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| Name | Class |
|---|---|
| University of Puget Sound | OTHER |
| Franklin Pierce University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Physical Therapy | Procedure | Same as arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
To be included in the study participants are required to have:
Category I: Impingement signs
Category II: Active shoulder abduction Active shoulder abduction Category Ill: resisted break tests
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Rhon, DPT, DSc | Madigan Army Medical Center | Principal Investigator |
| Joshua A Cleland, PhD | Franklin Pierce University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15808040 | Background | Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8. | |
| 17213378 | 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. |
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Data sharing can only occur after a Data Sharing Agreement has been approved by the US Defense Health Agency
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Physical Therapy | The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues. Manual Physical Therapy: Same as arm description |
| FG001 | 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 Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Physical Therapy | Manual Physical Therapy: Same as arm description |
| BG001 | 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 Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Physical Therapy | The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues. Manual Physical Therapy: Same as arm description |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Troy Patience, Research Operations Service | Madigan Army Medical Center | (253) 968-1160 | usarmy.jblm.medcom-mamc.mbx.dci@mail.mil |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| D000070636 | Rotator Cuff Injuries |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026301 | Manipulation, Osteopathic |
| D000305 | Adrenal Cortex Hormones |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Corticosteroid Injection | Procedure | Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg). |
|
|
| 1 year |
| 19841837 | 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. |
| 12792213 | 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. |
| 20140151 | 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. |
| 10721508 | 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. |
| 25089860 | Derived | 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. |
| 22021870 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg). |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 year |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | 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 Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg). | 0 | 52 | 0 | 52 |
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| D012421 |
| Rupture |
| D013708 | Tendon Injuries |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |