Clinical trial NCT00189605: Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression
Official title: Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radicular Pain
Keywords: Plasma disc decompression
Intradiscal Pressure
Steroid Injection
Epidural Steroid Injection
Selective Nerve Root Injection
Leg Pain
Radicular Pain
Coblation
SNRI
Lead sponsor: ArthroCare Corporation
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity.
timeFrame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Secondary outcomes:
measure: Functional status change evaluated using the Oswestry Disability Questionnaire.
timeFrame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
measure: General health status change determined using the SF-36.
timeFrame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
measure: Employment status change examined using a questionnaire developed by the American Academy of Orthopaedic Surgeons (AAOS) and the North American Spine Society (NASS).
timeFrame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
measure: Subject global satisfaction post-procedure assessed using a global satisfaction statement.
timeFrame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
measure: Change in frequency and type of pain medication use.
timeFrame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: The Orthopedic Clinic Association
state: Arizona
city: Little Rock
country: United States
facility: Innovative Spine Care
state: Arkansas
city: Napa
country: United States
facility: SpectrumCare Rehabilitation Medical Center Inc.
state: California
city: Thornton
country: United States
facility: North Valley Rehabilitation Hospital
state: Colorado
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Arnold Pain Management Center,
state: Massachusetts
city: Ann Arbor
country: United States
facility: The University of Michigan, The Spine Program
state: Michigan
city: Edina
country: United States
facility: Medical Advanced Pain Specialists (MAPS)
state: Minnesota
city: Minneapolis
country: United States
facility: TRIA Orthropaedic Center
state: Minnesota
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: San Antonio
country: United States
facility: Consultants in Pain Research
state: Texas
city: Burlington
country: United States
facility: University of Vermont College of Medicine, Center for Pain Mgmt
state: Vermont
Study officials:
affiliation: Univ. of Pittsburgh Medical Center
name: Peter Gerzten, MD
role: PRINCIPAL_INVESTIGATOR
References: