A Comparison of Manual Physical Therapy and Corticosteroid Injections for Knee Osteoarthritis - Full Text View

Purpose

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.

Condition	Intervention
Knee Osteoarthritis	Procedure: Orthopaedic manual physical therapy Procedure: Corticosteroid Injection


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup Osteoarthritis Steroids

U.S. FDA Resources

Further study details as provided by Madigan Army Medical Center:

Primary Outcome Measures:

Western Ontario McMasters Osteoarthritis Index (WOMAC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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.


Estimated Enrollment:	156
Study Start Date:	March 2012
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	38 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427153

Locations


United States, Texas
Brooke Army Medical Center	Recruiting
San Antonio, Texas, United States, 78234
Contact: Nasheda Sapp 210-808-2582 nasheda.sapp@amedd.army.mil
Principal Investigator: Gail Deyle, PT, DPT, DSc
Sub-Investigator: Norman Gill, PT, DSc
United States, Washington
Madigan Army Medical Center	Recruiting
Tacoma, Washington, United States, 98431
Contact: Julie Koepp 253-968-0780 julie.koepp@us.army.mil
Principal Investigator: Daniel Rhon, PT, DPT, DSc

Sponsors and Collaborators

Madigan Army Medical Center

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

More Information

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.

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.

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. Review.

Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8. Review. Erratum in: Can Fam Physician. 2009 Jun;55(6):590.


Responsible Party:	Dan Rhon, Staff Physical Therapist, Madigan Army Medical Center
ClinicalTrials.gov Identifier:	NCT01427153 History of Changes
Other Study ID Numbers:	113703
Study First Received:	August 30, 2011
Last Updated:	July 18, 2013
Health Authority:	United States: Federal Government

Keywords provided by Madigan Army Medical Center:


knee osteoarthritis physical therapy corticosteroid treatment

Additional relevant MeSH terms:


Osteoarthritis Osteoarthritis, Knee Arthritis	Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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