Clinical trial NCT01427153: A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis
Official title: Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
physical therapy
corticosteroid
treatment
Lead sponsor: Madigan Army Medical Center
Sponsor class: FED
Collaborators: name: Brooke Army Medical Center
First posted: 2011-09-01
Enrollment: 156
Sex: ALL
Minimum age (years): 38
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Western Ontario McMasters Osteoarthritis Index (WOMAC)
timeFrame: 1 year
Secondary outcomes:
measure: Global Rating of Change (GROC)
timeFrame: 1 Year
measure: Alternate Step Test (AST)
timeFrame: 1 Year
measure: Timed Up and Go Test (TUG)
timeFrame: 1 Year
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Madigan Army Medical Center
name: Daniel Rhon, PT, DPT, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor University / Brooke Army Medical Center
name: Gail Deyle, PT, DPT, DSc
role: STUDY_DIRECTOR
affiliation: Baylor University
name: Steven Allison, PT, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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. doi: 10.1136/bmjopen-2015-010528corr1.