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Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

Primary Purpose

Shoulder Impingement Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Manual Physical Therapy

Corticosteroid Injection

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Rotator cuff tendonitis, Shoulder pain, Shoulder impingement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

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.

Sites / Locations

Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Manual Physical Therapy

Corticosteroid Injection (Subacromial)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01190891

First Posted

June 9, 2010

Last Updated

March 28, 2016

Sponsor

Madigan Army Medical Center

Collaborators

University of Puget Sound, Franklin Pierce University

1. Study Identification

Unique Protocol Identification Number

NCT01190891

Brief Title

Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Madigan Army Medical Center

Collaborators

University of Puget Sound, Franklin Pierce University

4. Oversight

Data Monitoring Committee

5. Study Description

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. 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). 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). Compare the effect sizes of the two different interventions in a patient population with shoulder impingement syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Impingement Syndrome

Keywords

Rotator cuff tendonitis, Shoulder pain, Shoulder impingement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manual Physical Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Corticosteroid Injection (Subacromial)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Manual Physical Therapy

Other Intervention Name(s)

Orthopaedic Manual Physical Therapy, Manual Therapy, Osteopathic Manipulative Therapy, Manipulative Therapy

Intervention Description

Same as arm description

Intervention Type

Procedure

Intervention Name(s)

Corticosteroid Injection

Other Intervention Name(s)

Steroid Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Shoulder Pain and Disability Index

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Global Rating of Change

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel I Rhon, DPT, DSc

Organizational Affiliation

Madigan Army Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joshua A Cleland, PhD

Organizational Affiliation

Franklin Pierce University

Official's Role

Study Director

Facility Information:

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98431

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data sharing can only occur after a Data Sharing Agreement has been approved by the US Defense Health Agency

Citations:

PubMed Identifier

15808040

Citation

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

Results Reference

background

PubMed Identifier

17213378

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. doi: 10.5435/00124635-200701000-00002.

Results Reference

background

PubMed Identifier

19841837

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.

Results Reference

background

PubMed Identifier

12792213

Citation

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.

Results Reference

background

PubMed Identifier

20140151

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. doi: 10.1179/106698109791352076.

Results Reference

background

PubMed Identifier

10721508

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. doi: 10.2519/jospt.2000.30.3.126.

Results Reference

background

PubMed Identifier

25089860

Citation

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.

Results Reference

derived

PubMed Identifier

22021870

Citation

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.

Results Reference

derived

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Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

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