Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain
NCT ID: NCT04494698
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2022-06-23
2025-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DuoTherm VibraCool Back Device
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.
Duotherm VibraCool Back Device
Active New multimodal pain device
Multimodal TENS Unit
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.
TENS 8-channel unit
LG Smart TENS unit
Interventions
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Duotherm VibraCool Back Device
Active New multimodal pain device
TENS 8-channel unit
LG Smart TENS unit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Sport and Spine Rehab Clinical Research Foundation
OTHER
National Institute on Drug Abuse (NIDA)
NIH
MMJ Labs LLC
INDUSTRY
Responsible Party
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Amy Lynn Baxter
Principal Investigator
Principal Investigators
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Amy Baxter, MD
Role: PRINCIPAL_INVESTIGATOR
Pain Care Labs (a dba of MMJ Labs)
Locations
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Sport and Spine Rehab Clinics
Landover, Maryland, United States
Sport and Spine Rehab Clinic
Fairfax, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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DuoTherm for Low Back Pain
Identifier Type: -
Identifier Source: org_study_id
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