Radiofrequency Nucleoplasty Vs Percutaneous Nucleotomy (Dekompressor) Vs Decompression Catheter for the Treatment of Painful 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