Enso Pilot Study for Chronic Low Back Pain

Status Withdrawn

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 single blind, 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03409783
Study type	Interventional
Source	Thimble Bioelectronics, Inc.
Contact
Status	Withdrawn
Phase	N/A
Start date	February 14, 2018
Completion date	October 1, 2018

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