Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome
|ClinicalTrials.gov Identifier: NCT01190891|
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : April 29, 2016
Last Update Posted : April 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Impingement Syndrome||Procedure: Manual Physical Therapy Procedure: Corticosteroid Injection||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Manual Physical Therapy Approach Versus Subacromial Corticosteroid Injection for Treatment of Shoulder Impingement Syndrome: a Randomized Clinical Trial|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: Manual Physical Therapy
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
Same as arm description
Active Comparator: 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
Procedure: Corticosteroid Injection
Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
Other Name: Steroid Injection
- Shoulder Pain and Disability Index [ Time Frame: 1 year ]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.
- Global Rating of Change [ Time Frame: 1 year ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190891
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Daniel I Rhon, DPT, DSc||Madigan Army Medical Center|
|Study Director:||Joshua A Cleland, PhD||Franklin Pierce University|