Status:
COMPLETED
Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain
Lead Sponsor:
MMJ Labs LLC
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Sport and Spine Rehab Clinical Research Foundation
Conditions:
Low Back Pain
Low Back Sprain
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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.
Detailed Description
To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04494841
Start Date
January 17 2020
End Date
February 18 2021
Last Update
October 21 2022
Active Locations (1)
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1
Sport and Spine Rehab Clinic
Rockville, Maryland, United States, 20852