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Enso Pilot Study for Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ENSO Device

Sham Device

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:

Walk no further than 250 meters during a pre-study administration of the Six Minute Walk Test
Confirm that either they are able on their own to place the device (i.e., the gel pad) in its proper location, or they have a caretaker or family member who can assist them if needed
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
Subject who, in the Investigator's opinion, does not demonstrate a strong desire to reduce opioid or other pain medication usage (e.g., opioid dependence)
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
Prior spinal fusion surgery
Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
Has radicular pain symptoms that account for more than 20% of their pain and/or functional impairment
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

Sites / Locations

Spine and Nerve Diagnostic Center
University of California

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active or ENSO Group

Sham Group

Arm Description

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.

Sham device use for two weeks, 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

NCT ID

NCT03409783

First Posted

January 18, 2018

Last Updated

November 20, 2018

Sponsor

Thimble Bioelectronics, Inc.

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT03409783

Brief Title

Enso Pilot Study for Chronic Low Back Pain

Official Title

A Multicenter Randomized Controlled Trial Evaluating the Effectiveness of the Enso Device for Treatment of Chronic Low Back Pain in Relation to Study Entry Criteria

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Decided not to enroll into this study due to costs and other factors

Study Start Date

February 14, 2018 (Actual)

Primary Completion Date

October 1, 2018 (Actual)

Study Completion Date

October 1, 2018 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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 single blind, 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 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.

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

Single blind, randomized, sham controlled study

Masking

Participant

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

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active or ENSO Group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Sham Group

Arm Type

Sham Comparator

Arm Description

Sham device use for two weeks, 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.

Intervention Type

Device

Intervention Name(s)

Sham Device

Intervention Description

Sham Device

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 two 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 two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Walk no further than 250 meters during a pre-study administration of the Six Minute Walk Test Confirm that either they are able on their own to place the device (i.e., the gel pad) in its proper location, or they have a caretaker or family member who can assist them if needed 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 Subject who, in the Investigator's opinion, does not demonstrate a strong desire to reduce opioid or other pain medication usage (e.g., opioid dependence) 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 Prior spinal fusion surgery Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device Has radicular pain symptoms that account for more than 20% of their pain and/or functional impairment 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

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

Spine and Nerve Diagnostic Center

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

University of California

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Enso Pilot Study for Chronic Low Back Pain

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