Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Puget Sound
Franklin Pierce University
Information provided by (Responsible Party):
Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT01190891
First received: June 9, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate and compare the short and long-term effectiveness of two common interventions, manual physical therapy versus corticosteroid injection, for the treatment of shoulder impingement syndrome.


Condition Intervention
Shoulder Impingement Syndrome
Procedure: Manual Physical Therapy
Procedure: Corticosteroid Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Manual Physical Therapy Approach Versus Subacromial Corticosteroid Injection for Treatment of Shoulder Impingement Syndrome: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Madigan Army Medical Center:

Primary Outcome Measures:
  • Shoulder Pain and Disability Index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability). It is responsive to change and accurately discriminates between patients who are improving or worsening. It has high test-retest reliability and internal consistency. The minimal detectable change (MDC) is 18 and the minimally clinically important difference (MCID) is between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.


Secondary Outcome Measures:
  • Global Rating of Change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The GROC questionnaire is an instrument that measures overall changes in the quality of life of the subject. The use of a GROC is a common, feasible, and useful method for assessing outcome, and has been shown to be a valid measurement of change in patient status in other pain populations. A change in score of three rating points has been established as a clinically significant in the patients perception of quality of life. The GROC has 15 possible choices, with 0 being equal to no change and -1 to -7 indicating a negative change and +1 to +7 indicating a positive change.


Enrollment: 104
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Manual Physical Therapy
The orthopaedic manual physical therapy (OMPT) intervention approach used in this study will be based on an impairment model. The physical therapist providing the intervention will address the impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients will receive procedures tailored to their specific impairments. Procedures will include mobilizations and manipulations of the joint and soft-tissues.
Procedure: Manual Physical Therapy
Same as arm description
Other Names:
  • Orthopaedic Manual Physical Therapy
  • Manual Therapy
  • Osteopathic Manipulative Therapy
  • Manipulative Therapy
Active Comparator: Corticosteroid Injection (Subacromial)
Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Procedure: Corticosteroid Injection
Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
Other Name: Steroid Injection

Detailed Description:

Dysfunction in the shoulder has been reported to affect up to 33% of the general population and generate up to 5% of all consultations from general practitioners. Shoulder problems have been reported as the second highest musculoskeletal complaint for those seeking care from a physical therapist in a deployed environment. Impingement syndromes occur in nearly anyone who repeatedly or forcefully uses their upper extremity in an elevated position, which is very common in the active duty population, and is often characterized by pain during this motion. Managed improperly, this can lead to disruption in work performance and prolonged disability.

Corticosteroid and analgesic injections are some of the most common procedures for orthopedists, rheumatologists, and general practitioners to use in the management of shoulder pain. Conflicting reports from systematic reviews questions the efficacy of corticosteroid injections over other interventions, including oral non-steroidal anti-inflammatory drugs (NSAIDs). Additionally they are not without potential risk such as infection or deleterious effects of prolonged corticosteroid use to include tissue degeneration reported in animal studies as well as other regions of the human body. Manual physical therapy offers a non-invasive approach with negligible risk in as few as three to six sessions and has been shown to improve strength and function in this patient population.

The purpose of this study is to evaluate and compare the effectiveness of two interventions that are commonly used in the management of shoulder impingement syndrome.

  1. Evaluate the effect that a subacromial corticosteroid injection has on a subject's function and pain as measured by the Shoulder Pain and Disability Index (SPADI).
  2. Evaluate the effect that manual physical therapy has on a subject's function and pain as measured by the Shoulder Pain and Disability Index (SPADI).
  3. Compare the effect sizes of the two different interventions in a patient population with shoulder impingement syndrome.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-65
  • Read, write, and speak English
  • Tricare beneficiary and eligible for healthcare at a military MTF
  • Primary complaint of shoulder pain
  • Meets diagnostic criteria for shoulder impingement (mentioned below)

To be included in the study participants are required to have:

  1. pain with one of the 2 tests in category I, and
  2. pain with one test from either category II or category III. * "pain" is defined as reproduction of the usual pain that the subject experiences that makes up the nature of their complaint.

Category I: Impingement signs

  1. Passive overpressure at full shoulder flexion with the scapula stabilized.
  2. Passive internal rotation at 90 degrees of shoulder flexion in the scapular plane and in progressive degrees of horizontal adduction.

Category II: Active shoulder abduction Active shoulder abduction Category Ill: resisted break tests

  1. Abduction
  2. Internal rotation
  3. External rotation

Exclusion Criteria:

  • History of shoulder injection in last 3 months
  • History of shoulder dislocation, subluxation, fracture, adhesive capsulitis of the glenohumeral joint, or cervical/shoulder/upper back surgery
  • Full-thickness rotator cuff tears
  • Presence of cervical radiculopathy, radiculitis, or referral from cervical spine
  • Total baseline SPADI score not less than 20% (to prevent a ceiling effect with treatment)
  • Prior OMPT treatment to the involved limb for the current episode of pain
  • Military service members pending a medical evaluation board, a physical valuation board, or equivalent discharge process, or in medical hold to determine long term disposition. For non-military personnel, anyone that is pending or undergoing any litigation for their injury.
  • Contraindication to receiving a corticosteroid injection (allergies, adverse reactions, history of multiple injections in that area even if not within last 30 days, etc)
  • Inability to fill out informed consent form
  • Unable to come into the clinic for regular treatment over the course of the following month.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190891

Locations
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Madigan Army Medical Center
University of Puget Sound
Franklin Pierce University
Investigators
Principal Investigator: Daniel I Rhon, MPT, DPT, DSc Madigan Army Medical Center
Study Director: Joshua A Cleland, PT, DPT, PhD Franklin Pierce University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT01190891     History of Changes
Other Study ID Numbers: 111411-1
Study First Received: June 9, 2010
Last Updated: October 31, 2013
Health Authority: United States: Federal Government

Keywords provided by Madigan Army Medical Center:
Rotator cuff tendonitis
Shoulder pain
Shoulder impingement

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 21, 2014