Enso Pilot Study for Chronic Low Back Pain

NCT03409783 | Withdrawn FDA Device

• 1 other identifier: Protocol 17-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 two weeks

Secondary Outcomes (1)

• Functional back pain assessment

  Once a week for two weeks

Study Arms (2)

Active or ENSO Group

ACTIVE COMPARATOR

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

Sham Group

SHAM COMPARATOR

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

Interventions

ENSO Device DEVICE

An active ENSO device that delivers neuromodulation therapy.

Active or ENSO Group

Sham Device DEVICE

Sham Device

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• /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
• % 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thimble Bioelectronics, Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (2)

Spine and Nerve Diagnostic Center

Roseville, California, 95661, United States

Location

University of California

San Francisco, California, 94143, United States

Location

Study Officials

• Bobby Tay, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single blind, randomized, sham controlled study

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 24, 2018
• Study Start: February 14, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)