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

Madigan Army Medical Center

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Procedure: Corticosteroid Injection

Procedure: Orthopaedic manual physical therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01427153

211081

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 patients

Sex

All

Ages

38+ years old

Volunteers

No 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.