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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Corticosteroid

Corticosteroid injection

Group Type ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type PROCEDURE

Corticosteroid injection to the tibiofemoral joint

Orthopaedic Manual Physical Therapy

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

Group Type ACTIVE_COMPARATOR

Orthopaedic manual physical therapy

Intervention Type PROCEDURE

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

Interventions

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Orthopaedic manual physical therapy

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

Intervention Type PROCEDURE

Corticosteroid Injection

Corticosteroid injection to the tibiofemoral joint

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No