Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

NCT ID: NCT00632996

Last Updated: 2015-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2014-01-31

Brief 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.

Detailed 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.

Conditions

Shoulder Impingement Syndrome

Keywords

shoulder pain; shoulder impingement syndrome; manual therapy; rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

Exercise, manual therapy, patient education, posture, home exercise program

Interventions

Rehabilitation

Exercise, manual therapy, patient education, posture, home exercise program

Intervention Type: OTHER

Other Intervention Names

Physical Therapy; Manual Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)

OTHER

Sponsor Role: collaborator

University of North Florida

OTHER

Sponsor Role: collaborator

Arcadia University

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori A Michener, PhD, PT, ATC

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Phillip W McClure, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Arcadia University

Angela R Tate, PhD, PT

Role: STUDY_DIRECTOR

Arcadia University

Ian A Young, PT

Role: STUDY_CHAIR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2519/jospt.2010.3223.

Reference Type: DERIVED

PMID: 20710088 (View on PubMed)

Other Identifiers

Proposal #:PT101875

Identifier Type: -

Identifier Source: secondary_id

HM10320

Identifier Type: -

Identifier Source: org_study_id