The Enso Study for Chronic Low Back Pain (EPS)
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|ClinicalTrials.gov Identifier: NCT03320863|
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Device: Enso device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind, randomized, sham controlled study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Devices are assigned per the randomization schedule, with the sham device identical to the active device in every way except that no neuromodulation is delivered. The neuromodulation that the active device delivers can be done in a way that causes no sensation, so subjects are not unmasked.|
|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|
|Actual Study Start Date :||November 9, 2017|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||January 30, 2021|
Active Comparator: Active or Enso Group
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.
Device: Enso device
An active Enso device that delivers neuromodulation therapy.
No Intervention: Sham Group
Sham device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
- Six Minute Walk Test [ Time Frame: Once a week for 4 weeks ]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.
- Functional back pain assessment [ Time Frame: Once a week for 4 weeks ]Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320863
|Contact: Shaun CEOemail@example.com|
|Principal Investigator:||Bobby Tay, MD||University of California, San Francisco|