The Enso Study for Chronic Low Back Pain (EPS)

A Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Enso device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California Medical Center
      • Contact: Bobby Tay, MD; Phone Number: 415-353-2739; Email: TayB@ucsf.edu
      • Contact: Krishn Khanna, MD; Phone Number: 719-510-9613; Email: Krishn.Khanna@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once a week for 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional back pain assessment	Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.	Once a week for 4 weeks

Collaborators and Investigators

• Sponsor: Thimble Bioelectronics, Inc.
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Bobby Tay, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): January 30, 2021

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Protocol 17-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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