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 range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.