The Enso Study for Chronic Low Back Pain
Unknown statusNot applicableNCT03320863
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Enso is a portable device for the treatment of chronic and acute types of musculoskeletal pain. This study is being designed as a double-blinded, sham-controlled randomized clinical trial.
Study details
- Official title
- A Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain
- Conditions
- Interventions
- Device: Enso device
- Sponsor
- Thimble Bioelectronics, Inc.
- Collaborators
- University of California, San Francisco
- Start date
- 2017-11-09
- Primary completion
- 2020-12-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Mechanical (myofascial), axial back pain (focused around the spine) 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: 1. Patients that do not own or have access to a smartphone 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03320863