Status:
UNKNOWN
The Enso Study for Chronic Low Back Pain
Lead Sponsor:
Thimble Bioelectronics, Inc.
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Fifty subjects will be selected based on the inclusion criteria and then randomized to either the intervention group or the sham control group. Each subject will be randomly fitted with an Enso or a s...
Eligibility Criteria
Inclusion
- Mechanical (myofascial), axial back pain (focused around the spine)
- 6/10 or greater level of pain
- Functionally debilitated by their pain (e.g., difficulty walking)
- Minimal radicular symptoms with no effect on functionality, medication, quality of life
- Expressed desire to stop taking pain medications
- Expressed desire to improve disability
- 80% or greater of disability is due to pain in the low back (as opposed to other body areas)
- Experiencing chronic pain for at least 6 months
- Interested in being active, improving their functionality
- Comfortable with using technology in daily life
- Subject able to understand and grant informed consent
- Documented adherence with clinic follow up visits per medical records
- Has an email account
- Above 18 years old
Exclusion
- Patients that do not own or have access to a smartphone
- Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
- Primary symptoms due to spinal stenosis
- Source of back pain related to an acute nerve impingement
- Diagnosis of cancer/malignant tumors in the last 5 years
- Source of back pain is an infection
- Source of pain is a prior spinal fusion surgery
- Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
- Has radicular pain symptoms that affect functionality, quality of life or medication intake
- Has undergone surgery to solve pain related to the study indication in the past 6 months
- Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion
- 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
- Inability to complete subjective data as required; e.g. on mobile application and questionnaires
- Pregnant women (as determined by self-report)
- Have severe epilepsy
- Have severe form of cardiovascular disease
- 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
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03320863
Start Date
November 9 2017
End Date
January 30 2021
Last Update
January 27 2020
Active Locations (1)
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1
University of California Medical Center
San Francisco, California, United States, 94143