NCT05821530进行中（未招募）不适用
A Randomized Controlled Clinical Trial Evaluating the Effectiveness of High-frequency Impulse Therapy (HFIT) Versus Transcutaneous Electronic Nerve Stimulator (TENS) for Treatment of Chronic Low Back and Knee Pain
Hinge Health, Inc2 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2023年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 325
- 试验地点
- 2
- 主要终点
- Pain MCID
研究概览
简要总结
A high-frequency impulse therapy (HFIT) device (Enso, San Francisco, CA) is a portable device for the treatment of musculoskeletal pain. This three-arm randomized controlled trial study compares a HFIT group to a standard transcutaneous electrical nerve stimulator (TENS) group and a control group.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or over and under age 65
- •Baseline pain is 40 or more out of 100 on a NPRS
- •Member of digital MSK program's chronic back or knee pain program, after January 1, 2023
- •Member engaged in the most recent 3 weeks
- •Experiencing chronic pain for at least 3 months
- •Subject able to understand and provide informed consent
- •Has an email account
排除标准
- •Diagnosis of cancer/malignant tumors in the last 5 years
- •Back or knee surgery in the last 6 months
- •Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device
- •Patients with history of opioid, alcohol, or drug abuse in the last 1 year
- •Cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, Parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol
- •Pregnant or plan on becoming pregnant in the next year
- •Have epilepsy
- •Have cardiovascular disease
- •Current pain (in the past 24 hours) is less than 40 out of 100 on a NPRS
结局指标
主要结局
Pain MCID
时间窗: Baseline and Week 4
Pain will be measured by the Numeric Pain Rating Scale, ranging from 0 (no pain) to 100 (worst possible pain). The minimal clinically important difference (MCID) of pain will be achieved (0/1) if there is at least a 34% or 23 point improvement, as based on literature.
次要结局
- Function MCID (Knee)(Baseline and Week 4)
- Opioid use(Baseline and Week 4)
- Function MCID (Back)(Baseline and Week 4)
- Anxiety(Baseline and Week 4)
- Depression(Baseline and Week 4)
研究者
研究点 (2)
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