MedTrace Logo

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

NCT00290238 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2009-06-01

Study results available
· View outcomes & findings →

Summary

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.

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.

Sponsors & Collaborators

  • RS Medical

    lead INDUSTRY

Principal Investigators

  • William Carroll · RS Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-11-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290238 on ClinicalTrials.gov