Plasma Disc Decompression Versus Conservative Care

Inclusion criteria

• Patient has one symptomatic contained, focal herniated lumbar disc.
• Patient's age should be at least 18 years old and no more than 65 years old.
• A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
• Radicular pain concordant with image findings (MRI/CT not older than 12 months).
• Disc height greater or equal to 50% of expected height in the range of a patient's normal anatomic variations and expected changes due to age.
• Patient signs informed consent.

Exclusion criteria

• Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
• Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
• Allergy to contrast media or drugs to be used in the intended procedure.
• Medical co-morbidities that preclude surgical intervention.
• Patient is receiving anti-psychotic therapy.
• Patient is a prisoner.
• Patient is incapable of understanding or responding to the study questionnaires.
• History of previous spinal surgery at, or directly adjacent to, the level to be treated.
• Patient is morbidly obese (BMI ≥ 40).
• Patient is simultaneously participating in another device or drug study related to limb/axial pain.
• Patient has a spinal fracture, tumor or infection.
• Radicular pain originating from more than one disc level.
• Axial (back) pain greater than radicular (leg) pain.
• Clinical evidence of cauda equina syndrome.
• Progressive neurologic deficit.
• Radiological evidence of spondylolisthesis at the level to be treated.
• Radiological evidence of moderate/severe stenosis at the level to be treated.
• Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.