Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

Shoulder Impingement Syndrome Clinical Trial

Official title:

A Manual Physical Therapy Approach Versus Subacromial Corticosteroid Injection for Treatment of Shoulder Impingement Syndrome: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01190891
• Other study ID #: 111411-1
• Status: Active, not recruiting
• Phase: N/A
• First received: June 9, 2010
• Last updated: October 31, 2013
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: Madigan Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

Procedure:
• Manual Physical Therapy
Same as arm description
• Corticosteroid Injection
Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Madigan Army Medical Center	Franklin Pierce University, University of Puget Sound

Country where clinical trial is conducted

United States, 

References & Publications (6)

Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8. Review. — View Citation

Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther. 2000 Mar;30(3):126-37. — View Citation

Camarinos J, Marinko L. Effectiveness of manual physical therapy for painful shoulder conditions: a systematic review. J Man Manip Ther. 2009;17(4):206-15. — View Citation

Desmeules F, Côté CH, Frémont P. Therapeutic exercise and orthopedic manual therapy for impingement syndrome: a systematic review. Clin J Sport Med. 2003 May;13(3):176-82. Review. — View Citation

Koester MC, Dunn WR, Kuhn JE, Spindler KP. The efficacy of subacromial corticosteroid injection in the treatment of rotator cuff disease: A systematic review. J Am Acad Orthop Surg. 2007 Jan;15(1):3-11. Review. — View Citation

Kromer TO, Tautenhahn UG, de Bie RA, Staal JB, Bastiaenen CH. Effects of physiotherapy in patients with shoulder impingement syndrome: a systematic review of the literature. J Rehabil Med. 2009 Nov;41(11):870-80. doi: 10.2340/16501977-0453. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index	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.	1 year	No
Secondary	Global Rating of Change	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.	1 year	No