Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain
CompletedNot applicableNCT04494841
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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)
Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.
Study details
- Official title
- Addressing Feasibility of the DuoTherm in Acute and Chronic Low Back Pain
- Conditions
- Low Back Pain
- Low Back Sprain
- Low Back Pain, Recurrent
- Interventions
- Device: Duotherm VibraCool Back Device
- Sponsor
- MMJ Labs LLC
- Collaborators
- National Institute on Drug Abuse (NIDA); Sport and Spine Rehab Clinical Research Foundation
- Start date
- 2020-01-17
- Primary completion
- 2021-01-20
- Sex
- All
- Age range
- from 18 Years to 90 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Acute or chronic low back pain as chief complaint * Capacity to understand all relevant risks and potential benefits of the study (informed consent); * Willingness to communicate information Exclusion Criteria: * 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 * Contraindication to any medication for pain management that would impact analgesic use record * Inability to apply DuoTherm
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04494841