Short-term and Intermediate-term Effects of Self-applied Joint Mobilization Versus Clinician-applied Joint Mobilization in Addition to Exercise in Patients With Knee Osteoarthritis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
The goal of this clinical trial is to learn if a combination of patient self-administered joint mobilization and exercise works to treat knee osteoarthritis in adults. The main questions it aims to answer are:
- Does self-administered joint mobilization improve the ability to perform regular daily activities?
- Does self-administered joint mobilization improve knee motion?
- Does self-administered joint mobilization improve hip strength?
Researchers will compare the program of self-administered joint mobilization to a joint mobilization administered by a physical therapist.
Participants will:
- Attend 8-12 physical therapy clinic visits over 6 - 8 weeks
- Perform home exercises
- Visit the clinic 6 months later for a brief check-up
详细描述
This study will take place in the Outpatient Rehabilitation Clinic at Texas Health Resources (THR) in Plano, or in the Texas Health Sports Medicine Clinic in Allen.
Participants in this study will be asked to complete the same intake forms and questionnaires as any other physical therapy patient being seen for knee pain at all of the THR physical therapy clinics. These will include questions about health history, learning style, living situation, and goals for physical therapy treatment. One investigator will perform a physical therapy evaluation, including joint motion, muscle strength, and flexibility measurements, as well as functional testing.
For this study, we will measure one knee motion and one hip strength item and ask participants to complete a knee- specific questionnaire 3 times: on the initial evaluation visit, during the last visit of physical therapy, and during a 6-month follow-up visit.
After the initial evaluation visit, we will assign each participant into one of the two treatment groups, self-joint mobilization or joint mobilization performed by a physical therapist. Participants will be asked to attend 7 - 11 physical therapy treatment visits over 7-8 weeks for strength training exercises, flexibility exercises, joint mobilization, and a home exercise program. Each physical therapy visit, including the initial evaluation visit will last 45 minutes. Participants will be asked to track compliance with a home program and attend a follow-up appointment about 6 months after the initial evaluation. This follow-up visit will last about 30 minutes.
All appointments, except for the 6-month follow-up, will be structured and carried out as they would for any other patient receiving physical therapy for knee pain.
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
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets National Institute for Health and care Excellence (NICE) criteria for knee osteoarthritis:
- •Age 45 years or older
- •Movement-related knee pain
- •No morning stiffness or morning stiffness < 30 minutes
- •Knee flexion contracture (kFC) at least 1cm, measured by heel-height
- •Fluency in verbal and written English for completion of outcome measure and screening, and to take directions.
- •Able to attend all study-related appointments
排除标准
- •Assistive device required for ambulation
- •Systemic disease affecting joint function (diabetes, rheumatological disorders, etc)
- •Previous lower extremity joint replacement
- •Lower quarter surgery, injection, or therapy in the past year
- •Other functionally-limiting physical impairment of the lower quarter
- •Spine or lower extremity compensation claim (work, accident, etc)
结局指标
主要结局
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months
The WOMAC is a self-administered questionnaire assessing pain, stiffness, and physical function in patients with knee osteoarthritis.
次要结局
- Hip abductor strength(Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months)
- Passive knee extension range of motion(Baseline (enrollment), 6-8 weeks (end of in-clinic physical therapy), 6 months)
