Status:
COMPLETED
Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain
Lead Sponsor:
MMJ Labs LLC
Collaborating Sponsors:
Sport and Spine Rehab Clinical Research Foundation
National Institute on Drug Abuse (NIDA)
Conditions:
Acute Low-back Pain
Chronic Low-back Pain
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control
Detailed Description
160 patients with moderate to severe acute or exacerbations of chronic low back pain presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: a pain relief belt...
Eligibility Criteria
Inclusion
- Inclusion Criteria (same cohort as enrolled with NCT04491175):
- Presentation for treatment of acute or acute exacerbation of chronic low back pain
- Self-report NRS measures \>=4 (moderate to severe)
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Willingness to communicate information on prescription pill # and dose, or dose and pill type if medication is prescribed by someone else.
- Exclusion Criteria:
- Pacemaker
- Radicular pain likely reflecting a surgical or mechanical problem
- BMI greater than 50 (device won't fit, initially thought to be BMI 30 but up to 50 included)
- 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 or Active Control TENS Device
Exclusion
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04494698
Start Date
June 23 2022
End Date
June 24 2025
Last Update
July 18 2025
Active Locations (2)
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1
Sport and Spine Rehab Clinics
Landover, Maryland, United States, 20785
2
Sport and Spine Rehab Clinic
Fairfax, Virginia, United States, 22030