A Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Six Minute Walk Test
研究概览
简要总结
Enso is a portable device for the treatment of chronic and acute types of musculoskeletal pain. This study is being designed as a double-blinded, sham-controlled randomized clinical trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Devices are assigned per the randomization schedule, with the sham device identical to the active device in every way except that no neuromodulation is delivered. The neuromodulation that the active device delivers can be done in a way that causes no sensation, so subjects are not unmasked.
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
- •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
排除标准
- •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
结局指标
主要结局
Six Minute Walk Test
时间窗: Once a week for 4 weeks
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.
次要结局
- Functional back pain assessment(Once a week for 4 weeks)