The Hinge Health and ENSO Back Pain Study: Prospective, Open-label, Randomized Superiority Trial of a Digital Health Program and High Frequency Impulse Therapy (HFIT) Versus Standard of Care in Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Change in Pain
研究概览
简要总结
The goal of this study is to examine the extent to which Hinge Health, a digital musculoskeletal program, and Enso, a wearable pain relief device, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for chronic lower back pain.
详细描述
Digital health approaches are a way to deliver conservative therapy through interactive methods. These approaches may expand access to care due to the convenience of digital health, as participants can access care services at all hours and locations. Research has shown that participants of digital health programs show significant improvements in pain.
Hinge Health is a digital musculoskeletal (MSK) program that aims to help people manage their MSK pain through exercise, education, and personal coaching. In previous research, Hinge Health has shown improvements in pain, functional, and health care use outcomes. Enso is a portable device for the treatment of chronic and acute types of MSK pain. The electrical pulses delivered by Enso incorporate neuromodulation at high frequency (0.1 to 10 MHz) in addition to the low frequency (0 to 1 KHz) pulses transmitted by more traditional transcutaneous electrical nerve stimulation (TENS) units. The result is a unique mechanism of action compared to the paresthesia resulting from the electrical pulses delivered by traditional TENS devices. Furthermore, Enso has shown promising clinical outcomes in a small, pilot RCT.
While the pilot study provided preliminary results demonstrating clinical improvements in the short term, there is a need for evidence about medium to long term outcomes, impact on mood, and the effect on healthcare utilization. Therefore, the purpose of this study is to examine the extent to which Hinge Health, with Enso, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for their chronic lower back pain in the medium and long term.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or over
- •United Healthcare (UHC) is primary health plan
- •Mechanical (myofascial), axial back pain (focused around the spine)
- •Experiencing pain primarily in the low back area
- •Radicular component of pain has minimal effect on functionality, medication, quality of life
- •Experiencing low back pain for at least 3 months
- •Subject able to understand and provide informed consent
- •Comfortable and willing to accept random assignment to one of two study conditions (intervention or standard care condition)
- •Has an email account
排除标准
- •Patients that do not own or have access to a smartphone or tablet
- •Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
- •Primary symptoms due to spinal stenosis as evidenced by pseudoclaudication, leg weakness or numbness
- •Source of back pain related to an acute nerve impingement
- •Diagnosis of cancer/malignant tumors in the last 5 years
- •Source of back pain is an infection
- •History of spinal fusion surgery
- •Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, or any other implanted electronic device
- •Has had myocardial infarction within the past 6 months
- •Has had a coronary stent in the past 3 months
- •Has radicular pain symptoms that affect functionality, quality of life or medication intake
- •Has undergone surgery to solve pain related to the study indication in the past 12 months
- •Is scheduled for upcoming surgery to solve pain related to the study indication
- •History of opioid or drug use, or excessive alcohol use (excessive alcohol use defined as greater than 3 drinks a day on average), per investigator discretion
- •History of rheumatological or other inflammatory conditions such as rheumatoid arthritis, systemic lupus, erythematosus, etc.
- •Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in investigator's judgment
- •Pregnant women (as determined by self-report)
- •Has a heart condition that limits the ability to do mild exercise due to symptoms such as fatigue, palpitations, shortness of breath, or chest pain
- •Has any health condition that limits the ability to do light-intensity exercise such as slow walking or light household chores
- •Diagnosed with dementia or a similar memory disorder
- •Has had a fall in the past three months
- •Unable to move from sitting to standing without help from another person
- •Unable to stand without assistance from another person or device
- •Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes
- •Inability to complete data collection as required
- •No secondary/coinsurance or plans to change insurance from UHC in the next 3 months
- •Patients who were recommended spine surgery from a spine surgeon in the 3 months prior to the index month
研究组 & 干预措施
Hinge Health + Enso
The intervention group will receive access to the Hinge Health program and an Enso device.
干预措施: Digital Musculoskeletal (MSK) Program (Behavioral)
Hinge Health + Enso
The intervention group will receive access to the Hinge Health program and an Enso device.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Standard of Care
The control group will continue to receive access to traditional medical care for their musculoskeletal needs through their healthcare provider.
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Change in Pain
时间窗: Baseline, 2, 6, and 12 weeks
Pain in the last 24 hours and at its worst in the last week will be measured via a Numerical Pain Rating Score (NPRS) with 0 indicating no pain and 100 indicating worst imaginable pain.
次要结局
- Function(Baseline, 2, 6, and 12 weeks)
- Depression(Baseline, 2, 6, and 12 weeks)
- Anxiety(Baseline, 2, 6, and 12 weeks)