Impact of DuoTherm on Opioid Use and Low Back Pain

NCT04491175 | Completed DMC FDA Device

• 3 other identifiers: Duotherm4R44DA049631-02R44DA058952
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Opioid Use; Low Back Pain

Keywords

chronic pain; analgesia; medical device; opioid; low back pain; neuromodulation; multifidus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Opioid Use Risk Factors in the Opioid-Naive

  All opioid diaries for 3 months

• Opioid use in those with more severe pain

  All opioid diaries for 6 months

• Opioid prescribing compared to a contemporaneous national LPB prescribing of 25%

  All opioid diaries for 6 months

Study Arms (2)

Multimodal Harmonic Mechanical Stimulation Neuromodulation Wearable Belt (M-Stim)

EXPERIMENTAL

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

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

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

Interventions

M-Stim DEVICE

The casing for the device is a 54" belt with 3-button haptic controller for on-off, therapy cycles(8) and intensity(5) levels.

Also known as: DuoTherm, Multiple VibraCool M-Stim units in a harmonic array on a thermoconductive plate with optional cold, heat, and pressure

Multimodal Harmonic Mechanical Stimulation Neuromodulation Wearable Belt (M-Stim)

TENS DEVICE

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.

Also known as: LG Smart TENS

Transcutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MMJ Labs LLC: lead
• Sport and Spine Rehab Clinical Research Foundation: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Sport and Spine Rehab Clinics

Landover, Maryland, 20785, United States

Location

Kaizo Health Fairfax

Fairfax, Virginia, 22030, United States

Location

Related Publications (13)

• 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.

  PMID: 28017184 BACKGROUND

• 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.

  PMID: 25639530 BACKGROUND

• 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.

  PMID: 30445274 BACKGROUND

• 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.

  PMID: 22588748 BACKGROUND

• 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.

  PMID: 30146045 BACKGROUND

• 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.

  PMID: 16437495 BACKGROUND

• 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.

  PMID: 27033320 BACKGROUND

• 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.

  PMID: 12638100 BACKGROUND

• 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.

  PMID: 33870150 BACKGROUND

• 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.

  PMID: 27484682 BACKGROUND

• 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.

  PMID: 32947539 BACKGROUND

• 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.

  PMID: 37179530 BACKGROUND

• Baxter AL, Etnoyer-Slaski JL, Williams JAR, Swartout K, Cohen LL, Lawson ML. Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial. Front Pain Res (Lausanne). 2025 Jul 10;6:1612572. doi: 10.3389/fpain.2025.1612572. eCollection 2025.

  PMID: 40709052 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Jena Slaski

  Sport and Spine Clinical Research Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to which device powered the study hypothesis, and blinded to their assigned intervention until after documenting initial NRS pain intensity. The protocol statistician and study coordinator knew device assignments and had access to data, but did not conduct analysis. The PI and treating chiropractor were blinded to allocation and all data during enrollment, with the PI accessing data only after study completion. The analyzing statisticians were blinded to device assignment until completion of analysis. Success of participant blinding was tested with prompts, "select if you received… control or treatment" and "How confident are you?"
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Model Details: A randomized, double-blind controlled trial with 3- (aLBP) or 6- month (cLPB) follow-up.

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: July 29, 2020
• Study Start: June 23, 2022
• Primary Completion: July 9, 2024
• Study Completion: May 29, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: up to 36 months after publication of results
• Access Criteria: researchers providing approved methodologically sound proposals

Locations

US (2)