The Enso Study for Chronic Low Back Pain (EPS)
A Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain
研究概览
详细说明
Fifty subjects will be selected based on the inclusion criteria and then randomized to either the intervention group or the sham control group. Each subject will be randomly fitted with an Enso or a sham device and will be instructed to self-administer treatment daily for one hour or more per day for four weeks in both cohorts. Throughout the duration of the study, data will be recorded via a smartphone application regarding treatment usage and intensity, pain levels, the subject's impression of any changes in their functionality, and their opioid and non-opioid medication intake. Medication usage will also be tracked through the use of CURES 2.0 information and pill counts at specified study visits. Additional functional testing will be conducted at each study visit.
At the 4 week visit, the study blind will be broken, and subjects who were randomized to the sham group will be given the opportunity to cross over for an additional week in the study, using the active device.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94143
- 招聘中
- University of California Medical Center
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接触:
- Bobby Tay, MD
- 电话号码:415-353-2739
- 邮箱:TayB@ucsf.edu
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接触:
- Krishn Khanna, MD
- 电话号码:719-510-9613
- 邮箱:Krishn.Khanna@ucsf.edu
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Mechanical (myofascial), axial back pain (focused around the spine)
- 6/10 or greater level of pain
- Functionally debilitated by their pain (e.g., difficulty walking)
- Minimal radicular symptoms with no effect on functionality, medication, quality of life
- Expressed desire to stop taking pain medications
- Expressed desire to improve disability
- 80% or greater of disability is due to pain in the low back (as opposed to other body areas)
- Experiencing chronic pain for at least 6 months
- Interested in being active, improving their functionality
- Comfortable with using technology in daily life
- Subject able to understand and grant informed consent
- Documented adherence with clinic follow up visits per medical records
- Has an email account
- Above 18 years old
Exclusion Criteria:
- Patients that do not own or have access to a smartphone
- Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
- Primary symptoms due to spinal stenosis
- 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
- Source of pain is a prior spinal fusion surgery
- Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
- 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 6 months
- Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion
- Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in the judgement of the investigator
- Inability to complete subjective data as required; e.g. on mobile application and questionnaires
- Pregnant women (as determined by self-report)
- Have severe epilepsy
- Have severe form of cardiovascular disease
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Active or Enso Group
Active Enso device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
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An active Enso device that delivers neuromodulation therapy.
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无干预:Sham Group
Sham device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Six Minute Walk Test
大体时间:Once a week for 4 weeks
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Compare the change in patient's 6 Minute Walk Test (6MWT) between the Enso intervention group and the sham group using the validated 6MWT procedure.
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Once a week for 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional back pain assessment
大体时间:Once a week for 4 weeks
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Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.
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Once a week for 4 weeks
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合作者和调查者
调查人员
- 首席研究员:Bobby Tay, MD、University of California, San Francisco
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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