Radiofrequency Nucleoplasty Vs Percutaneous Nucleotomy (Dekompressor) Vs Decompression Catheter for the Treatment of Painful Contained Lumbar Disc Herniation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by The Cleveland Clinic.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00300898
First received: March 8, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Herniated Disc
Procedure: Nucleoplasty
Procedure: Percutaneous decompression
Procedure: Intervertebral electrothermal disc decompression (IDET)
Behavioral: Conservative treatment with oral medications, physical therapy, epidural steroid injections.

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 72
Study Start Date: July 2006
Estimated Study Completion Date: July 2008
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

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300898

Contacts
Contact: Leonardo Kapural, MD, PhD 216-444-6325 kapural@ccf.org
Contact: Nagy Mekhail, MD, PhD 216-444-9114 mekhain@ccf.org

Locations
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    kapural@ccf.org   
Contact: Nagy Mekhail, MD, PhD    216-444-9114    mekhain@ccf.org   
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         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Leonardo Kapural, MD, OhD Cleveland Clinic Foundation, Pain Management Department
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00300898     History of Changes
Other Study ID Numbers: IRB 8006
Study First Received: March 8, 2006
Last Updated: March 8, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
contained lumbar herniated disc
nucleoplasty
percutaneous decompression
Dekompressor
intervertebral electrothermal disc decompression
IDET

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014