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

MMJ Labs

Status: Completed

Conditions: Low Back Sprain; Low Back Pain, Recurrent; Low Back Pain

Treatments: Device: Duotherm VibraCool Back Device

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04494841

UsabilityDuoTherm

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute or chronic low back pain as chief complaint
• Capacity to understand all relevant risks and potential benefits of the study (informed consent);
• Willingness to communicate information

Exclusion criteria

• Radicular pain likely reflecting a surgical or mechanical problem
• BMI greater than 30 (device won't fit)
• Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
• Diabetic neuropathy rendering a patient unable to determine if the device is too hot
• New neurologic deficits
• Skin lesions over the low back area
• Contraindication to any medication for pain management that would impact analgesic use record
• Inability to apply DuoTherm

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

DuoTherm VibraCool Back Device

Experimental group

Description:

Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.

Treatment:

Device: Duotherm VibraCool Back Device