Enso Pilot Study for Chronic Low Back Pain

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Chronic Low Back Pain

In brief

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.

Key facts

Study ID

NCT03409783

Run by

Thimble Bioelectronics, Inc.

People needed

0

Starts

2018-02-14

Expected to finish

2018-10-01

Last updated by the study team

2018-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spine and Nerve Diagnostic Center — Roseville, California, United States
• University of California — San Francisco, California, United States

Full record on ClinicalTrials.gov

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