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

M

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)

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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