Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

NCT ID: NCT01190891

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-08-31

Brief 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.

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.

Conditions

Shoulder Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Manual Physical Therapy

Intervention Type: PROCEDURE

Same as arm description

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

Group Type: ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type: PROCEDURE

Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).

Interventions

Manual Physical Therapy

Same as arm description

Intervention Type: PROCEDURE

Corticosteroid Injection

Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).

Intervention Type: PROCEDURE

Other Intervention Names

Orthopaedic Manual Physical Therapy; Manual Therapy; Osteopathic Manipulative Therapy; Manipulative Therapy; Steroid Injection

Eligibility Criteria

Inclusion Criteria

• Age between 18-65
• Read, write, and speak English
• Tricare beneficiary and eligible for healthcare at a military treatment facility
• 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.

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

Sponsors

University of Puget Sound

OTHER

Sponsor Role: collaborator

Franklin Pierce University

OTHER

Sponsor Role: collaborator

Madigan Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Dan Rhon

Department Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel I Rhon, DPT, DSc

Role: PRINCIPAL_INVESTIGATOR

Madigan Army Medical Center

Joshua A Cleland, PhD

Role: STUDY_DIRECTOR

Franklin Pierce University

Locations

Madigan Army Medical Center

Tacoma, Washington, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 15808040 (View on PubMed)

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. doi: 10.5435/00124635-200701000-00002.

Reference Type: BACKGROUND

PMID: 17213378 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19841837 (View on PubMed)

Desmeules F, Cote CH, Fremont P. Therapeutic exercise and orthopedic manual therapy for impingement syndrome: a systematic review. Clin J Sport Med. 2003 May;13(3):176-82. doi: 10.1097/00042752-200305000-00009.

Reference Type: BACKGROUND

PMID: 12792213 (View on PubMed)

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. doi: 10.1179/106698109791352076.

Reference Type: BACKGROUND

PMID: 20140151 (View on PubMed)

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. doi: 10.2519/jospt.2000.30.3.126.

Reference Type: BACKGROUND

PMID: 10721508 (View on PubMed)

Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Ann Intern Med. 2014 Aug 5;161(3):161-9. doi: 10.7326/M13-2199.

Reference Type: DERIVED

PMID: 25089860 (View on PubMed)

Rhon DI, Boyles RE, Cleland JA, Brown DL. A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial. BMJ Open. 2011 Jan 1;1(2):e000137. doi: 10.1136/bmjopen-2011-000137.

Reference Type: DERIVED

PMID: 22021870 (View on PubMed)

Other Identifiers

111411-1

Identifier Type: -

Identifier Source: org_study_id