Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Other: Manual Therapy and Exercise; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Proaxis Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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.; Other Names: Manual Therapy and Therapeutic Exercise
Active Comparator: 2; Exercise Only	Other: Exercise Only; A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function; Other Names: Therapeutic Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Shoulder disability and pain	6 weeks and 3, 6,12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient perceived global rating of effect	6 weeks and 3 months
Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication	6 weeks, and 3, 6, 12 months

Collaborators and Investigators

• Sponsor: Proaxis Therapy
• Collaborators: Virginia Commonwealth University; Arcadia University; National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
• Investigators: Principal Investigator: Lori A Michener, PhD, PT, ATC, Virginia Commonwealth University; Study Director: Angela R Tate, PhD, PT, Arcadia University; Principal Investigator: Charles A Thigpen, PhD, PT, ATC, University of North Florida; Principal Investigator: Phil McClure, PhD, PT, Arcadia University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 4, 2008
• First Submitted That Met QC Criteria: March 4, 2008
• First Posted (Estimate): March 12, 2008

Study Record Updates

• Last Update Posted (Estimate): March 28, 2013
• Last Update Submitted That Met QC Criteria: March 26, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: rehabilitation; manual therapy; shoulder pain; shoulder impingement syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: 07-173