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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2017-11-09
2021-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SCS for the Treatment Of Chronic Pain of the Upper Extremities
NCT02703818
An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
NCT02801630
Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain
NCT03658018
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
NCT04873232
Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
NCT07122453
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Enso device
An active Enso device that delivers neuromodulation therapy.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enso device
An active Enso device that delivers neuromodulation therapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Thimble Bioelectronics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bobby Tay, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California Medical Center
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Protocol 17-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.