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

October 20, 2022 updated by: Amy Lynn Baxter, MMJ Labs LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Sport and Spine Rehab Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain: Visual Analog Scale (VAS)
Time Frame: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.
Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
Participants' Choice in Thermal Options
Time Frame: 30 minutes
One of four options: hot, cold, none, both
30 minutes
Would You Recommend
Time Frame: After 30 minutes
Binary approval or disapproval of device
After 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Pain Relief
Time Frame: 30 minutes
7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MMJ Labs LLC

Collaborators

National Institute on Drug Abuse (NIDA)
Sport and Spine Rehab Clinical Research Foundation

Investigators

  • Principal Investigator: Amy Baxter, MD, MMJ Labs LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2020

Primary Completion (Actual)

January 20, 2021

Study Completion (Actual)

February 18, 2021

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

36 months after publication

IPD Sharing Access Criteria

researchers providing approved methodologically sound proposals

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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