Radiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300898
Recruitment Status : Withdrawn (Unable to enroll)
First Posted : March 10, 2006
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment
Herniated Disc Procedure: Nucleoplasty Procedure: Percutaneous decompression Procedure: Intervertebral electrothermal disc decompression (IDET) Behavioral: Conservative treatment

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : July 2006
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Nucleoplasty
Procedure/Surgery: Nucleoplasty
Procedure: Nucleoplasty
Active Comparator: Percutaneous decompression
Procedure/Surgery: Percutaneous decompression
Procedure: Percutaneous decompression
Active Comparator: Electrothermal disc decompression (IDET)
Procedure/Surgery: Intervertebral electrothermal disc decompression (IDET)
Procedure: Intervertebral electrothermal disc decompression (IDET)
Experimental: Behavioral:Conservative treatment
Conservative treatment with oral medications, physical therapy, epidural steroid injections
Behavioral: Conservative treatment

Primary Outcome Measures :
  1. VAS pain evaluation score at baseline, 1, 3, 6, 9, 12 months [ Time Frame: baseline 1, 3, 6, 9, 12 months ]

Secondary Outcome Measures :
  1. Oswestry results [ Time Frame: baseline 1, 3, 6, 9, 12 months ]
    Disability Index

  2. Quality of Life SF-36 [ Time Frame: baseline 1, 3, 6, 9, 12 months ]
    SF-36 score at baseline 1, 3, 6, 9, 12 months

  3. Return to work evaluation [ Time Frame: 1 month ]
    Return to work evaluation

  4. Depression score [ Time Frame: BASELINE ]
    Beck Depression Inventory score at pre-treatment visit

  5. Opioid use [ Time Frame: 1, 3, 6, 9, 12 months ]
    Opioid use

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300898

United States, Ohio
The Cleveland Clinic - Pain Management Department
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Leonardo Kapural, MD, OhD Cleveland Clinic Foundation, Pain Management Department

Responsible Party: The Cleveland Clinic Identifier: NCT00300898     History of Changes
Other Study ID Numbers: IRB 8006
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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