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Behavioural Intervention

Multimodal TENS Unit for Opioid Use Disorder

Waitlist Available
Led By Amy Baxter, MD
Research Sponsored by MMJ Labs LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up difference between first 2 weeks and last 2 weeks over 6 month period
Awards & highlights

Study Summary

This trial is looking at whether the use of opioids to treat chronic low back pain is effective, and if so, whether a particular type of opioid, DuoTherm, is more effective than a placebo.

Who is the study for?
This trial is for adults with chronic low back pain who have been experiencing pain for over 3 months and may be using opioids. They must understand the study's risks and benefits, agree to share details about their opioid use if applicable, and not have a BMI over 30 or conditions like pacemakers, sensitivity to cold/vibration, diabetic neuropathy that affects skin sensation, or skin issues on the lower back.Check my eligibility
What is being tested?
The study tests the DuoTherm VibraCool Back Device against a TENS unit to see which one better reduces opioid use and eases chronic low back pain. Participants will report changes in their pain levels and any adjustments in their opioid usage during the trial.See study design
What are the potential side effects?
Potential side effects could include discomfort from device application such as irritation where it touches the skin or an adverse reaction to cold or vibration from DuoTherm for those sensitive to these sensations.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~difference between first 2 weeks and last 2 weeks over 6 month period
This trial's timeline: 3 weeks for screening, Varies for treatment, and difference between first 2 weeks and last 2 weeks over 6 month period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in opioid use in morphine equivalent doses
Total Opioid use in morphine equivalent doses
Secondary outcome measures
Change in 24 hour average pain weekly from initial to final
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain measures from initial to completion of study
Change in current weekly pain from initial to final
Other outcome measures
Duotherm use

Trial Design

2Treatment groups
Active Control
Group I: Multimodal TENS UnitActive Control1 Intervention
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.
Group II: DuoTherm VibraCool Back DeviceActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,493 Total Patients Enrolled
Sport and Spine Rehab Clinical Research FoundationOTHER
19 Previous Clinical Trials
772 Total Patients Enrolled
MMJ Labs LLCLead Sponsor
3 Previous Clinical Trials
425 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify for this research endeavor?

"This medical trial is looking for 100 individuals with chronic lower back pain, ranging from 18 to 90 in age. To be eligible, applicants must have been diagnosed by a healthcare professional, report moderate or higher levels of discomfort on the NRS scale, be willing to share information about their prescribed medication (or someone else's if applicable), had symptoms lasting more than three months and are able understand the study's risks and benefits before signing an informed consent form."

Answered by AI

Are any geriatric patients eligible to participate in this investigation?

"The lower bound for this medical trial is 18 years old and the upper limit is 90."

Answered by AI

What is the total count of participants involved in this experiment?

"Affirmative. According to the information hosted by clinicaltrials.gov, this research is actively seeking participants; it was initially posted on June 23rd 2022 and updated most recently in October 19th 2022. The experiment necessitates 100 individuals from 3 separate sites for completion."

Answered by AI

Does this trial still have vacancies for volunteers?

"Examining the data on clinicaltrials.gov, this scientific research is recruiting participants at present time. Initially posted in June of 2022, it has seen its most recent edit take place in October of the same year."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Sport and Spine Rehab Clinics
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
Recent research and studies
~8 spots leftby Jun 2024