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The Enso Study for Chronic Low Back Pain (EPS)

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enso device
Sponsored by
Thimble Bioelectronics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Mechanical (myofascial), axial back pain (focused around the spine)
  2. 6/10 or greater level of pain
  3. Functionally debilitated by their pain (e.g., difficulty walking)
  4. Minimal radicular symptoms with no effect on functionality, medication, quality of life
  5. Expressed desire to stop taking pain medications
  6. Expressed desire to improve disability
  7. 80% or greater of disability is due to pain in the low back (as opposed to other body areas)
  8. Experiencing chronic pain for at least 6 months
  9. Interested in being active, improving their functionality
  10. Comfortable with using technology in daily life
  11. Subject able to understand and grant informed consent
  12. Documented adherence with clinic follow up visits per medical records
  13. Has an email account
  14. Above 18 years old

Exclusion Criteria:

  1. Patients that do not own or have access to a smartphone
  2. Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
  3. Primary symptoms due to spinal stenosis
  4. Source of back pain related to an acute nerve impingement
  5. Diagnosis of cancer/malignant tumors in the last 5 years
  6. Source of back pain is an infection
  7. Source of pain is a prior spinal fusion surgery
  8. Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
  9. Has radicular pain symptoms that affect functionality, quality of life or medication intake
  10. Has undergone surgery to solve pain related to the study indication in the past 6 months
  11. Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion
  12. Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in the judgement of the investigator
  13. Inability to complete subjective data as required; e.g. on mobile application and questionnaires
  14. Pregnant women (as determined by self-report)
  15. Have severe epilepsy
  16. Have severe form of cardiovascular disease
  17. Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes

Sites / Locations

  • University of California Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Active or Enso Group

Sham Group

Arm Description

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.

Sham device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional back pain assessment
Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.

Full Information

First Posted
October 17, 2017
Last Updated
January 22, 2020
Sponsor
Thimble Bioelectronics, Inc.
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03320863
Brief Title
The Enso Study for Chronic Low Back Pain
Acronym
EPS
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
January 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thimble Bioelectronics, Inc.
Collaborators
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, sham controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active or Enso Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Group
Arm Type
No Intervention
Arm Description
Sham device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
Intervention Type
Device
Intervention Name(s)
Enso device
Intervention Description
An active Enso device that delivers neuromodulation therapy.
Primary Outcome Measure Information:
Title
Six Minute Walk Test
Description
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 4 weeks
Secondary Outcome Measure Information:
Title
Functional back pain assessment
Description
Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.
Time Frame
Once a week for 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Expressed desire to stop taking pain medications Expressed desire to improve disability 80% or greater of disability is due to pain in the low back (as opposed to other body areas) Experiencing chronic pain for at least 6 months Interested in being active, improving their functionality Comfortable with using technology in daily life Subject able to understand and grant informed consent Documented adherence with clinic follow up visits per medical records Has an email account Above 18 years old Exclusion Criteria: 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 Diagnosis of cancer/malignant tumors in the last 5 years Source of back pain is an infection Source of pain is a prior spinal fusion surgery Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device Has radicular pain symptoms that affect functionality, quality of life or medication intake Has undergone surgery to solve pain related to the study indication in the past 6 months Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in the judgement of the investigator Inability to complete subjective data as required; e.g. on mobile application and questionnaires Pregnant women (as determined by self-report) Have severe epilepsy Have severe form of cardiovascular disease Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaun CEO
Phone
408-799-8783
Email
shaun@ensorelief.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobby Tay, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobby Tay, MD
Phone
415-353-2739
Email
TayB@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Krishn Khanna, MD
Phone
719-510-9613
Email
Krishn.Khanna@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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The Enso Study for Chronic Low Back Pain

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