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Enso Pilot Study for Chronic Low Back Pain

WithdrawnNot applicableNCT03409783
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 single blind, sham-controlled randomized clinical trial.

Study details

Official title
A Multicenter Randomized Controlled Trial Evaluating the Effectiveness of the Enso Device for Treatment of Chronic Low Back Pain in Relation to Study Entry Criteria
Interventions
Sponsor
Thimble Bioelectronics, Inc.
Collaborators
University of California, San Francisco
Start date
2018-02-14
Primary completion
2018-10-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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: 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…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03409783