122
Participants
Start Date
December 31, 2005
Primary Completion Date
November 30, 2007
Study Completion Date
September 30, 2008
Vertis Percutaneous Neuromodulation Therapy (PNT)
"* Ten PNT sessions in eleven weeks~* On average, one PNT session per week~* Ten lumbar Safeguide electrodes (three centimeters in length) deployed per lumbar montage~* Forty-five minutes of electrical stimulation for each session~* Electrical stimulation parameters:~ * Continuous 50 Hz current~ * Charge-balanced, biphasic (each phase is 200 microsec), rectangular waveform~ * Intensity to subject's tolerance for ten minutes then increased to a mildly uncomfortable level"
Transcutaneous Electrical Nerve Stimulation (TENS)
"* Ten TENS sessions in eleven weeks~* On average, one TENS session per week~* Four 2-inch (5.1 centimeters) diameter pads applied per TENS lumbar montage~* Forty-five minutes of electrical stimulation for each session~* Electrical stimulation parameters:~ * Current at 2 Hz-low frequency~ * Pulse trains delivered as asymmetric, biphasic, square waveform current, with pulse width lasting 20 microsec~ * Intensity titrated according to subject's sensory threshold~ * To maintain blinding, the treating physician or clinician will check on the subject after 10 minutes and dial the channels down just prior to the point of turning off the device."
Physical Medicine & Rehabilitation Center, Seymour
Neuropsychiatric Pain Medicine Association of Tennessee, Knoxville
Texas Back Institute CRO, Plano
Texas Back Institute - Denton, Denton
UCSD Pain Research Center, La Jolla
Mossberg Research Group, Eugene
Pain Specialists of Southern Oregon, Medford
Center for Prospective Outcome Studies, Atlanta
Lead Sponsor
RS Medical
INDUSTRY