This is a prospective, sham-controlled, randomized, single-blinded, multi-center study comparing two different modes of the NexWave device, transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC), with an identical non-functioning NexWave sham device or self-defined standard of care for improvement of pain intensity of non-specific CLBP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
334
Device subjects receive designated treatment mode twice daily for up to 8 weeks.
Sham subjects provided with Sham Device and treatment instructions identical to that of NexWave Device Arm for their designated Sham Arm. Sham subjects participate for 4 weeks with the option to crossover to the NexWave Device Arm for an additional 4 weeks (up to 8 weeks total).
DBPS Research
Greenwood Village, Colorado, United States
McGreevy NeuroHealth
Saint Augustine, Florida, United States
Peachtree Orthopedics
Atlanta, Georgia, United States
Horizon Clinical Research
Jasper, Georgia, United States
Visual Analogue Scale Pain Rating - NexWave vs. Sham
VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects.
Time frame: Four weeks
Visual Analogue Scale Pain Rating - NexWave vs. Control
VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
Time frame: Four weeks
Oswestry Disability Index (ODI) - NexWave vs. Sham
ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.
Time frame: Four weeks
Oswestry Disability Index (OD) - NexWave vs. Control
ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
Time frame: Four weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Applied Pain Institute, LLC
Bloomington, Illinois, United States
One Oak Medical
Congers, New York, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
Summit Brain, Spine and Orthopedics
Lehi, Utah, United States