Enso Pilot Study for Chronic Low Back Pain

• ClinicalTrials.gov Identifier: NCT03409783
• Recruitment Status: Withdrawn
• First Posted: January 24, 2018
• Last Update Posted: November 23, 2018
• Sponsor: Thimble Bioelectronics, Inc.
• Collaborator: University of California, San Francisco
• Information provided by (Responsible Party): Thimble Bioelectronics, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Device: ENSO Device; Device: Sham Device	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single blind, randomized, sham controlled study
• Masking: Single (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.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 14, 2018
• Actual Primary Completion Date: October 1, 2018
• Actual Study Completion Date: October 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active or ENSO Group; 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; An active ENSO device that delivers neuromodulation therapy.
Sham Comparator: Sham Group; 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; Sham Device

Outcome Measures

Primary Outcome Measures :

1. Six Minute Walk Test [ Time Frame: Once a week for two 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.

Secondary Outcome Measures :

1. Functional back pain assessment [ Time Frame: Once a week for two weeks ]
   Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Walk no further than 250 meters during a pre-study administration of the Six Minute Walk Test
2. 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
3. Mechanical (myofascial), axial back pain (focused around the spine)
4. 6/10 or greater level of pain
5. Functionally debilitated by their pain (e.g., difficulty walking)
6. Minimal radicular symptoms with no effect on functionality, medication, quality of life
7. Expressed desire to stop taking pain medications
8. Expressed desire to improve disability
9. 80% or greater of disability is due to pain in the low back (as opposed to other body areas)
10. Experiencing chronic pain for at least 6 months
11. Interested in being active, improving their functionality
12. Comfortable with using technology in daily life
13. Subject able to understand and grant informed consent
14. Documented adherence with clinic follow up visits per medical records
15. Has an email account
16. Above 18 years old

Exclusion Criteria:

1. Patients that do not own or have access to a smartphone
2. 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)
3. Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
4. Primary symptoms due to spinal stenosis
5. Source of back pain related to an acute nerve impingement
6. Diagnosis of cancer/malignant tumors in the last 5 years
7. Source of back pain is an infection
8. Prior spinal fusion surgery
9. Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
10. Has radicular pain symptoms that account for more than 20% of their pain and/or functional impairment
11. Has undergone surgery to solve pain related to the study indication in the past 6 months
12. Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion
13. 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.
14. Inability to complete subjective data as required; e.g. on mobile application and questionnaires
15. Pregnant women (as determined by self-report)
16. Have severe epilepsy
17. Have severe form of cardiovascular disease
18. 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

Contacts and Locations

Locations

United States, California

Spine and Nerve Diagnostic Center

Roseville, California, United States, 95661

University of California

San Francisco, California, United States, 94143

Sponsors and Collaborators

Thimble Bioelectronics, Inc.

University of California, San Francisco

Investigators

• Principal Investigator: Bobby Tay, MD; University of California, San Francisco

More Information

• Responsible Party: Thimble Bioelectronics, Inc.
• ClinicalTrials.gov Identifier: NCT03409783
• Other Study ID Numbers: Protocol 17-02
• First Posted: January 24, 2018
• Last Update Posted: November 23, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations