Status:
COMPLETED
Impact of DuoTherm on Opioid Use and Low Back Pain
Lead Sponsor:
MMJ Labs LLC
Collaborating Sponsors:
Sport and Spine Rehab Clinical Research Foundation
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use
Low Back Pain
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 co...
Detailed Description
160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: an M-Stim pain relief belt devi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04491175
Start Date
June 23 2022
End Date
May 29 2025
Last Update
August 19 2025
Active Locations (2)
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1
Sport and Spine Rehab Clinics
Landover, Maryland, United States, 20785
2
Kaizo Health Fairfax
Fairfax, Virginia, United States, 22030