The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
* 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
* 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.
UCSD Pain Research Center
La Jolla, California, United States
Center for Prospective Outcome Studies
Atlanta, Georgia, United States
Mossberg Research Group
Eugene, Oregon, United States
Pain Specialists of Southern Oregon
Medford, Oregon, United States
Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
Visual analog scale (VAS) for pain (100mm line with "0/No pain" on the left and "100/Worst pain imaginable" on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits.
Time frame: Time-averaged from the first available observation to the last available observation (12 months for completed subjects)
Total Expenditure Per Day on All Lower Back Pain Related Interventions
Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers' Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.
Time frame: Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12
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Neuropsychiatric Pain Medicine Association of Tennessee
Knoxville, Tennessee, United States
Physical Medicine & Rehabilitation Center
Seymour, Tennessee, United States
Texas Back Institute - Denton
Denton, Texas, United States
Texas Back Institute CRO
Plano, Texas, United States