Expired Study
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Tacoma, Washington 98431


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

111411-1


NCT ID:

NCT01190891


Secondary ID:


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Madigan Army Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

104


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel I Rhon, MPT, DPT, DSc
Principal Investigator
Madigan Army Medical Center

Study Dates

Start Date:May 2010
Completion Date:December 2013
Completion Type:Anticipated
Primary Completion Date:March 2013
Primary Completion Type:Actual
Verification Date:October 2013
Last Changed Date:October 31, 2013
First Received Date:June 9, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Global Rating of Change
Time Frame:1 year
Safety Issues:False
Description: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 patien
Outcome Type:Primary Outcome
Measure:Shoulder Pain and Disability Index
Time Frame:1 year
Safety Issues:False
Description: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 reliabilit

Study Interventions

Intervention Type:Procedure
Name:Manual Physical Therapy
Description:Same as arm description
Arm Name:Manual Physical Therapy
Other Name:Orthopaedic Manual Physical Therapy
Intervention Type:Procedure
Name:Corticosteroid Injection
Description:Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
Arm Name:Corticosteroid Injection (Subacromial)
Other Name:Steroid Injection

Study Arms

Study Arm Type:Active Comparator
Arm Name:Corticosteroid Injection (Subacromial)
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
Study Arm Type:Active Comparator
Arm Name:Manual Physical Therapy
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 s

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Madigan Army Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Puget Sound

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:10721508
Reference Type:Reference
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.
PMID:20140151
Reference Type:Reference
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.
PMID:12792213
Reference Type:Reference
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. Review.
PMID:19841837
Reference Type:Reference
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.
PMID:17213378
Reference Type:Reference
Citation:Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8. Review.
PMID:15808040

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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