Impact of DuoTherm on Acute Opioid Use and Low Back Pain

Study Overview
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Brief Summary
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Evaluate opioid use and pain change in acute Low Back Pain with DuoTherm Compared to TENS Therapy Unit

Detailed Description
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60 patients with acute 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 a TENS unit with 8 channels of stimulation and adjustable intensity. 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 Acute Low Back Pain

Conditions
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Opioid Use, Low Back Pain

Intervention / Treatment
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* Device: DuoTherm
* Device: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-90 diagnosed with acute low back pain by clinician; pain duration <3 months 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: Opioid prescription in the past month; 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; a contraindication to any medication for pain management that would impact analgesic use record; inability to apply DuoTherm or TENS device; pacemaker that would render patients unable to use the TENS 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DuoTherm<br>A low back pain relief device incorporating multiple speeds of vibration and optional heat, cold, and 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 a day for 20 minutes. | Device: DuoTherm<br>* New combination device comprising a sculpted low back plate with multiple sensory modalities held in place with a neoprene belt capable of being tightened with patient control of variations in sensory modalities.<br>* Other names: VibraCool plus heat and pressure;|
| Active Comparator: Multimodal TENS<br>An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes. | Device: TENS<br>* LG SMART TENS stimulator is a portable electgrotherapy devcie featuring transcutaneous electrical nerve stimulation (TENS) therapeitud devcie, 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.<br>* Other names: LG Smart TENS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use in morphine equivalent doses | Daily diary of analgesic use and dose | 3 months | 
| Opioid initiation | Use of any opioids, prescribed or borrowed | initial 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in current weekly pain from initial to resolution | Self-rated current pain on 0-11 NRS | 3 months | 
| Change in 24 hour average pain weekly from initial to resolution | Self-rated average pain over past 24 hours on 0-11 NRS | 3 months | 
| Change in PROMIS Pain Interference measure from initial to completion of study | Change in Monthly Pain Interference score | Initial to end of 3 months | 
| Change in PROMIS Pain Intensity measure from initial to completion of study | Change in Monthly Pain Intensity score | Initial to end of 3 months | 
| Change in PROMIS Depression measures from initial to completion of study | Change in Monthly Depression score | Initial to end of 3 months | 

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