The Enso Study for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

— EPS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03320863
• Other study ID #: Protocol 17-01
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: January 2020
• Source: Thimble Bioelectronics, Inc.
• Contact: Shaun CEO
• Phone: 408-799-8783
• Email: shaun[@]ensorelief.com
• 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 double-blinded, 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Locations

Country	Name	City	State
United States	University of California Medical Center	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 4 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 4 weeks