Suspended

EPSA Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain

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What is being tested

Enso device

Device
Who is being recruted

Over 18 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2017
See protocol details

Summary

Principal SponsorThimble Bioelectronics, Inc.
Study ContactShaun CEO
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 9, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleA Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain
NCT03320863
Principal SponsorThimble Bioelectronics, Inc.
Study ContactShaun CEO
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

14 inclusion criteria required to participate
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
Show More Criteria
17 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of California Medical Center

San Francisco, United StatesOpen University of California Medical Center in Google Maps
SuspendedOne Study Center