Enso Pilot Study for Chronic Low Back Pain
a study on Pain
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.
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
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.
Chronic Low Back Pain Back Pain Low Back Pain
You can join if…
Open to people ages 18 years and up
- Walk no further than 250 meters during a pre-study administration of the Six Minute Walk Test
- 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
- 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
You CAN'T join if...
- Patients that do not own or have access to a smartphone
- 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)
- 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
- Prior spinal fusion surgery
- Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
- . Has radicular pain symptoms that account for more than 20% of their pain and/or functional impairment
- . 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
- University of California not yet accepting patients
San Francisco, California, 94143, United States
- Spine and Nerve Diagnostic Center accepting new patients
Roseville, California, 95661, United States
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03409783.