Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

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

Detailed Description
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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.

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

Conditions
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Opioid-use Disorder, Chronic Low-back Pain, Opioid Use, Opioid Dependence

Intervention / Treatment
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* Device: Duotherm VibraCool Back Device
* Device: TENS 8-channel unit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DuoTherm VibraCool Back Device<br>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<br>* Active New multimodal pain device<br>* Other names: Buzzy;|
| Active Comparator: Multimodal TENS Unit<br>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<br>* LG Smart TENS unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid use in morphine equivalent doses | Daily diary of analgesic use and dose | 6 months | 
| Change in opioid use in morphine equivalent doses | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid use, pain, medical device, analgesia, vibration, thermal, Buzzy