A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to compare an orthopaedic manual physical therapy (OMPT) to corticosteroid injection for the management of knee osteoarthritis.

Detailed Description
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The purpose of this study is to compare a commonly offered clinical approach of a series of intra-articular steroid injections to an orthopaedic manual physical therapy (OMPT) approach consisting of manually applied passive movement and reinforcing exercise for the treatment of osteoarthritis of the knee (knee OA). A second purpose is to validate a clinical prediction rule (CPR) for patients unlikely to respond to the orthopaedic manual physical therapy approach in a pre-planned secondary analysis of data from the randomized clinical trial. Aim 1: To see if there is a significant difference in pain and function lasting out to 1 year for patients that receive a clinical approach consisting of a series of intra-articular steroid injections compared to those that receive a clinical approach consisting of orthopaedic manual physical therapy. Aim 2: To validate a clinical prediction rule of characteristics identified in a previous preliminary study that predicted which patients with knee OA would be unlikely to respond to OMPT.

Official Title
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Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Orthopaedic manual physical therapy
* Procedure: Corticosteroid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must be eligible for care in the military health system Meet Altman's clinical criteria for knee OA Have English language skills sufficient to complete the WOMAC and GROC outcome instruments Be 38 years of age or older Exclusion Criteria: Steroid injections or physical therapy treatment for their knee in the past 12 months Current or past history of rheumatoid arthritis or similar rheumatic condition Current or past history of gout or pseudogout of the knee Active infection in the knee within the past 12 months Other physical ailment or condition that is typically more limiting or painful than their knee OA during activities such as sitting, standing, walking, or stair climbing History of allergy or adverse effect to corticosteroids Cannot speak/read English adequately to understand and provide consent to participate in the study Pregnant or intending to become pregnant Military service members pending a medical evaluation board, physical evaluation board, equivalent discharge process, or on medical hold to determine long-term disposition. For non-military personnel, anyone that is pending or undergoing any litigation for this condition. Contraindication to receiving a corticosteroid injection (history of allergic or adverse reaction to steroid injection, history of multiple corticosteroid injections in that area even if not within last year, etc) Unable to give informed consent to participate in the study.

Ages Eligible for Study
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Minimum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroid<br>Corticosteroid injection | Procedure: Corticosteroid Injection<br>* Corticosteroid injection to the tibiofemoral joint<br>|
| Active Comparator: Orthopaedic Manual Physical Therapy<br>OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques. | Procedure: Orthopaedic manual physical therapy<br>* OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario McMasters Osteoarthritis Index (WOMAC) | The WOMAC is a self report questionnaire that asks patient to rate their pain, stiffness, and functional limitation associated with their condition. This instrument will provide important information about the self-reported pain and disability level of the patients in this study. The WOMAC is a recommended primary outcome measure in therapy trials of arthritic conditions, and is considered one of the most appropriate scales for trials evaluating knee osteoarthritis (OA). It is a reliable, valid, and responsive instrument widely used in clinical trials evaluating therapy for hip and knee OA | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change (GROC) | The GROC questionnaire is a common, feasible, and useful method for assessing short term outcomes and overall changes in quality of life, and is a valid measurement of change in patient status in a variety of pain populations. The GROC has a 15-point scale with a change of positive three points or higher demonstrating clinically significant improvement in a patients perception of quality of life. | 1 Year | 
| Alternate Step Test (AST) | The Alternate Step Test is an inexpensive and efficient measure of dynamic postural stability and mobility. The AST requires participants to alternate feet and step 8 times (4 times for each foot) onto a 18 cm stool or step as rapidly as possible Recent evidence involving community dwelling adults also suggests that the AST has acceptable test-retest reliability (ICC=0.78) and potential as a fall risk assessment measure. | 1 Year | 
| Timed Up and Go Test (TUG) | The Timed Up and Go Test is a functional performance measure which directly evaluates an individual's ability to transfer, ambulate, and maintain balance during transitions. Individuals are timed on how quickly they can stand, walk 3 meters, turn around, and return to the chair and sit down. The TUG has good inter-rater and intra-rater reliability and validity for functional testing in older adults at risk for falls. The test is easy to administer and can be completed in two to three minutes. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, physical therapy, corticosteroid, treatment