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Clinical Trial Summary

This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.


Clinical Trial Description

Research Objectives: This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain. The investigators hypothesize that those assigned to using the device will report reduced back pain compared with those in the control condition; with those using the device also showing improvement in sleep, mood, and level of activity. The investigators hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain. The investigators hypothesize that the device will be safe to use and will demonstrate a reduction in healthcare utilization (reduced clinic and Emergency Department visits). Finally, based on preliminary analyses limited by few subject numbers, the investigators will investigate whether certain individuals report greater benefit from using the Quell than others and, in particular, would predict that those with more intense and longer duration of pain will demonstrate most benefit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02944513
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Completed
Phase N/A
Start date October 2016
Completion date August 2018

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