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Behavioural Intervention

DuoTherm for Chronic Lower Back Pain

N/A

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

Must not have

New neurologic deficits

Contraindication to any medication for pain management that would impact analgesic use record

Timeline

Screening 3 weeks

Treatment Varies

Follow Up difference between first 2 weeks and last 2 weeks over 6 month period

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have new issues with my nerves or brain function.

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I cannot take certain pain medications due to adverse reactions.

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I have skin lesions on my lower back.

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I have nerve damage from diabetes that makes it hard to feel if something is too hot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ difference between first 2 weeks and last 2 weeks over 6 month period

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in opioid use in morphine equivalent doses for prior users

Prolonged opioid use

Total Opioid use in morphine equivalent doses in opioid naive and prior users

Secondary study objectives

Change in 24 hour average pain weekly from initial to final

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity (8a) measures from initial to completion of study

Change in current pain intensity from initial to final

Other study objectives

Duotherm use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met