Impact of DuoTherm on Acute Opioid Use and Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain; Opioid Use
• Interventions: Device: DuoTherm; Device: TENS

• Registration Number: NCT04491175
• Lead Sponsor: MMJ Labs LLC

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.

Study Timeline

• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-29
• Study Start: 2022-06-23
• Primary Completion: 2024-01-31
• Study Completion: 2024-07-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DuoTherm	DuoTherm	A low back pain relief device incorporating 8 harmonic patterns of mechanical stimulation (vibration) capable of neuromodulatory nociceptor block and vasodilation, 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.
Multimodal TENS	TENS	An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes.

Primary Outcome Measures

Name	Time	Method
Opioid use in milligram morphine equivalents (MME)	1 month (duration of daily recording)	Opioid use in MME would be 30% lower in the M-Stim group compared to TENS for those who take opioids
Opioid initiation in the opioid-naive	All opioid diaries for 3 months	Opioids prescribed for this low back pain event to subjects without history of opioids for LBP will be 30% lower for those in the M-Stim group compared to TENS

Secondary Outcome Measures

Name	Time	Method
Opioid Use Risk Factors in the Opioid-Naive	All opioid diaries for 3 months	Opioid use days, MME, and use after 7 days
Opioid use in those with more severe pain	All opioid diaries for 3 months	Opioid use in those with the NIH Research Taskforce severity of moderate to severe will have lower opioid use days in M-Stim versus TENS
Opioid prescribing after receiving a pain relief device compared to a contemporaneous LPB prescribing of 25%	All opioid diaries for 3 months	Comparison of the relative risk of opioid prescribing for either intervention compared to nationally prevalent prescribing rates of 25% with moderate to severe pain in outpatient settings

Trial Locations

Locations (2)

Sport and Spine Rehab Clinics; 🇺🇸 Landover, Maryland, United States

Kaizo Health Fairfax; 🇺🇸 Fairfax, Virginia, United States