Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

NCT01190891 | Completed Results

• 1 other identifier: 111411-1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome

Keywords

Rotator cuff tendonitis; Shoulder pain; Shoulder impingement

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index

  The SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability), with higher scores indicating greater 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

Secondary Outcomes (1)

• Global Rating of Change

  1 year

Study Arms (2)

Manual Physical Therapy

ACTIVE COMPARATOR

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

Corticosteroid Injection (Subacromial)

ACTIVE COMPARATOR

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

Interventions

Manual Physical Therapy PROCEDURE

Same as arm description

Also known as: Orthopaedic Manual Physical Therapy, Manual Therapy, Osteopathic Manipulative Therapy, Manipulative Therapy

Manual Physical Therapy

Corticosteroid Injection PROCEDURE

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

Also known as: Steroid Injection

Corticosteroid Injection (Subacromial)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• pain with one of the 2 tests in category I, and
• 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
• Passive overpressure at full shoulder flexion with the scapula stabilized.
• 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
• Abduction
• Internal rotation
• External rotation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• University of Puget Sound: collaborator
• Franklin Pierce University: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (8)

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

  PMID: 15808040 BACKGROUND

• 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.

  PMID: 17213378 BACKGROUND

• 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.

  PMID: 19841837 BACKGROUND

• 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.

  PMID: 12792213 BACKGROUND

• 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.

  PMID: 20140151 BACKGROUND

• 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.

  PMID: 10721508 BACKGROUND

• 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.

  PMID: 25089860 DERIVED

• 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.

  PMID: 22021870 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Rotator Cuff Injuries; Shoulder Pain

Interventions

Musculoskeletal Manipulations; Manipulation, Osteopathic; Adrenal Cortex Hormones; Steroids

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Troy Patience, Research Operations Service
• Organization: Madigan Army Medical Center

usarmy.jblm.medcom-mamc.mbx.dci@mail.mil

(253) 968-1160

Study Officials

• Daniel I Rhon, DPT, DSc

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

• Joshua A Cleland, PhD

  Franklin Pierce University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Research Director

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: August 30, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 29, 2016
• Results First Posted: April 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)