NCT00189605

Brief 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. 1.Improved clinical outcomes over subjects receiving TFESI
  2. 2.More rapid reversal of symptoms than subjects receiving TFESI

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_4

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

August 25, 2015

Conditions

Radicular Pain

Keywords

Plasma disc decompressionIntradiscal PressureSteroid InjectionEpidural Steroid InjectionSelective Nerve Root InjectionLeg PainRadicular PainCoblationSNRI

Outcome Measures

Primary Outcomes (1)

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

    6 weeks, 3 mos., 6 mos., 1 year, 2 years

Secondary Outcomes (5)

  • Functional status change evaluated using the Oswestry Disability Questionnaire.

    6 weeks, 3 mos., 6 mos., 1 year, 2 years

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

    6 weeks, 3 mos., 6 mos., 1 year, 2 years

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

    6 weeks, 3 mos., 6 mos., 1 year, 2 years

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

    6 weeks, 3 mos., 6 mos., 1 year, 2 years

  • Change in frequency and type of pain medication use.

    6 weeks, 3 mos., 6 mos., 1 year, 2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Fluoroscopy guided transforaminal epidural steroid injection (TFESI)

Drug: Fluoroscopy guided transforaminal epidural steroid injection (TFESI)

2

EXPERIMENTAL

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

Device: Perc-DLR/Perc-DLG

Interventions

Perc-DLR/Perc-DLGDEVICE

Device technique will be used per IFU

Also known as: Percutaneous Disc Decompression
2
Fluoroscopy guided transforaminal epidural steroid injection (TFESI)DRUG

Injection of steroid solution into the lumbar level

Also known as: TFESI
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
  • Patient is receiving Worker's compensation or is in litigation related to back/leg pain.
  • Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
  • Allergy to contrast media or drugs to be used in the intended procedure.
  • Medical co-morbidities that preclude surgical intervention.
  • Patient is receiving anti-psychotic therapy.
  • Patient is a prisoner.
  • Patient is incapable of understanding or responding to the study questionnaires.
  • History of previous spinal surgery at, or directly adjacent to, the level to be treated.
  • Patient is morbidly obese (BMI ≥ 40).
  • Patient is simultaneously participating in another device or drug study related to limb/axial pain.
  • Patient has a spinal fracture, tumor or infection.
  • Radicular pain originating from more than one disc level.
  • Axial (back) pain greater than radicular (leg) pain.
  • Clinical evidence of cauda equina syndrome.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

The Orthopedic Clinic Association

Scottsdale, Arizona, 85260, United States

Location

Innovative Spine Care

Little Rock, Arkansas, 72205, United States

Location

SpectrumCare Rehabilitation Medical Center Inc.

Napa, California, 94558, United States

Location

North Valley Rehabilitation Hospital

Thornton, Colorado, 80229, United States

Location

Beth Israel Deaconess Medical Center, Arnold Pain Management Center,

Boston, Massachusetts, 02215, United States

Location

The University of Michigan, The Spine Program

Ann Arbor, Michigan, 48108, United States

Location

Medical Advanced Pain Specialists (MAPS)

Edina, Minnesota, 55435, United States

Location

TRIA Orthropaedic Center

Minneapolis, Minnesota, 55431, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28203, United States

Location

University of Pittsburgh Medical Center (UPMC) Presbyterian

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Consultants in Pain Research

San Antonio, Texas, 78209, United States

Location

University of Vermont College of Medicine, Center for Pain Mgmt

Burlington, Vermont, 05401, United States

Location

Study Officials

  • Peter Gerzten, MD

    Univ. of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

September 1, 2004

Primary Completion

December 1, 2007

Study Completion

April 1, 2009

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

US(13)