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

NCT01427153 | Completed

• 1 other identifier: 211081
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; physical therapy; corticosteroid; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Global Rating of Change (GROC)

  1 Year

• Alternate Step Test (AST)

  1 Year

• Timed Up and Go Test (TUG)

  1 Year

Study Arms (2)

Corticosteroid

ACTIVE COMPARATOR

Corticosteroid injection

Procedure: Corticosteroid Injection

Orthopaedic Manual Physical Therapy

ACTIVE COMPARATOR

OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.

Procedure: Orthopaedic manual physical therapy

Interventions

Orthopaedic manual physical therapy PROCEDURE

OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.

Orthopaedic Manual Physical Therapy

Corticosteroid Injection PROCEDURE

Corticosteroid injection to the tibiofemoral joint

Corticosteroid

Eligibility Criteria

• Age: 38 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• Brooke Army Medical Center: collaborator

Study Sites (2)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (7)

• 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.

  PMID: 16305269 BACKGROUND

• 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.

  PMID: 10651597 BACKGROUND

• 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.

  PMID: 19794221 BACKGROUND

• Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.

  PMID: 15000335 BACKGROUND

• 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.

  PMID: 35072722 DERIVED

• 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.

  PMID: 32268027 DERIVED

• 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.

  PMID: 27033961 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Daniel Rhon, PT, DPT, DSc

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

• Gail Deyle, PT, DPT, DSc

  Baylor University / Brooke Army Medical Center

  STUDY DIRECTOR

• Steven Allison, PT, PhD

  Baylor University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physical Therapist

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2012
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: January 27, 2025

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: These are all available in the supplementary appendix published in the trial results with NEJM
• Access Criteria: All of this data is publicly available in open access publications and in the supplementary appendix of the version published on NEJM

Locations

US (2)