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

This study has been completed.
Sponsor:
Information provided by:
ArthroCare Corporation
ClinicalTrials.gov Identifier:
NCT00189605
First received: September 13, 2005
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

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

Condition Intervention Phase
Radicular Pain
 Device: Perc-DLR/Perc-DLG
Drug: Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression Efficacy

Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional status change evaluated using the Oswestry Disability Questionnaire. [ Time Frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years ] [ Designated as safety issue: No ]
  • General health status change determined using the SF-36. [ Time Frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject global satisfaction post-procedure assessed using a global satisfaction statement. [ Time Frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years ] [ Designated as safety issue: No ]
  • Change in frequency and type of pain medication use. [ Time Frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: September 2004
Study Completion Date: April 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
 Drug: Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
Injection of steroid solution into the lumbar level
Other Name: TFESI
Experimental: 2
Percutaneous Disc Decompression of the lumbar level which is secondary to radicular pain
 Device: Perc-DLR/Perc-DLG
Device technique will be used per IFU
Other Name: Percutaneous Disc Decompression

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189605

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

No publications provided

Responsible Party: Wendy Winters, ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT00189605     History of Changes
Other Study ID Numbers: S-704LB
Study First Received: September 13, 2005
Last Updated: July 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ArthroCare Corporation:
Plasma disc decompression
Intradiscal Pressure
Steroid Injection
Epidural Steroid Injection
Selective Nerve Root Injection
 Leg Pain
Radicular Pain
Coblation
SNRI

ClinicalTrials.gov processed this record on May 16, 2013