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

Knee Osteoarthritis Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01427153
• Other study ID #: 211081
• Status: Active, not recruiting
• Phase: N/A
• First received: August 30, 2011
• Last updated: July 31, 2017
• Start date: August 2012
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Madigan Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: December 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Orthopaedic manual physical therapy
OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
• Corticosteroid Injection
Corticosteroid injection to the tibiofemoral joint

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Madigan Army Medical Center	Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Review. Erratum in: Can Fam Physician. 2009 Jun;55(6):590. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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.	1 Year
Secondary	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.	1 Year
Secondary	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.	1 Year