Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain
CompletedNot applicableNCT04494698
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control
Study details
- Official title
- Addressing Pain and Disability From Low Back Pain With an External Multimodal Neuromodulation Device
- Conditions
- Acute Low-back Pain
- Chronic Low-back Pain
- Pain, Intractable
- Interventions
- Device: Duotherm VibraCool Back Device
- Device: TENS 8-channel unit
- Sponsor
- MMJ Labs LLC
- Collaborators
- Sport and Spine Rehab Clinical Research Foundation; National Institute on Drug Abuse (NIDA)
- Start date
- 2022-06-23
- Primary completion
- 2024-07-09
- Sex
- All
- Age range
- from 18 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria (same cohort as enrolled with NCT04491175): * 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. Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04494698