A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis (SMART)
This study is currently recruiting participants.
Verified April 2012 by Madigan Army Medical Center
Sponsor:
Madigan Army Medical Center
Collaborator:
Brooke Army Medical Center
Information provided by (Responsible Party):
Dan Rhon, Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT01427153
First received: August 30, 2011
Last updated: April 18, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Knee Osteoarthritis |
Procedure: Orthopaedic manual physical therapy Procedure: Corticosteroid Injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee |
Resource links provided by NLM:
Further study details as provided by Madigan Army Medical Center:
Primary Outcome Measures:
- Western Ontario McMasters Osteoarthritis Index (WOMAC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Global Rating of Change (GROC) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]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.
- Alternate Step Test (AST) [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]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.
- Timed Up and Go Test (TUG) [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 156 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Corticosteroid
Corticosteroid injection
|
Procedure: Corticosteroid Injection
Corticosteroid injection to the tibiofemoral joint
|
|
Active Comparator: Orthopaedic Manual Physical Therapy
OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
|
Procedure: Orthopaedic manual physical therapy
OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
|
Eligibility| Ages Eligible for Study: | 38 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427153
Locations
| United States, Texas | |
| Brooke Army Medical Center | Recruiting |
| San Antonio, Texas, United States, 78234 | |
| Contact: Nasheda Sapp 210-808-2582 nasheda.sapp@amedd.army.mil | |
| Principal Investigator: Gail Deyle, PT, DPT, DSc | |
| Sub-Investigator: Norman Gill, PT, DSc | |
| United States, Washington | |
| Madigan Army Medical Center | Recruiting |
| Tacoma, Washington, United States, 98431 | |
| Contact: Julie Koepp 253-968-0780 julie.koepp@us.army.mil | |
| Principal Investigator: Daniel Rhon, PT, DPT, DSc | |
Sponsors and Collaborators
Madigan Army Medical Center
Brooke Army Medical Center
Investigators
| Principal Investigator: | Daniel Rhon, PT, DPT, DSc | Madigan Army Medical Center |
| Study Director: | Gail Deyle, PT, DPT, DSc | Baylor University / Brooke Army Medical Center |
| Study Chair: | Steven Allison, PT, PhD | Baylor University |
More Information
Publications:
| Responsible Party: | Dan Rhon, Staff Physical Therapist, Madigan Army Medical Center |
| ClinicalTrials.gov Identifier: | NCT01427153 History of Changes |
| Other Study ID Numbers: | 113703 |
| Study First Received: | August 30, 2011 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Madigan Army Medical Center:
|
knee osteoarthritis physical therapy corticosteroid treatment |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013