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

Sponsor

MMJ Labs LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT04494841

Collaborator

Sport and Spine Rehab Clinical Research Foundation (Other)

Enrollment

Location

Arm

13.1

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Low Back Sprain Low Back Pain, Recurrent	Device: Duotherm VibraCool Back Device	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Jan 17, 2020

Actual Primary Completion Date :

Jan 20, 2021

Actual Study Completion Date :

Feb 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DuoTherm VibraCool Back Device 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.	Device: Duotherm VibraCool Back Device Low back plate belt with mechanicothermal and pressure intervention options.

Arm

Intervention/Treatment

Experimental: DuoTherm VibraCool Back Device

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.

Device: Duotherm VibraCool Back Device

Low back plate belt with mechanicothermal and pressure intervention options.

Outcome Measures

Primary Outcome Measures

Change in pain: 10cm Visual Analog Scale (VAS) printed on paper from 0 (no pain) to 10 (most pain) [30 minutes]
Difference between initial VAS and VAS after use of device
Participants' choice in thermal options [30 minutes]
One of four options: hot, cold, none, both
Would you recommend [After 30 minutes]
Binary approval or disapproval of device

Secondary Outcome Measures

Subjective pain relief [30 minutes]
7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sport and Spine Rehab Clinic	Rockville	Maryland	United States	20852

Sponsors and Collaborators

MMJ Labs LLC
Sport and Spine Rehab Clinical Research Foundation

Investigators

Principal Investigator: Amy Baxter, MD, MMJ Labs LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Amy Lynn Baxter, Principal Investigator, MMJ Labs LLC

ClinicalTrials.gov Identifier:

NCT04494841

Other Study ID Numbers:

UsabilityDuoTherm

First Posted:

Jul 31, 2020

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Amy Lynn Baxter, Principal Investigator, MMJ Labs LLC

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Mar 17, 2021