NCT04494698

Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain

Addressing Pain and Disability From Low Back Pain With an External Multimodal Neuromodulation Device

• 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 pain and disability change in Low Back Pain with DuoTherm Compared to Active Control

Detailed description

160 patients with moderate to severe acute or exacerbations of chronic low back pain presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or an 8 channel prescription TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

Conditions

• Acute Low-back Pain
• Chronic Low-back Pain
• Pain, Intractable

Interventions

Type	Name	Description
DEVICE	Duotherm VibraCool Back Device	Active New multimodal pain device
DEVICE	TENS 8-channel unit	LG Smart TENS unit

Timeline

• Start date: 2022-06-23
• Primary completion: 2024-07-09
• Completion: 2025-06-24
• First posted: 2020-07-31
• Last updated: 2025-07-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study