Clinical trial NCT00300898: Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation
Official title: Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy (Dekompressor) vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Herniated Disc
Keywords: contained lumbar herniated disc
nucleoplasty
percutaneous decompression
Dekompressor
intervertebral electrothermal disc decompression
IDET
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2006-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months
timeFrame: baseline 1, 3, 6, 9, 12 months
Secondary outcomes:
measure: Oswestry results
timeFrame: baseline 1, 3, 6, 9, 12 months
measure: Quality of Life SF-36
timeFrame: baseline 1, 3, 6, 9, 12 months
measure: Return to work evaluation
timeFrame: 1 month
measure: Depression score
timeFrame: BASELINE
measure: Opioid use
timeFrame: 1, 3, 6, 9, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland Clinic Foundation, Pain Management Department
name: Leonardo Kapural, MD, OhD
role: PRINCIPAL_INVESTIGATOR
References: