Impact of DuoTherm on Opioid Use and Low Back Pain
CompletedNot applicableNCT04491175
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 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)
Study details
- Official title
- Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing Pain Relief in Acute and Chronic Low Back Pain
- Conditions
- Interventions
- Device: M-Stim
- Device: TENS
- 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: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04491175