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

RS Medical

Status and phase

Terminated

Phase 4

Conditions

Low Back Pain

Treatments

Device: Vertis Percutaneous Neuromodulation Therapy (PNT)

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00290238

RSMED-K011702-PNT02

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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