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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Madigan Army Medical Center
Sponsor:
Collaborator:
Brooke Army Medical Center
Information provided by (Responsible Party):
Dan Rhon, Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT01427153
First received: August 30, 2011
Last updated: July 18, 2013
Last verified: July 2013
  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:


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:
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 August 28, 2014