CompletedNot Applicable

Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

United States20 participantsStarted 2020-01-17

Plain-language summary

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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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

What they're measuring

Change in Pain: Visual Analog Scale (VAS)

Timeframe: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation

Participants' Choice in Thermal Options

Timeframe: 30 minutes

Would You Recommend

Timeframe: After 30 minutes

Trial details

NCT IDNCT04494841

SponsorMMJ Labs LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-01-20

Results submitted2022-08-10

View on ClinicalTrials.gov More Low Back Pain trials