Orthopaedic Manual Physical Therapy Versus Corticosteroid Injections for Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- Western Ontario McMasters Osteoarthritis Index (WOMAC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 38 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Corticosteroid
Corticosteroid injection
干预措施: Corticosteroid Injection (Procedure)
Orthopaedic Manual Physical Therapy
OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
干预措施: Orthopaedic manual physical therapy (Procedure)
结局指标
主要结局
Western Ontario McMasters Osteoarthritis Index (WOMAC)
时间窗: 1 year
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
次要结局
- Alternate Step Test (AST)(1 Year)
- Timed Up and Go Test (TUG)(1 Year)
- Global Rating of Change (GROC)(1 Year)
研究者
Dan Rhon
Staff Physical Therapist
Madigan Army Medical Center