Radiofrequency Nucleoplasty Vs Percutaneous Nucleotomy (Dekompressor) Vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation
Recruitment status was Not yet recruiting
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.
Procedure: Percutaneous decompression
Procedure: Intervertebral electrothermal disc decompression (IDET)
Behavioral: Conservative treatment with oral medications, physical therapy, epidural steroid injections.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months
- Oswestry results at baseline, 1, 3, 6, 9 12 months
- SF-36 core at baseline, 1, 3, 6, 9 12 months
- Return to work evaluation
- Beck Depression Inventory score at pre-treatment visit
- Opioid use
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||July 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300898
|Contact: Leonardo Kapural, MD, PhDfirstname.lastname@example.org|
|Contact: Nagy Mekhail, MD, PhDemail@example.com|
|United States, Ohio|
|The Cleveland Clinic - Pain Management Department||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Leonardo Kapural, MD, PhD 216-444-6325 firstname.lastname@example.org|
|Contact: Nagy Mekhail, MD, PhD 216-444-9114 email@example.com|
|Principal Investigator: Leonardo Kapural, MD, PhD|
|Sub-Investigator: Nagy Mekhail, MD, PhD|
|Sub-Investigator: Salim Hayek, MD, PhD|
|Sub-Investigator: Anantha Reddy, MD|
|Sub-Investigator: Russell DeMicco, DO|
|Sub-Investigator: Teresa Dews, MD|
|Principal Investigator:||Leonardo Kapural, MD, OhD||Cleveland Clinic Foundation, Pain Management Department|