An interventional study of ENSO Device and Sham Device in Chronic Low Back Pain, sponsored by Thimble Bioelectronics, Inc.. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-23.
Sponsored by Thimble Bioelectronics, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Active ENSO device use for two weeks, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
Device: ENSO Device
Sham device use for two weeks, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
Device: Sham Device
An active ENSO device that delivers neuromodulation therapy.
Sham Device
Six Minute Walk Test
Compare the change in patient's 6 Minute Walk Test (6MWT) between the Enso intervention group and the sham group using the validated 6MWT procedure.
Time frame: Once a week for two weeks
Functional back pain assessment
Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.
Time frame: Once a week for two weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Thimble Bioelectronics, Inc.