Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

Sponsor

MMJ Labs LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04494698

Collaborator

Sport and Spine Rehab Clinical Research Foundation (Other)

100

Enrollment

Locations

Arms

9.2

Anticipated Duration (Months)

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate opioid use and pain change in chronic Low Back Pain with DuoTherm Compared to Sham

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder Chronic Low-back Pain Opioid Use Opioid Dependence	Device: Duotherm VibraCool Back Device Device: TENS 8-channel unit	N/A

Detailed Description

100 patients with chronic low back pain presenting for chiropractic and rehabilitation care will be stratified by gender and randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or a sham "posture plate" with a sculpted metal plate on a belt but no active heat, cold, pressure, or vibration. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

Participants will be instructed that there are interventions being evaluated for low back pain and the impact of the medical device on medication use and pain, and that they will be self-assessing pain and use of prescribed and over the counter medications. Study staff will train them on the device or TENS unit via an online video they will access in clinic, but care providers will not be informed of the study arm. An assessment for blinding will be adminstered at the end of the data collection for care providers and participants.

Primary Purpose:

Treatment

Official Title:

Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Clinical Evaluation of DuoTherm for Opioid-Sparing in Chronic Low Back Pain

Actual Study Start Date :

Jun 23, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DuoTherm VibraCool Back Device A low back pain relief device incorporating multiple speeds and patterns of vibration and optional heat, cold, or pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device twice daily for 20 minutes.	Device: Duotherm VibraCool Back Device Active New multimodal pain device Other Names: Vibracool plus heat or pressure Buzzy
Active Comparator: Multimodal TENS Unit LG SMART TENS stimulator is a portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.	Device: TENS 8-channel unit LG Smart TENS unit

Arm

Intervention/Treatment

Active Comparator: DuoTherm VibraCool Back Device

A low back pain relief device incorporating multiple speeds and patterns of vibration and optional heat, cold, or pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device twice daily for 20 minutes.

Device: Duotherm VibraCool Back Device

Active New multimodal pain device

Other Names:

Vibracool plus heat or pressure

Buzzy

Active Comparator: Multimodal TENS Unit

LG SMART TENS stimulator is a portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.

Device: TENS 8-channel unit

LG Smart TENS unit

Outcome Measures

Primary Outcome Measures

Total Opioid use in morphine equivalent doses [6 months]
Daily diary of analgesic use and dose
Change in opioid use in morphine equivalent doses [Difference between first 2 weeks and last 2 weeks over 6 month period]
Daily diary of analgesic use and dose

Secondary Outcome Measures

Change in current weekly pain from initial to final [Weekly for 3 weeks, then monthly at 1,3, and 6 months]
Self-rated current pain on Numeric Rating Scale with 0 no pain and 11 maximum pain
Change in 24 hour average pain weekly from initial to final [Weekly for 3 weeks, then monthly at 1,3, and 6 months]
Self-rated pain over past 24 hours on Numeric Rating Scale with 0 no pain and 11 maximum pain
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain measures from initial to completion of study [Initial, 1 month, 3 months, completed at the end of 6 months]
Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest), Pain Intensity (2 questions, yielding possible scores of 2(low) and 10 (highest), and Depression scores (4 questions, yielding possible scores of 4(low) and 20 (most depressed).

Other Outcome Measures

Duotherm use [6 months]
Daily diary of study device or TENS unit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with chronic low back pain by clinician
Pain duration >3 months with or without opioid prescription for this exacerbation
Self-report NRS measures >4
Capacity to understand all relevant risks and potential benefits of the study (informed consent)
Willingness to communicate information on prescription pill # and dose, or dose and pill type if medication is prescribed by someone else.

Exclusion Criteria:

Pacemaker
Radicular pain likely reflecting a surgical or mechanical problem
BMI greater than 30 (device won't fit)
Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
Diabetic neuropathy rendering a patient unable to determine if the device is too hot
New neurologic deficits
Skin lesions over the low back area
Contraindication to any medication for pain management that would impact analgesic use record
Inability to apply DuoTherm or Sham Device