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CompletedNCT00189605SPINEUpdated Aug 26, 2015

Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression

A Phase 4 interventional study of Perc-DLR/Perc-DLG and Fluoroscopy guided transforaminal epidural steroid injection (TFESI) in Radicular Pain, sponsored by ArthroCare Corporation. Completed at 13 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-08-26.

Sponsored by ArthroCare Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this post-marketing surveillance study is to compare two procedures which are used to treat patients who require a disc decompression procedure. These procedures are: 1) plasma disc decompression procedure using Coblation technology and 2) fluoroscopy guided transforaminal epidural steroid injection (TFESI). The study will evaluate treatment efficacy and rate of improvement in symptoms through the first six months following the procedure.

The principal objectives of this study are to determine whether subjects receiving the plasma disc decompression procedure demonstrate:

  1. Improved clinical outcomes over subjects receiving TFESI
  2. More rapid reversal of symptoms than subjects receiving TFESI
Read the detailed description

Chronic leg and back pain are two of the most common ailments in our society, and are associated with serious financial and social consequences. One surgical treatment modality is plasma disc decompression, based on the principle that inducing a small reduction of volume in the closed hydraulic space of an intact (contained herniated) disc can relieve pressure, and thereby reduce or eliminate pain. Another widely accepted treatment is transforaminal epidural steroid injection (TFESI), which delivers a high concentration of corticosteroid to the targeted disc nerve interface, and is thought to decrease pain by reducing inflammation.

This study proposes to compare the efficacy of the plasma disc decompression procedure to the standard TFESI series in patients who have failed to improve after an initial TFESI injection. The goal is to better understand the differences between these two treatment modalities and to monitor the rates of symptom improvement through the first six months between patients receiving a series of at least two selective nerve root injections and those undergoing the one-time plasma disc decompression procedure after failing one fluoroscopy guided TFESI. Patients will continue to be monitored over the 2-year post-procedure period to assess stability of treatment effect.

02

Conditions studied

  • Radicular Pain

Keywords

  • Plasma disc decompression
  • Intradiscal Pressure
  • Steroid Injection
  • Epidural Steroid Injection
  • Selective Nerve Root Injection
  • Leg Pain
  • Radicular Pain
  • Coblation
  • SNRI
03

In context

Lead sponsor

ArthroCare Corporation is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient has one symptomatic contained, focal herniated lumbar disc.
  2. Patient's age should be at least 18 years old and no more than 75 years old.
  3. Selective nerve root injection or epidural steroid injection for symptomatic herniated disc, received between 3 weeks and six months ago.
  4. A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
  5. Radicular pain concordant with image findings (MRI or CT).
  6. Disc height greater than 50%.
  7. Patient signs informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
  2. Patient is receiving Worker's compensation or is in litigation related to back/leg pain.
  3. Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
  4. Allergy to contrast media or drugs to be used in the intended procedure.
  5. Medical co-morbidities that preclude surgical intervention.
  6. Patient is receiving anti-psychotic therapy.
  7. Patient is a prisoner.
  8. Patient is incapable of understanding or responding to the study questionnaires.
  9. History of previous spinal surgery at, or directly adjacent to, the level to be treated.
  10. Patient is morbidly obese (BMI ≥ 40).
  11. Patient is simultaneously participating in another device or drug study related to limb/axial pain.
  12. Patient has a spinal fracture, tumor or infection.
  13. Radicular pain originating from more than one disc level.
  14. Axial (back) pain greater than radicular (leg) pain.
  15. Clinical evidence of cauda equina syndrome.
  16. Progressive neurologic deficit.
  17. Radiological evidence of spondylolisthesis at the level to be treated.
  18. Radiological evidence of moderate/severe stenosis at the level to be treated.
  19. Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    1

    Fluoroscopy guided transforaminal epidural steroid injection (TFESI)

    Drug: Fluoroscopy guided transforaminal epidural steroid injection (TFESI)

  • Experimental
    2

    Percutaneous Disc Decompression of the lumbar level which is secondary to radicular pain

    Device: Perc-DLR/Perc-DLG

Interventions

  • DevicePerc-DLR/Perc-DLG

    Device technique will be used per IFU

    Also known as: Percutaneous Disc Decompression

  • DrugFluoroscopy guided transforaminal epidural steroid injection (TFESI)

    Injection of steroid solution into the lumbar level

    Also known as: TFESI

06

What researchers measure

Primary outcomes

  1. Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity.

    Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years

Secondary outcomes

  1. Functional status change evaluated using the Oswestry Disability Questionnaire.

    Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years

  2. General health status change determined using the SF-36.

    Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years

  3. Employment status change examined using a questionnaire developed by the American Academy of Orthopaedic Surgeons (AAOS) and the North American Spine Society (NASS).

    Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years

  4. Subject global satisfaction post-procedure assessed using a global satisfaction statement.

    Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years

  5. Change in frequency and type of pain medication use.

    Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years

07

Study locations

13 sites
  • The Orthopedic Clinic Association
    Scottsdale, Arizona 85260, United States
  • Innovative Spine Care
    Little Rock, Arkansas 72205, United States
  • SpectrumCare Rehabilitation Medical Center Inc.
    Napa, California 94558, United States
  • North Valley Rehabilitation Hospital
    Thornton, Colorado 80229, United States
  • Beth Israel Deaconess Medical Center, Arnold Pain Management Center,
    Boston, Massachusetts 02215, United States
  • The University of Michigan, The Spine Program
    Ann Arbor, Michigan 48108, United States
  • Medical Advanced Pain Specialists (MAPS)
    Edina, Minnesota 55435, United States
  • TRIA Orthropaedic Center
    Minneapolis, Minnesota 55431, United States
  • OrthoCarolina
    Charlotte, North Carolina 28203, United States
  • University of Pittsburgh Medical Center (UPMC) Presbyterian
    Pittsburgh, Pennsylvania 15213-2582, United States
  • Western Pennsylvania Hospital
    Pittsburgh, Pennsylvania 15224, United States
  • Consultants in Pain Research
    San Antonio, Texas 78209, United States
  • University of Vermont College of Medicine, Center for Pain Mgmt
    Burlington, Vermont 05401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00189605
Lead sponsor
ArthroCare Corporation
Responsible party
Sponsor
First posted
Sep 19, 2005
Start date
Sep 2004
Primary completion
Dec 2007
Completion
Apr 2009
Last update
Aug 26, 2015

Study contacts

Peter Gerzten, MD
principal investigator · Univ. of Pittsburgh Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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