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The Enso Study for Chronic Low Back Pain — EPS  

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03320863
Study type Interventional
Source Thimble Bioelectronics, Inc.
Contact Shaun CEO
Phone 408-799-8783
Email shaun@ensorelief.com
Status Recruiting
Phase N/A
Start date November 9, 2017
Completion date January 30, 2021
View Details
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