Enso Pilot Study for Chronic Low Back Pain

Study Overview
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Brief Summary
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Enso is a portable device for the treatment of chronic and acute types of musculoskeletal pain. This study is being designed as a single blind, sham-controlled randomized clinical trial.

Detailed Description
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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 two 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. Additional functional testing will be conducted at each study visit. At the 2 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 2 week period using the active device.

Official Title
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A Multicenter Randomized Controlled Trial Evaluating the Effectiveness of the Enso Device for Treatment of Chronic Low Back Pain in Relation to Study Entry Criteria

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: ENSO Device
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Walk no further than 250 meters during a pre-study administration of the Six Minute Walk Test Confirm that either they are able on their own to place the device (i.e., the gel pad) in its proper location, or they have a caretaker or family member who can assist them if needed 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 Subject who, in the Investigator's opinion, does not demonstrate a strong desire to reduce opioid or other pain medication usage (e.g., opioid dependence) 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 Prior spinal fusion surgery Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device Has radicular pain symptoms that account for more than 20% of their pain and/or functional impairment 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blind, randomized, sham controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active or ENSO Group<br>Active ENSO device use for two weeks, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage. | Device: ENSO Device<br>* An active ENSO device that delivers neuromodulation therapy.<br>|
| Sham Comparator: Sham Group<br>Sham device use for two weeks, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage. | Device: Sham Device<br>* Sham Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test | 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. | Once a week for two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional back pain assessment | Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT. | Once a week for two weeks |