Treatment of Meniscal Problems in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 879
- 试验地点
- 8
- 主要终点
- Change in Pain
研究概览
简要总结
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to manage meniscal tears in the presence of knee arthritis. Treatments include surgically removing the damaged part of the meniscus; strengthening exercises to improve pain and function; manual therapy including massage and mobilization; acupuncture; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy is no more effective than physical therapy by itself.
While physical therapy alone has been shown to result in similar pain relief as arthroscopic surgery, researchers have not yet done studies to determine what type of physical therapy is best for people with knee arthritis and meniscal tears. In the "TeMPO" Trial, we will be comparing 4 different, non-operative physical therapy regimens in order to gain a better understanding of how physical therapy works and what regimen will best reduce pain and improve function in persons with meniscal tear and osteoarthritis. The four arms in this randomized trial will contain different combinations of therapeutic treatments including in-clinic therapist-supervised exercise, in-clinic topical therapies, and exercises to be completed at home. Subjects in three of the arms will also receive motivational SMS (text) messages intended to improve adherence to the home exercise regimen.
TeMPO is designed as a randomized controlled trial. Participants will be assigned randomly to one of the four arms. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help us to understand what aspects of physical therapy actually make people feel better.
Our hypothesis is that subjects in the arm that includes in-clinic physical therapy and a home exercise regimen will experience more pain relief than subjects in each of the other arms. Also, we expect that subjects in the arm that receives the home exercise regimen and SMS messages will experience more pain relief than subjects in the arm that receives home exercise without the SMS messages.
详细描述
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to address meniscal tears in the presence of knee arthritis. These include surgically removing the damaged part of the meniscus; strengthening exercises; manual therapy including massage and mobilization; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy leads to similar levels of pain relief as physical therapy alone.
While physical therapy appears to be useful in knee osteoarthritis and meniscal tear, research is needed to determine what type of physical therapy is best for people with these conditions. The "TeMPO" Trial will compare 4 different non-operative regimens in order to gain a better understanding of how physical therapy works and to determine which regimen will best reduce participants' pain and improve their function. The four arms in this trial will contain different combinations of therapeutic treatments including in-clinic supervised exercise therapy, in-clinic topical therapies, and exercises to be completed at home. Some of the arms will also receive text messages designed to improve adherence to assigned exercises. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help identify the aspects of physical therapy that make people feel better.
The four arms in the TeMPO study are as follows:
- Home Exercise Program
- Home Exercise Program + Motivational SMS messages
- Home Exercise Program + Motivational SMS messages + In-Clinic topical therapy
- Home Exercise Program + Motivational SMS messages + In-Clinic Exercise Therapy
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will not be appraised of treatment arm.
入排标准
- 年龄范围
- 45 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee pain of at least 21 days duration if traumatic; no minimum duration if non-traumatic
- •Age 45 -85 years
- •Physician diagnosis of meniscal tear
- •Evidence on MRI of meniscal tear
- •Evidence of osteoarthritic changes on imaging: Cartilage damage on MRI, osteophyte or joint space narrowing on X-ray
排除标准
- •KL-Grade 4
- •Inflammatory arthritis
- •Prior APM or TKR on index knee; or any surgery on index knee in prior 6 mo
- •Pregnancy
- •Contraindication to MRI
- •Daily use of strong opioids
- •Intra-articular therapy in last 4 weeks
- •Non-English speaking
- •History of dementia
- •Currently resides in a nursing home
- •Current claimant of worker's compensation for this condition
结局指标
主要结局
Change in Pain
时间窗: Randomization to 3 months
Difference between arms in change in the KOOS Pain score over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1. Arm 4 vs. Arm 3)
次要结局
- Binary treatment failure indicator(Randomization to 3 months)
- Forty meter fast-paced walk(Randomization to 3 months)
- Strength of quadriceps, hamstrings, gluteus medius(Baseline to 3 months)
- Single Leg Balance(Baseline to 3 months)
- Change in quality of life(Randomization to 3 months)
- Change in function(Randomization to 3 months)
- 30-second sit to stand(Randomization to 3 months)
- Durability of pain relief(3-12 months)
研究者
Jeffrey Neil Katz, MD
Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital
