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

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

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.

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