date: January 2014

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

Other:
• Rehabilitation
Exercise, manual therapy, patient education, posture, home exercise program

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Arcadia University, National Athletic Trainers’ Association Research & Education Foundation (NATA Foundation), University of North Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder disability		6 week and 3, 6, 12 months	No
Secondary	Patient satisfaction		6 weeks and 3, 6, 12 months	No
Secondary	Quality of life		6 weeks and 3, 6, 12 months	Yes
Secondary	Pain with rest, normal activities, and strenuous activities		6 weeks and 3, 6, 12 months	No
Secondary	Patient perceived global rating of effect		6 weeks and 3 months	No
Secondary	Additional healthcare utilization and medication use		6 weeks and 3, 6, 12 months	No