Impact of DuoTherm on Acute Opioid Use and Low Back Pain

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain; Opioid Use
• Intervention / Treatment: Device: DuoTherm; Device: TENS

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Baxter, MD; Phone Number: 8778052899; Email: abaxter@mmjlabs.com

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DuoTherm; A low back pain relief device incorporating 8 harmonic patterns of mechanical stimulation (vibration) capable of neuromodulatory nociceptor block and vasodilation, 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.	Device: DuoTherm; New multi-modal 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.; Other Names: Multiple VibraCool M-Stim units plus heat and pressure
Active Comparator: Multimodal TENS; An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 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 use in morphine equivalent doses	Daily diary of analgesic use and dose	3 months
Opioid initiation	Use of any opioids, prescribed or borrowed	initial 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in current weekly pain from initial to resolution	Self-rated current pain on 0-11 NRS	3 months
Change in 24 hour average pain weekly from initial to resolution	Self-rated average pain over past 24 hours on 0-11 NRS	3 months
Change in PROMIS Pain Interference measure from initial to completion of study	Change in Monthly Pain Interference score	Initial to end of 3 months
Change in PROMIS Pain Intensity measure from initial to completion of study	Change in Monthly Pain Intensity score	Initial to end of 3 months
Change in PROMIS Depression measures from initial to completion of study	Change in Monthly Depression score	Initial to end of 3 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.
• Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
• Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.
• 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.
• Edwards RR, Haythornthwaite JA, Smith MT, Klick B, Katz JN. Catastrophizing and depressive symptoms as prospective predictors of outcomes following total knee replacement. Pain Res Manag. 2009 Jul-Aug;14(4):307-11. doi: 10.1155/2009/273783.
• Abrecht CR, Cornelius M, Wu A, Jamison RN, Janfaza D, Urman RD, Campbell C, Smith M, Haythornthwaite J, Edwards RR, Schreiber KL. Prediction of Pain and Opioid Utilization in the Perioperative Period in Patients Undergoing Primary Knee Arthroplasty: Psychophysical and Psychosocial Factors. Pain Med. 2019 Jan 1;20(1):161-171. doi: 10.1093/pm/pny020.
• 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.

Study record dates

Study Major Dates

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

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 (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: opioid; pain; medical device; analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: DuothermAcute; 4R44DA049631-02 (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: 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