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Impact of DuoTherm on Acute Opioid Use and Low Back Pain

Primary Purpose

Opioid Use, Low Back Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DuoTherm

TENS

About this trial

This is an interventional prevention trial for Opioid Use focused on measuring pain, analgesia, medical device, opioid

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, aged 18-90 diagnosed with acute low back pain by clinician; pain duration <3 months without opioid prescription for this exacerbation; self-report NRS measures >4, Capacity to understand all relevant risks and potential benefits of the study (informed consent); willingness to communicate information on prescription pill # and dose, or dose and pill type if medication is prescribed by someone else.

Exclusion Criteria:

Opioid prescription in the past month; 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; a contraindication to any medication for pain management that would impact analgesic use record; inability to apply DuoTherm or TENS device; pacemaker that would render patients unable to use the TENS device.

Sites / Locations

Sport and Spine Rehab ClinicsRecruiting
Kaizo Health FairfaxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

DuoTherm

Multimodal TENS

Arm Description

A low back pain relief device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device twice a day for 20 minutes.

An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes.

Outcomes

Primary Outcome Measures

Opioid use in morphine equivalent doses

Daily diary of analgesic use and dose

Opioid initiation

Use of any opioids, prescribed or borrowed

Secondary Outcome Measures

Change in current weekly pain from initial to resolution

Self-rated current pain on 0-11 NRS

Change in 24 hour average pain weekly from initial to resolution

Self-rated average pain over past 24 hours on 0-11 NRS

Change in PROMIS Pain Interference measure from initial to completion of study

Change in Monthly Pain Interference score

Change in PROMIS Pain Intensity measure from initial to completion of study

Change in Monthly Pain Intensity score

Change in PROMIS Depression measures from initial to completion of study

Change in Monthly Depression score

Full Information

NCT ID

NCT04491175

First Posted

September 15, 2019

Last Updated

February 13, 2023

Sponsor

MMJ Labs LLC

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04491175

Brief Title

Impact of DuoTherm on Acute Opioid Use and Low Back Pain

Official Title

Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 23, 2022 (Actual)

Primary Completion Date

February 28, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MMJ Labs LLC

Collaborators

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

4. Oversight

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.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Evaluate opioid use and pain change in acute Low Back Pain with DuoTherm Compared to TENS Therapy Unit

Detailed Description

60 patients with acute back pain presenting for chiropractic and rehabilitation care will be stratified by gender and randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or a TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use, Low Back Pain

Keywords

pain, analgesia, medical device, opioid

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

Participants will be instructed that there are interventions being evaluated for low back pain and the impact of the medical device on medication use and pain, and that they will be self-assessing pain and use of prescribed and over the counter medications. Study staff will train them on the device or TENS units via a pre-made video, but care providers will not be informed of the study arm. An assessment for blinding will be administered at the end of the data collection for care providers and participants.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DuoTherm

Arm Type

Active Comparator

Arm Description

Arm Title

Multimodal TENS

Arm Type

Active Comparator

Arm Description

An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes.

Intervention Type

Device

Intervention Name(s)

DuoTherm

Other Intervention Name(s)

VibraCool plus heat and pressure

Intervention Description

New combination device comprising a sculpted low back plate with multiple sensory modalities held in place with a neoprene belt capable of being tightened with patient control of variations in sensory modalities.

Intervention Type

Device

Intervention Name(s)

TENS

Other Intervention Name(s)

LG Smart TENS

Intervention Description

LG SMART TENS stimulator is a portable electgrotherapy devcie featuring transcutaneous electrical nerve stimulation (TENS) therapeitud devcie, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.

Primary Outcome Measure Information:

Title

Opioid use in morphine equivalent doses

Description

Daily diary of analgesic use and dose

Time Frame

3 months

Title

Opioid initiation

Description

Use of any opioids, prescribed or borrowed

Time Frame

initial 15 days

Secondary Outcome Measure Information:

Title

Change in current weekly pain from initial to resolution

Description

Self-rated current pain on 0-11 NRS

Time Frame

3 months

Title

Change in 24 hour average pain weekly from initial to resolution

Description

Self-rated average pain over past 24 hours on 0-11 NRS

Time Frame

3 months

Title

Change in PROMIS Pain Interference measure from initial to completion of study

Description

Change in Monthly Pain Interference score

Time Frame

Initial to end of 3 months

Title

Change in PROMIS Pain Intensity measure from initial to completion of study

Description

Change in Monthly Pain Intensity score

Time Frame

Initial to end of 3 months

Title

Change in PROMIS Depression measures from initial to completion of study

Description

Change in Monthly Depression score

Time Frame

Initial to end of 3 months

Other Pre-specified Outcome Measures:

Title

Duotherm use

Description

Daily diary of use of device or sham

Time Frame

3 months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

stratified based on the representation of gender identity given and recorded in patients' chart

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, aged 18-90 diagnosed with acute low back pain by clinician; pain duration <3 months without opioid prescription for this exacerbation; self-report NRS measures >4, Capacity to understand all relevant risks and potential benefits of the study (informed consent); willingness to communicate information on prescription pill # and dose, or dose and pill type if medication is prescribed by someone else. Exclusion Criteria: Opioid prescription in the past month; 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; a contraindication to any medication for pain management that would impact analgesic use record; inability to apply DuoTherm or TENS device; pacemaker that would render patients unable to use the TENS device.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Baxter, MD

Phone

8778052899

abaxter@mmjlabs.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jena Slaski

Organizational Affiliation

Sport and Spine Clinical Research Foundation

Official's Role

Study Director

Facility Information:

Facility Name

Sport and Spine Rehab Clinics

City

Landover

State/Province

Maryland

ZIP/Postal Code

20785

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jena Slaski

Phone

301-577-1115

landoverclinic@ssrehab.com

First Name & Middle Initial & Last Name & Degree

Jena Slaski

Facility Name

Kaizo Health Fairfax

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jena Slaski

Phone

301-251-2777

fairfaxclinic@ssrehab.com

First Name & Middle Initial & Last Name & Degree

Jena Slaski

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

up to 36 months after publication of results

IPD Sharing Access Criteria

researchers providing approved methodologically sound proposals

Citations:

PubMed Identifier

19714271

Citation

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Citation

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PubMed Identifier

28017184

Citation

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Impact of DuoTherm on Acute Opioid Use and Low Back Pain

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