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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
Sponsored by
Madigan Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

Sites / Locations

  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

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

First Posted
June 9, 2010
Last Updated
March 28, 2016
Sponsor
Madigan Army Medical Center
Collaborators
University of Puget Sound, Franklin Pierce University
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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
No

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
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.
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
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Global Rating of Change
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 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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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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