Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain

NCT04494698 | Completed DMC FDA Device

• 2 other identifiers: DuoTherm for Low Back Pain4R44DA049631
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control

Conditions

Acute Low-back Pain; Chronic Low-back Pain; Pain, Intractable

Keywords

chronic low back pain; spine pain; medical device; analgesia; vibration; Multifidus

Outcome Measures

Primary Outcomes (2)

• Change in current pain intensity from initial to final

  Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain

  Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

  Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe

  Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)

Secondary Outcomes (2)

• Resolution of disability using PROMIS Pain Interference

  Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies

  Initial through 6 month measurements (or 13 week if chronic enrolled as acute)

Study Arms (2)

DuoTherm VibraCool Back Device

EXPERIMENTAL

A multimodal low back pain relief device incorporating 8 mechanical stimulation patterns of vibration and 5 intensity settings with optional heat, cold, or pressure delivered through a sculpted metal plate attached by a belt and controlled by buttons on the belt. Patients will be instructed to use the device daily for 30 minutes.

Device: Duotherm VibraCool Back Device

Multimodal TENS Unit

ACTIVE COMPARATOR

LG SMART TENS stimulator is an 8-channel portable electrotherapy device 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.

Device: TENS 8-channel unit

Interventions

Duotherm VibraCool Back Device DEVICE

Active New multimodal pain device

Also known as: Vibracool plus heat or pressure, Buzzy

DuoTherm VibraCool Back Device

TENS 8-channel unit DEVICE

LG Smart TENS unit

Multimodal TENS Unit

Eligibility Criteria

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

You may qualify if:

• Presentation for treatment of acute or acute exacerbation of chronic low back pain
• Self-report NRS measures \>=4 (moderate to severe)
• 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.

You may not qualify if:

• Pacemaker
• Radicular pain likely reflecting a surgical or mechanical problem
• BMI greater than 50 (device won't fit, initially thought to be BMI 30 but up to 50 included)
• 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 or Active Control TENS Device

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

Sport and Spine Rehab Clinic

Fairfax, Virginia, 22030, United States

Location

Related Publications (11)

• 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

• 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.

  PMID: 11690728 BACKGROUND

• 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

• 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

• 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.

  PMID: 26329399 BACKGROUND

• Maddalozzo GF, Kuo B, Maddalozzo WA, Maddalozzo CD, Galver JW. Comparison of 2 Multimodal Interventions With and Without Whole Body Vibration Therapy Plus Traction on Pain and Disability in Patients With Nonspecific Chronic Low Back Pain. J Chiropr Med. 2016 Dec;15(4):243-251. doi: 10.1016/j.jcm.2016.07.001. Epub 2016 Aug 25.

  PMID: 27857632 BACKGROUND

• Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.

  PMID: 32245841 BACKGROUND

• Tang X, Schalet BD, Hung M, Brodke DS, Saltzman CL, Cella D. Linking Oswestry Disability Index to the PROMIS pain interference CAT with equipercentile methods. Spine J. 2021 Jul;21(7):1185-1192. doi: 10.1016/j.spinee.2021.02.012. Epub 2021 Feb 19.

  PMID: 33610807 BACKGROUND

• Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Sayed D, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Maislin G, Heemels JP, Eldabe S. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024 Jul;27(5):930-943. doi: 10.1016/j.neurom.2024.01.006. Epub 2024 Mar 12.

  PMID: 38483366 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, Tucker O, Williams JAR, Swartout K, Cohen LL, Lawson ML. Novel multimodal mechanical stimulation is superior to TENS to treat and prevent chronic low back pain: a randomized controlled trial. Front Pain Res (Lausanne). 2025 Aug 18;6:1625420. doi: 10.3389/fpain.2025.1625420. eCollection 2025.

  PMID: 40901560 DERIVED

MeSH Terms

Conditions

Pain, Intractable; Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Baxter, MD

  Pain Care Labs (a dba of MMJ Labs)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be instructed that non-drug interventions are being evaluated for their impact on opioid use and pain with low back pain, and that they will be self-assessing pain and reporting 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 investigators and outcomes assessors (statistician) will not be informed of the hypothesis-driving condition arm. An assessment for blinding will be administered at the end of the data collection for participants, asking whether participants believe they are in treatment or control, and how confident they are.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized active control

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: June 23, 2022
• Primary Completion: July 9, 2024
• Study Completion: June 24, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

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

Locations

US (2)