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

Study Overview
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Brief Summary
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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.

Official Title
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Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Vertis Percutaneous Neuromodulation Therapy (PNT)
* Device: Transcutaneous Electrical Nerve Stimulation (TENS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low back pain for at least 6 months If lower extremity pain present, must be present for at least 3 months Visual analog scale (VAS) score for low back pain at least 50 out of 100 Lumbar or lumbosacral surgical intervention without pain relief Central sensitization symptoms Agrees to follow randomized treatment plan 18 years of age or older Signed informed consent form Exclusion Criteria: Significant change to low back or lower extremity pain within 4 weeks prior to enrollment Nociceptive and/or neuropathic pain symptoms in the spine due to structural and/or mechanical instabilities Three or more lumbar or lumbosacral surgical interventions; one or more surgical interventions in areas other than lumbar or lumbosacral spine Three or more lumbar vertebral segments fused Lumbar or lumbosacral surgical intervention in last 9 months; areas other than lumbar or lumbosacral in last 12 months Any additional surgical intervention required 3 months post-enrollment Symptoms consistent with sympathetically-maintained pain Evidence of serious neurological deficits or impairments Significant changes in pain medications within 4 weeks prior to enrollment Psychosocial issues that conflict with valid reporting by patient Prior treatment with percutaneous electrical stimulation or sensitivity to electrical stimulation Current use of another electrical stimulation device for low back or lower extremity pain Current enrollment in another clinical trial within the last 30 days Current or prior malignancy or cancer Serious or uncontrolled systemic illness Body mass index (BMI) greater than 40 Pregnant or intends to become pregnant during the study Implanted medical device Relationship with study staff Unable to attend study office visits or complete study measures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNT<br> | Device: Vertis Percutaneous Neuromodulation Therapy (PNT)<br>* 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<br>* Other names: Vertis;|
| Sham Comparator: TENS<br> | Device: Transcutaneous Electrical Nerve Stimulation (TENS)<br>* 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.<br>* Other names: surface stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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-averaged from the first available observation to the last available observation (12 months for completed subjects) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Lower Extremity Pain, Central Sensitization, Percutaneous Neuromodulation Therapy