Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

February 5, 2024 updated by: Amy Lynn Baxter, MMJ Labs LLC

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 an 8 channel TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Landover, Maryland, United States, 20785
        • Sport and Spine Rehab Clinics
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Sport and Spine Rehab Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • Buzzy
  • Vibracool plus heat or pressure
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Opioid use in morphine equivalent doses
Time Frame: 6 months
Daily diary of analgesic use and dose
6 months
Change in opioid use in morphine equivalent doses
Time Frame: Difference between first 2 weeks and last 2 weeks over 6 month period
Daily diary of analgesic use and dose
Difference between first 2 weeks and last 2 weeks over 6 month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in current weekly pain from initial to final
Time Frame: 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
Weekly for 3 weeks, then monthly at 1,3, and 6 months
Change in 24 hour average pain weekly from initial to final
Time Frame: 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
Weekly for 3 weeks, then monthly at 1,3, and 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain measures from initial to completion of study
Time Frame: 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).
Initial, 1 month, 3 months, completed at the end of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duotherm use
Time Frame: 6 months
Daily diary of study device or TENS unit
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MMJ Labs LLC

Collaborators

National Institute on Drug Abuse (NIDA)
Sport and Spine Rehab Clinical Research Foundation

Investigators

  • Principal Investigator: Amy Baxter, MD, Pain Care Labs (a dba of MMJ Labs)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Estimated)

June 29, 2024

Study Completion (Estimated)

July 29, 2024

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DuoThermChronic
  • 4R44DA049631 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

up to 36 months after publication of results

IPD Sharing Access Criteria

researchers providing approved methodologically sound proposals or requests

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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