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The Enso Study for Chronic Low Back Pain (EPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320863
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Thimble Bioelectronics, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Enso device Not Applicable

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 four 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. Medication usage will also be tracked through the use of CURES 2.0 information and pill counts at specified study visits. Additional functional testing will be conducted at each study visit.

At the 4 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 week in the study, using the active device.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized, sham controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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.
Device: Enso device
An active Enso device that delivers neuromodulation therapy.

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.



Primary Outcome Measures :
  1. Six Minute Walk Test [ Time Frame: Once a week for 4 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 Outcome Measures :
  1. Functional back pain assessment [ Time Frame: Once a week for 4 weeks ]
    Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320863


Contacts
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Contact: Shaun CEO 408-799-8783 shaun@ensorelief.com

Locations
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United States, California
University of California Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Bobby Tay, MD    415-353-2739    TayB@ucsf.edu   
Contact: Krishn Khanna, MD    719-510-9613    Krishn.Khanna@ucsf.edu   
Sponsors and Collaborators
Thimble Bioelectronics, Inc.
University of California, San Francisco
Investigators
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Principal Investigator: Bobby Tay, MD University of California, San Francisco
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Responsible Party: Thimble Bioelectronics, Inc.
ClinicalTrials.gov Identifier: NCT03320863    
Other Study ID Numbers: Protocol 17-01
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms