Digital Home Exercise Program Versus Standard of Care for Chronic OA-related Knee Pain: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥ 18 years)
- •Living in the tristate area - CT/NY/NJ
- •Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA)
- •Chronic knee pain (>3 months) as a primary pain complaint
- •Average pain score ≥ 4 on an 11-point numeric rating scale at baseline
- •Access to a device with internet connection
- •KL Stages 1-2-3
排除标准
- •Prior documented history of cognitive impairment;
- •History of total knee arthroplasty;
- •History of: Inflammatory arthritis (e.g. rheumatoid arthritis); or any neuropathies affecting the lower limbs, spinal cord injury, spine fractures, advanced heart disease, bleeding issues (i.e. hemophilia), surgery within the last 90 days; fall within 90 days; high risk of fracture;
- •History of knee injury, within the last 3 months;
- •Currently engaged with other PT or strengthening program;
- •Present unstable/uncontrolled cardiovascular condition
- •Undergoing active chemotherapy for cancer
研究组 & 干预措施
Technology-implemented exercise therapy
Therapy plans performed at home overseen by a remote physical therapist via SimpleTherapy. Allocation to this group will require using smart devices or a computer/laptop to receive care. Remote visits with a PT typically last 45min long and home exercises suggested by the app are self-paced.
干预措施: Technology-implemented exercise therapy (Other)
Traditional Physical Therapy
Participants will be prescribed an exercise plan by a physical therapist as normally would occur as part of standards of care outside the context of a research study. In-person assessments and at-home exercise suggestions will be decided by the physical therapist. Duration of PT appointments is typically 45 minutes long two times per week and are supplemented by PT recommended self-paced at-home exercises.
干预措施: Traditional Physical Therapy (Other)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 12 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline Week 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, activities of daily living (ADLs), sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline Week 2
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.
次要结局
- Brief Pain Inventory(12 weeks)
- Difficulty of exercises (PT arm)(12 weeks)
- PSEQ-2 (Pain Self efficacy questionnaire-SF 2)(12 weeks)
- Work Productivity and Activity Impairment (WPAI)(12 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS)(12 weeks)
- PGI-C (Patient global impression of change)(12 weeks)
- Subjective questionnaire (ST arm)(12 weeks)
- Medication (PT arm)(12 weeks)
- Tampa Kinesiophobia Scale(12 weeks)
- Pain Catastrophizing Scale(12 weeks)
- Number of exercises completed (PT arm)(12 weeks)
- Brief Pain Inventory - short form (BPI-SF)(Baseline Week 0)
- Tampa Kinesiophobia Scale (TSK)(Baseline Week 0)
- Brief Pain Inventory(Baseline Week 2)
- Patient Reported Outcomes Measurement Information System (PROMIS)(Baseline Week 0)
- Patient Reported Outcomes Measurement Information System (PROMIS)(Baseline Week 2)
- PSEQ-2 (Pain Self efficacy questionnaire-SF 2)(Baseline Week 0)
- PSEQ-2 (Pain Self efficacy questionnaire-SF 2)(Baseline Week 2)
- Work Productivity and Activity Impairment (WPAI)(Baseline Week 0)
- Work Productivity and Activity Impairment (WPAI)(Baseline Week 2)
- PGI-C (Patient global impression of change)(Baseline Week 0)
- PGI-C (Patient global impression of change)(Baseline Week 2)
- Tampa Kinesiophobia Scale(Baseline Week 2)
- Pain Catastrophizing Scale(Baseline Week 0)
- Pain Catastrophizing Scale(Baseline Week 2)
研究者
David Putrino
Professor
Icahn School of Medicine at Mount Sinai