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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Procedure: Orthopaedic manual physical therapy; Procedure: Corticosteroid Injection	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	156 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee
Actual Study Start Date :	August 2012
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Western Ontario McMasters Osteoarthritis Index (WOMAC) [ Time Frame: 1 year ]
   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 :

1. Global Rating of Change (GROC) [ Time Frame: 1 Year ]
   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.
2. Alternate Step Test (AST) [ Time Frame: 1 Year ]
   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.
3. Timed Up and Go Test (TUG) [ Time Frame: 1 Year ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	38 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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Locations

United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431

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

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Publications:

Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.

Deyle GD, Henderson NE, Matekel RL, Ryder MG, Garber MB, Allison SC. Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee. A randomized, controlled trial. Ann Intern Med. 2000 Feb 1;132(3):173-81.

Hepper CT, Halvorson JJ, Duncan ST, Gregory AJ, Dunn WR, Spindler KP. The efficacy and duration of intra-articular corticosteroid injection for knee osteoarthritis: a systematic review of level I studies. J Am Acad Orthop Surg. 2009 Oct;17(10):638-46. Review.

Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8. Review. Erratum in: Can Fam Physician. 2009 Jun;55(6):590.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Deyle GD, Gill NW, Rhon DI, Allen CS, Allison SC, Hando BR, Petersen EJ, Dusenberry DI, Bellamy N. A multicenter randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injection on pain and function related to knee osteoarthritis (PTA Trial). BMJ Open. 2016 Mar 31;6(3):e010528. doi: 10.1136/bmjopen-2015-010528. Erratum in: BMJ Open. 2016 May 04;6(5):e010528corr1.

Responsible Party:	Dan Rhon, Staff Physical Therapist, Madigan Army Medical Center
ClinicalTrials.gov Identifier:	NCT01427153 History of Changes
Other Study ID Numbers:	211081
First Posted:	September 1, 2011
Last Update Posted:	August 1, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency

Keywords provided by Dan Rhon, Madigan Army Medical Center:

knee osteoarthritis; physical therapy; corticosteroid; treatment

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis	Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases