NCT04494841

Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

Addressing Feasibility of the DuoTherm in Acute and Chronic Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: MMJ Labs LLC · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.

Detailed description

To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.

Conditions

• Low Back Pain
• Low Back Sprain
• Low Back Pain, Recurrent

Interventions

Type	Name	Description
DEVICE	Duotherm VibraCool Back Device	Low back plate belt with mechanicothermal and pressure intervention options.

Timeline

• Start date: 2020-01-17
• Primary completion: 2021-01-20
• Completion: 2021-02-18
• First posted: 2020-07-31
• Last updated: 2022-10-21
• Results posted: 2022-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study