Knee OsteoarthritisSMARTNCT01427153
A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis
A study testing Orthopaedic manual physical therapy and Corticosteroid Injection in people with Knee Osteoarthritis, run by Madigan Army Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 38 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Orthopaedic manual physical therapy and Corticosteroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
San Antonio, Texas, 78234
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Orthopaedic manual physical therapy, Corticosteroid Injection
- Keywords
- knee osteoarthritis, physical therapy, corticosteroid, treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic manual physical therapyProcedure or surgery
OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
Corticosteroid InjectionProcedure or surgery
Corticosteroid injection to the tibiofemoral joint
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Active comparator | Corticosteroid injection Receives: Procedure: Corticosteroid Injection |
| Orthopaedic Manual Physical Therapy | Active comparator | OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques. Receives: Procedure: Orthopaedic manual physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2012
- Primary completionMay 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Brooke Army Medical Center
- Responsible party
- Principal investigator, Dan Rhon, Madigan Army Medical Center
- Investigators
- Daniel Rhon, PT, DPT, DSc, Principal investigator, Madigan Army Medical CenterGail Deyle, PT, DPT, DSc, Study director, Baylor University / Brooke Army Medical CenterSteven Allison, PT, PhD, Study chair, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427153
- Sponsor's protocol ID
- 211081
- Acronym
- SMART
- Status last verified
- Jul 2020
- First submitted
- 30 Aug 2011
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency
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.
PubMed 16305269Deyle 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.
PubMed 10651597Hepper 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.
PubMed 19794221Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.
PubMed 15000335Rhon 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.
PubMed 35072722Deyle 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.
PubMed 32268027Deyle 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.
PubMed 27033961
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01427153
- Acronym / sponsor ID
- SMART / 211081
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, physical therapy, corticosteroid, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- Brooke Army Medical Center
- Study start
- Aug 2012 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | Active comparator | Procedure: Corticosteroid InjectionCorticosteroid injection |
| Orthopaedic Manual Physical Therapy | Active comparator | Procedure: Orthopaedic manual physical therapyOMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques. |
Who may qualify
- Ages
- 38 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopaedic manual physical therapyOMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques. | Procedure or surgery | Orthopaedic Manual Physical Therapy |
| Corticosteroid InjectionCorticosteroid injection to the tibiofemoral joint | Procedure or surgery | Corticosteroid |
Primary outcome
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
3 secondary outcomes
Global Rating of Change (GROC)
Time frame: 1 Year
Alternate Step Test (AST)
Time frame: 1 Year
Timed Up and Go Test (TUG)
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Background: PubMed 16305269Deyle 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.
- Background: PubMed 10651597Deyle 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.
- Background: PubMed 19794221Hepper 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.
- Background: PubMed 15000335Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.
- Derived from this study: PubMed 35072722Rhon 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.
- Derived from this study: PubMed 32268027Deyle 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.
- Derived from this study: PubMed 27033961Deyle 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.
- Individual participant dataSharing planned: Yes. Any data sharing must go through a Data Sharing Agreement approved by the US Defense Health Agency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rhon, PT, DPT, DSc principal investigator
Madigan Army Medical Center
Gail Deyle, PT, DPT, DSc study director
Baylor University / Brooke Army Medical Center
Steven Allison, PT, PhD study chair
Baylor University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopaedic manual physical therapy and Corticosteroid Injection in people with Knee Osteoarthritis, run by Madigan Army Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario McMasters Osteoarthritis Index (WOMAC) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01427153, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.