Impact of DuoTherm on Opioid Use and Low Back Pain

MMJ Labs

Status: Completed

Conditions: Opioid Use; Low Back Pain

Treatments: Device: M-Stim; Device: TENS

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04491175

R44DA058952 (U.S. NIH Grant/Contract)

4R44DA049631-02 (U.S. NIH Grant/Contract)

Duotherm

Details and patient eligibility

About

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)

Full description

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).

Enrollment: 160 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Multimodal Harmonic Mechanical Stimulation Neuromodulation Wearable Belt (M-Stim)

Experimental group

Description:

DuoTherm is a novel multimodal low back pain relief device incorporating 8 harmonic vibration patterns of mechanical stimulation (M-Stim) including neuromodulatory frequencies, 5 intensity levels, 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 at least daily for 30 minutes.

Treatment:

Device: M-Stim

Transcutaneous Electrical Nerve Stimulation (TENS)

Active Comparator group

Description:

A prescription 4-lead 8-channel TENS unit (LG Smart) with variable intensity settings. Patients will be instructed to use the TENS at least daily for 30 minutes.

Treatment:

Device: TENS