Impact of DuoTherm on Opioid Use and Low Back Pain

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

Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Opioid Use
• Intervention / Treatment: Device: TENS; Device: M-Stim

Detailed Description

160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: an M-Stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be blinded to the hypothesis-driving intervention. They will be prompted daily by a Qualtrics text link to a secure data recording site collecting analgesic use and treatments, including opioid brand, dose, pill number, and source, and pain data, then weekly for 3 months (acute pain) or 6 months (chronic).

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Landover, Maryland, United States, 20785
      • Sport and Spine Rehab Clinics
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • Kaizo Health Fairfax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age18-90
• Moderate-to-severe low back pain with numeric rating scale >=4/10
• Capacity to understand informed consent
• Willingness to communicate prescriptions, pill number, dose, and source of opioids used

Exclusion Criteria:

• Opioid prescription in the past month for acute LBP (new pain <3 months)
• Radicular pain
• BMI greater than 50 (device won't fit)
• Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
• Diabetic neuropathy
• New neurologic deficits
• Skin lesions over the low back area
• Contraindication to any medication for pain management
• Inability to apply DuoTherm or TENS device
• Pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Harmonic Mechanical Stimulation Neuromodulation Wearable Belt (M-Stim); DuoTherm is a novel multimodal low back pain relief device incorporating 8 harmonic vibration patterns of mechanical stimulation (M-Stim) including neuromodulatory frequencies, 5 intensity levels, 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 at least daily for 30 minutes.	Device: M-Stim; The casing for the device is a 54" belt with 3-button haptic controller for on-off, therapy cycles(8) and intensity(5) levels.; Other Names: DuoTherm; Multiple VibraCool M-Stim units in a harmonic array on a thermoconductive plate with optional cold, heat, and pressure
Active Comparator: Transcutaneous Electrical Nerve Stimulation (TENS); A prescription 4-lead 8-channel TENS unit (LG Smart) with variable intensity settings. Patients will be instructed to use the TENS at least daily for 30 minutes.	Device: TENS; LG SMART TENS stimulator is a portable electrotherapy devcie featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, 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.; Other Names: LG Smart TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid initiation in the opioid-naive	New opioid prescriptions for subjects without history of opioids for LBP	All opioid diaries for 3 months
Opioid use in prior users	Change in milligram morphine equivalents (MME) reported daily	28 days (duration of daily recording)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use Risk Factors in the Opioid-Naive	The difference in opioid use days, MME, and those using opioids more than 7 days after presentation	All opioid diaries for 3 months
Opioid use in those with more severe pain	Opioid use days in those with the NIH Research Taskforce severity of moderate to severe in M-Stim versus TENS	All opioid diaries for 6 months
Opioid prescribing compared to a contemporaneous national LPB prescribing of 25%	New opioid prescription rate for each intervention compared to nationally prevalent prescribing rates of 25% with moderate to severe pain in outpatient settings	All opioid diaries for 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duotherm use	Daily diary of use of device or sham	3 months

Collaborators and Investigators

• Sponsor: MMJ Labs LLC
• Collaborators: National Institute on Drug Abuse (NIDA); Sport and Spine Rehab Clinical Research Foundation
• Investigators: Study Director: Jena Slaski, Sport and Spine Clinical Research Foundation

Publications and helpful links

General Publications

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
• Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.
• Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6.
• Davis CS, Lieberman AJ, Hernandez-Delgado H, Suba C. Laws limiting the prescribing or dispensing of opioids for acute pain in the United States: A national systematic legal review. Drug Alcohol Depend. 2019 Jan 1;194:166-172. doi: 10.1016/j.drugalcdep.2018.09.022. Epub 2018 Nov 3.
• Deyo RA, Hallvik SE, Hildebran C, Marino M, Dexter E, Irvine JM, O'Kane N, Van Otterloo J, Wright DA, Leichtling G, Millet LM. Association Between Initial Opioid Prescribing Patterns and Subsequent Long-Term Use Among Opioid-Naive Patients: A Statewide Retrospective Cohort Study. J Gen Intern Med. 2017 Jan;32(1):21-27. doi: 10.1007/s11606-016-3810-3. Epub 2016 Aug 2.
• Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015 Feb;95(2):e1-e18. doi: 10.2522/ptj.2015.95.2.e1.
• French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial heat or cold for low back pain. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004750. doi: 10.1002/14651858.CD004750.pub2.
• Farber K, Wieland LS. Massage for Low-back Pain. Explore (NY). 2016 May-Jun;12(3):215-7. doi: 10.1016/j.explore.2016.02.014. Epub 2016 Mar 2.
• Nadler SF, Steiner DJ, Petty SR, Erasala GN, Hengehold DA, Weingand KW. Overnight use of continuous low-level heatwrap therapy for relief of low back pain. Arch Phys Med Rehabil. 2003 Mar;84(3):335-42. doi: 10.1053/apmr.2003.50103.
• Delitto A, Patterson CG, Stevans JM, Freburger JK, Khoja SS, Schneider MJ, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Beneciuk JM, George SZ, Saper RB. Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial. EClinicalMedicine. 2021 Mar 30;34:100795. doi: 10.1016/j.eclinm.2021.100795. eCollection 2021 Apr.
• Hayden JA, Ellis J, Asbridge M, Ogilvie R, Merdad R, Grant DAG, Stewart SA, Campbell S. Prolonged opioid use among opioid-naive individuals after prescription for nonspecific low back pain in the emergency department. Pain. 2021 Mar 1;162(3):740-748. doi: 10.1097/j.pain.0000000000002075.
• Baxter AL, Thrasher A, Etnoyer-Slaski JL, Cohen LL. Multimodal mechanical stimulation reduces acute and chronic low back pain: Pilot data from a HEAL phase 1 study. Front Pain Res (Lausanne). 2023 Apr 26;4:1114633. doi: 10.3389/fpain.2023.1114633. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): July 9, 2024
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: chronic pain; opioid; low back pain; medical device; neuromodulation; analgesia; multifidus
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Duotherm; 4R44DA049631-02 (U.S. NIH Grant/Contract); R44DA058952 (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 access, 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; 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.: No