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Clinical Trial 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.


Clinical Trial 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 the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04494841
Study type Interventional
Source MMJ Labs LLC
Contact
Status Completed
Phase N/A
Start date January 17, 2020
Completion date February 18, 2021

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