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OpenTrials
Completed

NCT Number: NCT04491175

Impact of DuoTherm on Opioid Use and Low Back Pain

Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)

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Key information

Conditions

Opioid Use Agnosia Back Pain Chronic Pain Low Back Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sport and Spine Rehab Clinics, Landover, Maryland, United States

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About this study

160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be 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 blinded to the hypothesis-driving intervention. They will be prompted daily by a Qualtrics text link to a secure data recording site collecting analgesic use and treatments, including opioid brand, dose, pill number, and source, and pain data, then weekly for 3 months (acute pain) or 6 months (chronic).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age18-90
  • Moderate-to-severe low back pain with numeric rating scale >=4/10
  • Capacity to understand informed consent
  • Willingness to communicate prescriptions, pill number, dose, and source of opioids used

Exclusion criteria

  • Opioid prescription in the past month for acute LBP (new pain <3 months)
  • Radicular pain
  • BMI greater than 50 (device won't fit)
  • Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
  • Diabetic neuropathy
  • New neurologic deficits
  • Skin lesions over the low back area
  • Contraindication to any medication for pain management
  • Inability to apply DuoTherm or TENS device
  • Pacemaker

Treatment and study plan

M-Stim

Device

The casing for the device is a 54" belt with 3-button haptic controller for on-off, therapy cycles(8) and intensity(5) levels.

Other names: DuoTherm, Multiple VibraCool M-Stim units in a harmonic array on a thermoconductive plate with optional cold, heat, and pressure

TENS

Device

LG SMART TENS stimulator is a portable electrotherapy devcie 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.

Other names: LG Smart TENS

Primary outcomes

  1. Opioid initiation in the opioid-naive

    Time frame: All opioid diaries for 3 months

    New opioid prescriptions for subjects without history of opioids for LBP

  2. Opioid use in prior users

    Time frame: 28 days (duration of daily recording)

    Change in milligram morphine equivalents (MME) reported daily

Secondary outcomes

  1. Opioid Use Risk Factors in the Opioid-Naive

    Time frame: All opioid diaries for 3 months

    The difference in opioid use days, MME, and those using opioids more than 7 days after presentation

  2. Opioid use in those with more severe pain

    Time frame: All opioid diaries for 6 months

    Opioid use days in those with the NIH Research Taskforce severity of moderate to severe in M-Stim versus TENS

  3. Opioid prescribing compared to a contemporaneous national LPB prescribing of 25%

    Time frame: All opioid diaries for 6 months

    New opioid prescription rate for each intervention compared to nationally prevalent prescribing rates of 25% with moderate to severe pain in outpatient settings

Sponsors and collaborators

Lead sponsor

MMJ Labs LLC

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Sport and Spine Rehab Clinical Research Foundation

Registry information

Official study title

Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing Pain Relief in Acute and Chronic Low Back Pain

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 29, 2020
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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