NCT04491175

Impact of DuoTherm on Opioid Use and Low Back Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: MMJ Labs LLC · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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).

Conditions

• Opioid Use
• Low Back Pain

Interventions

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

Timeline

• Start date: 2022-06-23
• Primary completion: 2024-07-09
• Completion: 2025-05-29
• First posted: 2020-07-29
• Last updated: 2025-08-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study