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

Radicular Pain Clinical Trial

— SPINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189605
• Other study ID #: S-704LB
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 25, 2015
• Start date: September 2004
• Est. completion date: April 2009

Study information

• Verified date: August 2015
• Source: ArthroCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radicular Pain

Intervention

Device:
• Perc-DLR/Perc-DLG
Device technique will be used per IFU

Drug:
• Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
Injection of steroid solution into the lumbar level

Locations

Country	Name	City	State
United States	The University of Michigan, The Spine Program	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center, Arnold Pain Management Center,	Boston	Massachusetts
United States	University of Vermont College of Medicine, Center for Pain Mgmt	Burlington	Vermont
United States	OrthoCarolina	Charlotte	North Carolina
United States	Medical Advanced Pain Specialists (MAPS)	Edina	Minnesota
United States	Innovative Spine Care	Little Rock	Arkansas
United States	TRIA Orthropaedic Center	Minneapolis	Minnesota
United States	SpectrumCare Rehabilitation Medical Center Inc.	Napa	California
United States	University of Pittsburgh Medical Center (UPMC) Presbyterian	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Consultants in Pain Research	San Antonio	Texas
United States	The Orthopedic Clinic Association	Scottsdale	Arizona
United States	North Valley Rehabilitation Hospital	Thornton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
ArthroCare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity.		6 weeks, 3 mos., 6 mos., 1 year, 2 years	No
Secondary	Functional status change evaluated using the Oswestry Disability Questionnaire.		6 weeks, 3 mos., 6 mos., 1 year, 2 years	No
Secondary	General health status change determined using the SF-36.		6 weeks, 3 mos., 6 mos., 1 year, 2 years	No
Secondary	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	No
Secondary	Subject global satisfaction post-procedure assessed using a global satisfaction statement.		6 weeks, 3 mos., 6 mos., 1 year, 2 years	No
Secondary	Change in frequency and type of pain medication use.		6 weeks, 3 mos., 6 mos., 1 year, 2 years	No