Recruiting

Enso

Sponsor:

Thimble Bioelectronics, Inc.

Code:

NCT03320863

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enso device

Study Details

Brief summary:

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.

Conditions

Chronic Low Back Pain

Study ID

NCT03320863

Start date

Nov 9, 2017

Status verified date

Jan, 2020

Completion date

Jan 30, 2021

Anticipated

Primary completion date

Dec 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

no intervention: 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.

Interventions

Enso device

An active Enso device that delivers neuromodulation therapy.

Primary outcome measure

  • Six Minute Walk Test [ Time Frame: Once a week for 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of California Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

More Information

Sponsor

Thimble Bioelectronics, Inc.

Last update posted

Jan 27, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thimble Bioelectronics, Inc. on 2020-01-27.