Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-02-14
2018-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
ENSO Device
An active ENSO device that delivers neuromodulation therapy.
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.
Sham Device
Sham Device
Interventions
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ENSO Device
An active ENSO device that delivers neuromodulation therapy.
Sham Device
Sham Device
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Thimble Bioelectronics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bobby Tay, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Spine and Nerve Diagnostic Center
Roseville, California, United States
University of California
San Francisco, California, United States
Countries
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Other Identifiers
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Protocol 17-02
Identifier Type: -
Identifier Source: org_study_id
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