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

January 23, 2025 updated by: Dan Rhon, Madigan Army Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Year
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.
1 Year
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.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Madigan Army Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimated)

September 1, 2011

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency

IPD Sharing Time Frame

These are all available in the supplementary appendix published in the trial results with NEJM

IPD Sharing Access Criteria

All of this data is publicly available in open access publications and in the supplementary appendix of the version published on NEJM

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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