Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients

PHASE4TerminatedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

November 30, 2007

Study Completion Date

September 30, 2008

Conditions
Low Back Pain
Interventions
DEVICE

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"

DEVICE

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."

Trial Locations (8)

37865

Physical Medicine & Rehabilitation Center, Seymour

37922

Neuropsychiatric Pain Medicine Association of Tennessee, Knoxville

75093

Texas Back Institute CRO, Plano

76208

Texas Back Institute - Denton, Denton

92037

UCSD Pain Research Center, La Jolla

97401

Mossberg Research Group, Eugene

97504

Pain Specialists of Southern Oregon, Medford

03027

Center for Prospective Outcome Studies, Atlanta

Sponsors

Lead Sponsor

All Listed Sponsors
lead

RS Medical

INDUSTRY

NCT00290238 - Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients | Biotech Hunter | Biotech Hunter