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WithdrawnNCT03409783Updated Nov 23, 2018

Enso Pilot Study for Chronic Low Back Pain

An interventional study of ENSO Device and Sham Device in Chronic Low Back Pain, sponsored by Thimble Bioelectronics, Inc.. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-23.

Sponsored by Thimble Bioelectronics, Inc. · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Decided not to enroll into this study due to costs and other factors
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Low Back Pain
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceENSO Device

    An active ENSO device that delivers neuromodulation therapy.

  • DeviceSham Device

    Sham Device

05

What researchers measure

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.

    Time frame: Once a week for two weeks

Secondary outcomes

  1. Functional back pain assessment

    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

06

Study locations

2 sites
  • Spine and Nerve Diagnostic Center
    Roseville, California 95661, United States
  • University of California
    San Francisco, California 94143, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03409783
Lead sponsor
Thimble Bioelectronics, Inc.
Collaborators
University of California, San Francisco
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Feb 14, 2018
Primary completion
Oct 1, 2018
Completion
Oct 1, 2018
Last update
Nov 23, 2018

Study contacts

Bobby Tay, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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