An interventional study of Manual Physical Therapy and Corticosteroid Injection in Shoulder Impingement Syndrome, sponsored by Madigan Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-29.
Sponsored by Madigan Army Medical Center · Not applicable, Interventional, and Treatment
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.
304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.
This study's enrollment of 104 is above the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.
Browse Shoulder Impingement Syndrome studies →Madigan Army Medical Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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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:
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
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
Same as arm description
Also known as: Orthopaedic Manual Physical Therapy, Manual Therapy, Osteopathic Manipulative Therapy, Manipulative Therapy
Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
Also known as: Steroid Injection
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.
Time frame: 1 year
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.
Time frame: 1 year
| Milestone | Manual Physical Therapy | Corticosteroid Injection (Subacromial) |
|---|---|---|
| Started | 52 | 52 |
| Completed | 46 | 52 |
| Not completed | 6 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 0 |
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.
| units on a scale | Manual Physical Therapy | Corticosteroid Injection (Subacromial) |
|---|---|---|
| Shoulder Pain and Disability Index | 21.6 (16.0 to 27.2) | 23.1 (17.7 to 28.6) |
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.
| units on a scale | Manual Physical Therapy | Corticosteroid Injection (Subacromial) |
|---|---|---|
| Global Rating of Change | 3 (2 to 4) | 3 (2 to 4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Manual Physical Therapy | — | 0/46 (0%) | 0/46 (0%) |
| Corticosteroid Injection (Subacromial) | — | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Manual Physical Therapy | Corticosteroid Injection (Subacromial) | Total |
|---|---|---|---|
| Mean | 40 ± 12 | 42 ± 12 | 41 ± 12 |
| Sex: Female, Male(Participants) | Manual Physical Therapy | Corticosteroid Injection (Subacromial) | Total |
|---|---|---|---|
| Female | 17 | 14 | 31 |
| Male | 29 | 38 | 67 |
| Region of Enrollment(participants) | Manual Physical Therapy | Corticosteroid Injection (Subacromial) | Total |
|---|---|---|---|
| United States | 46 | 52 | 98 |
Plan to share: Yes — Data sharing can only occur after a Data Sharing Agreement has been approved by the US Defense Health Agency
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Shoulder Impingement Syndrome→
Madigan Army Medical Center