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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthopaedic manual physical therapy
Corticosteroid Injection
Sponsored by
Madigan Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, physical therapy, corticosteroid, treatment

Eligibility Criteria

38 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brooke Army Medical Center
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Corticosteroid

Orthopaedic Manual Physical Therapy

Arm Description

Corticosteroid injection

OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 30, 2011
Last Updated
July 31, 2017
Sponsor
Madigan Army Medical Center
Collaborators
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01427153
Brief Title
A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis
Acronym
SMART
Official Title
Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Madigan Army Medical Center
Collaborators
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, physical therapy, corticosteroid, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
Corticosteroid injection
Arm Title
Orthopaedic Manual Physical Therapy
Arm Type
Active Comparator
Arm Description
OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
Intervention Type
Procedure
Intervention Name(s)
Orthopaedic manual physical therapy
Intervention Description
OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
Intervention Type
Procedure
Intervention Name(s)
Corticosteroid Injection
Intervention Description
Corticosteroid injection to the tibiofemoral joint
Primary Outcome Measure Information:
Title
Western Ontario McMasters Osteoarthritis Index (WOMAC)
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Global Rating of Change (GROC)
Description
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.
Time Frame
1 Year
Title
Alternate Step Test (AST)
Description
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.
Time Frame
1 Year
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Rhon, PT, DPT, DSc
Organizational Affiliation
Madigan Army Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gail Deyle, PT, DPT, DSc
Organizational Affiliation
Baylor University / Brooke Army Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven Allison, PT, PhD
Organizational Affiliation
Baylor University
Official's Role
Study Chair
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency
Citations:
PubMed Identifier
16305269
Citation
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.
Results Reference
background
PubMed Identifier
10651597
Citation
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. doi: 10.7326/0003-4819-132-3-200002010-00002.
Results Reference
background
PubMed Identifier
19794221
Citation
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. doi: 10.5435/00124635-200910000-00006.
Results Reference
background
PubMed Identifier
15000335
Citation
Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8. Erratum In: Can Fam Physician. 2009 Jun;55(6):590.
Results Reference
background
PubMed Identifier
35072722
Citation
Rhon DI, Kim M, Asche CV, Allison SC, Allen CS, Deyle GD. Cost-effectiveness of Physical Therapy vs Intra-articular Glucocorticoid Injection for Knee Osteoarthritis: A Secondary Analysis From a Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2142709. doi: 10.1001/jamanetworkopen.2021.42709.
Results Reference
derived
PubMed Identifier
32268027
Citation
Deyle GD, Allen CS, Allison SC, Gill NW, Hando BR, Petersen EJ, Dusenberry DI, Rhon DI. Physical Therapy versus Glucocorticoid Injection for Osteoarthritis of the Knee. N Engl J Med. 2020 Apr 9;382(15):1420-1429. doi: 10.1056/NEJMoa1905877.
Results Reference
derived
PubMed Identifier
27033961
Citation
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.
Results Reference
derived

Learn more about this trial

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

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