Enso Pilot Study for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03409783
• Other study ID #: Protocol 17-02
• Status: Withdrawn
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2018
• Source: Thimble Bioelectronics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• ENSO Device
An active ENSO device that delivers neuromodulation therapy.
• Sham Device
Sham Device

Locations

Country	Name	City	State
United States	Spine and Nerve Diagnostic Center	Roseville	California
United States	University of California	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Thimble Bioelectronics, Inc.	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six Minute Walk Test	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.	Once a week for two weeks
Secondary	Functional back pain assessment	Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.	Once a week for two weeks