Chronic Low Back Pain
Conditions
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 single blind, 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 sham device and will be instructed to self-administer treatment daily for one hour or more per day for two weeks in both cohorts. Throughout the duration of the study, data will be recorded via a smartphone application regarding treatment usage and intensity, pain levels, the subject's impression of any changes in their functionality, and their opioid and non-opioid medication intake. Additional functional testing will be conducted at each study visit. At the 2 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 2 week period using the active device.
Interventions
DEVICEENSO Device
An active ENSO device that delivers neuromodulation therapy.
DEVICESham Device
Sham Device
Sponsors
University of California, San Francisco
Thimble Bioelectronics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Devices are assigned per the randomization schedule, with the sham device identical to the active device in every way except that no neuromodulation is delivered. The neuromodulation that the active device delivers can be done in a way that causes no sensation, so subjects are not unmasked.
Intervention model description
Single blind, randomized, sham controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test | Once a week for two weeks | Compare the change in patient's 6 Minute Walk Test (6MWT) between the Enso intervention group and the sham group using the validated 6MWT procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional back pain assessment | Once a week for two weeks | Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT. |
Countries
United States
Outcome results
None listed