Enso Pilot Study for Chronic Low Back Pain

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.

Inclusion Criteria:

1. Walk no further than 250 meters during a pre-study administration of the Six Minute
Walk Test

2. 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

3. Mechanical (myofascial), axial back pain (focused around the spine)

4. 6/10 or greater level of pain

5. Functionally debilitated by their pain (e.g., difficulty walking)

6. Minimal radicular symptoms with no effect on functionality, medication, quality of
life

7. Expressed desire to stop taking pain medications

8. Expressed desire to improve disability

9. 80% or greater of disability is due to pain in the low back (as opposed to other body
areas)

10. Experiencing chronic pain for at least 6 months

11. Interested in being active, improving their functionality

12. Comfortable with using technology in daily life

13. Subject able to understand and grant informed consent

14. Documented adherence with clinic follow up visits per medical records

15. Has an email account

16. Above 18 years old

Exclusion Criteria:

1. Patients that do not own or have access to a smartphone

2. 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)

3. Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis
with instability

4. Primary symptoms due to spinal stenosis

5. Source of back pain related to an acute nerve impingement

6. Diagnosis of cancer/malignant tumors in the last 5 years

7. Source of back pain is an infection

8. Prior spinal fusion surgery

9. Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device

10. Has radicular pain symptoms that account for more than 20% of their pain and/or
functional impairment

11. Has undergone surgery to solve pain related to the study indication in the past 6
months

12. Patients with history of opioid, alcohol or drug abuse in the last 5 years, per
investigator discretion

13. 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.

14. Inability to complete subjective data as required; e.g. on mobile application and
questionnaires

15. Pregnant women (as determined by self-report)

16. Have severe epilepsy

17. Have severe form of cardiovascular disease

18. 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