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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

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.

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 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
2,503 Previous Clinical Trials
2,625,483 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
~32 spots leftby Jul 2025
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