Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

Phase 2

Completed

• Conditions: Shoulder Impingement Syndrome
• Interventions: Other: Rehabilitation

• Registration Number: NCT00632996
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-18
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Shoulder disability	6 week and 3, 6, 12 months

Secondary Outcome Measures

Name	Time	Method
Pain with rest, normal activities, and strenuous activities	6 weeks and 3, 6, 12 months
Additional healthcare utilization and medication use	6 weeks and 3, 6, 12 months
Quality of life	6 weeks and 3, 6, 12 months
Patient satisfaction	6 weeks and 3, 6, 12 months
Patient perceived global rating of effect	6 weeks and 3 months

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States