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

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ClinicalTrials.gov Identifier: NCT01427153
Recruitment Status : Unknown
Verified July 2017 by Dan Rhon, Madigan Army Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2011
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Brooke Army Medical Center
Information provided by (Responsible Party):
Dan Rhon, Madigan Army Medical Center

Tracking Information
First Submitted Date  ICMJE August 30, 2011
First Posted Date  ICMJE September 1, 2011
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE August 2012
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2011)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis
Official Title  ICMJE Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Procedure: Orthopaedic manual physical therapy
    OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
  • Procedure: Corticosteroid Injection
    Corticosteroid injection to the tibiofemoral joint
Study Arms  ICMJE
  • Active Comparator: Corticosteroid
    Corticosteroid injection
    Intervention: Procedure: Corticosteroid Injection
  • Active Comparator: Orthopaedic Manual Physical Therapy
    OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
    Intervention: Procedure: Orthopaedic manual physical therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 31, 2011)
156
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 38 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01427153
Other Study ID Numbers  ICMJE 211081
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency
Responsible Party Dan Rhon, Madigan Army Medical Center
Study Sponsor  ICMJE Madigan Army Medical Center
Collaborators  ICMJE Brooke Army Medical Center
Investigators  ICMJE
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
PRS Account Madigan Army Medical Center
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP