CompletedNot Applicable

Impact of DuoTherm on Opioid Use and Low Back Pain

United States160 participantsStarted 2022-06-23

Plain-language summary

Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)

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: * Age18-90 * Moderate-to-severe low back pain with numeric rating scale \>=4/10 * Capacity to understand informed consent * Willingness to communicate prescriptions, pill number, dose, and source of opioids used Exclusion Criteria: * Opioid prescription in the past month for acute LBP (new pain \<3 months) * Radicular pain * BMI greater than 50 (device won't fit) * Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease) * Diabetic neuropathy * New neurologic deficits * Skin lesions over the low back area * Contraindication to any medication for pain management * Inability to apply DuoTherm or TENS device * Pacemaker

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

Opioid initiation in the opioid-naive

Timeframe: All opioid diaries for 3 months

Opioid use in prior users

Timeframe: 28 days (duration of daily recording)

Trial details

NCT IDNCT04491175

SponsorMMJ Labs LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-09

View on ClinicalTrials.gov More Opioid Use 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.