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

Phase 4

Terminated

Interventions: Device: Vertis Percutaneous Neuromodulation Therapy (PNT)
Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
PNT	Vertis Percutaneous Neuromodulation Therapy (PNT)	-
TENS	Transcutaneous Electrical Nerve Stimulation (TENS)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score	Time-averaged from the first available observation to the last available observation (12 months for completed subjects)	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.

Secondary Outcome Measures

Name	Time	Method
Total Expenditure Per Day on All Lower Back Pain Related Interventions	Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12	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.

Locations (8): UCSD Pain Research Center
🇺🇸
La Jolla, California, United States
Physical Medicine & Rehabilitation Center
🇺🇸
Seymour, Tennessee, United States
Center for Prospective Outcome Studies
🇺🇸
Atlanta, Georgia, United States
Texas Back Institute - Denton
🇺🇸
Denton, Texas, United States
Pain Specialists of Southern Oregon
🇺🇸
Medford, Oregon, United States
Mossberg Research Group
🇺🇸
Eugene, Oregon, United States
Neuropsychiatric Pain Medicine Association of Tennessee
🇺🇸
Knoxville, Tennessee, United States
Texas Back Institute CRO
🇺🇸
Plano, Texas, United States