Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Vertis Percutaneous Neuromodulation Therapy (PNT); Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention description: 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; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Low Back Pain; Lower Extremity Pain; Central Sensitization; Percutaneous Neuromodulation Therapy

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.
    

Eligibility criteria:

        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