Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation
Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation
The purpose of this study is to learn which of three minimally invasive procedures is the
 most effective for treatment of contained lumbar disc herniation.
Contained herniation of the lumbar intervertebral disc is a frequent cause of leg and back
 pain. Over the last decade, there is a tendency to shift from surgical treatment of the
 intervertebral disc including laminectomy/discectomy to an excess of nonoperative management.
 Three techniques introduced recently are used as minimally invasive treatments for
 decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation®
 radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter
 disc decompression uses heat from a resistive coil positioned in the area of disc herniation
 while Dekompressor® uses volume reduction to decrease an intradiscal pressure.

 This is a comparison study which investigates if intervertebral electrothermal disc
 decompression produces better pain relief measured on VAS scale, improvement in functional
 capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression
 (Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled
 study. Patients will be randomized into four treatment groups in equal numbers. The first
 group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc
 decompression, the third will receive thermal treatment using decompression catheter
 (Achutherm TM) and the forth will be the control group. The control group will be treated
 conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg
 1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy.

 Patients will be followed and assessed at one, three, six, nine and twelve months following
 the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and
 return to work evaluation.
Inclusion Criteria:

 -  History of concordant radicular leg pain unresponsive to conservative treatment for
 longer than 3 months

 -  Leg pain must be greater than back pain

 -  Contained disc herniation as evidenced by MRI

 -  No evidence of psychological issues by exam or history

 Exclusion Criteria:

 -  A score of greater than 10 on Beck Depression Inventory (BDI)

 -  Patients with pending workers compensation claim or litigation

 -  Pregnancy

 -  Tumor

 -  Systemic infection or localized infection at the anticipated entry needle site

 -  Traumatic spinal fracture

 -  History of coagulopathy

 -  Unexplained bleeding

 -  Progressive neurological deficits

 -  History of opioid abuse or patients currently on long acting opioids

 -  Patients presenting with moderate or severe lumbar central or lateral canal stenosis,
 free disc fragments or degenerative disc disease as described on MRI