Clinical trial NCT04491175: Impact of DuoTherm on Acute Opioid Use and Low Back Pain
Official title: Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Clinical Evaluation of DuoTherm vs. TENS for Opioid-Sparing in Moderate to Severe Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Low Back Pain
Keywords: pain
analgesia
medical device
opioid
Lead sponsor: MMJ Labs LLC
Sponsor class: INDUSTRY
Collaborators: name: Sport and Spine Rehab Clinical Research Foundation
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-07-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind controlled trial with 3- (aLBP) or 6- month (cLPB) follow-up.
Primary purpose: PREVENTION

Brief summary: Evaluate the change in opioid use in patients with moderate to severe low back pain when dispensed a multimodal DuoTherm mechanical stimulation (M-Stim) unit compared to TENS Transcutaneous Electrical Nerve Stimulation.

Detailed description: 160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be stratified by opioid use status (naive or prior use for LBP) and randomized to one of two conditions: an M-Stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead 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 opioid brand, dose, pill number, and source, and pain data.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-90 presenting for treatment of acute low back pain or acute exacerbation of chronic LBP; pain duration \<3 months not on chronic opioids, chronic opioids permitted for chronic pain \>=3 months; self-report NRS measures \>=4, capacity to understand all relevant risks and potential benefits of the study (informed consent); willingness to communicate information on opioid use including prescription formulation, pill #, dose, and source.

Exclusion Criteria:

* Opioid prescription in the past month; Radicular pain likely reflecting a surgical or mechanical problem; BMI greater than 50 (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.

Primary outcomes:
measure: Opioid use in milligram morphine equivalents (MME)
timeFrame: 1 month (duration of daily recording)
measure: Opioid initiation in the opioid-naive
timeFrame: All opioid diaries for 3 months
Secondary outcomes:
measure: Opioid Use Risk Factors in the Opioid-Naive
timeFrame: All opioid diaries for 3 months
measure: Opioid use in those with more severe pain
timeFrame: All opioid diaries for 3 months
measure: Opioid prescribing after receiving a pain relief device compared to a contemporaneous LPB prescribing of 25%
timeFrame: All opioid diaries for 3 months
Other outcomes:
Locations:
city: Landover
country: United States
facility: Sport and Spine Rehab Clinics
state: Maryland
city: Fairfax
country: United States
facility: Kaizo Health Fairfax
state: Virginia
Study officials:
affiliation: Sport and Spine Clinical Research Foundation
name: Jena Slaski
role: STUDY_DIRECTOR
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