Radicular PainPhase 4SPINENCT00189605
Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression
A Phase 4 study testing Perc-DLR/Perc-DLG and Fluoroscopy guided transforaminal epidural steroid injection (TFESI) in people with Radicular Pain, run by ArthroCare Corporation at 13 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radicular Pain
- What is being tested?
- Perc-DLR/Perc-DLG and Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2004to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Progressive neurologic deficit.
- Radiological evidence of spondylolisthesis at the level to be treated.
- Radiological evidence of moderate/severe stenosis at the level to be treated.
- Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
The University of Michigan, The Spine Program
Ann Arbor, Michigan, 48108
Beth Israel Deaconess Medical Center, Arnold Pain Management Center,
Boston, Massachusetts, 02215
University of Vermont College of Medicine, Center for Pain Mgmt
Burlington, Vermont, 05401
OrthoCarolina
Charlotte, North Carolina, 28203
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, 55435
Innovative Spine Care
Little Rock, Arkansas, 72205
TRIA Orthropaedic Center
Minneapolis, Minnesota, 55431
SpectrumCare Rehabilitation Medical Center Inc.
Napa, California, 94558
University of Pittsburgh Medical Center (UPMC) Presbyterian
Pittsburgh, Pennsylvania, 15213-2582
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Consultants in Pain Research
San Antonio, Texas, 78209
The Orthopedic Clinic Association
Scottsdale, Arizona, 85260
North Valley Rehabilitation Hospital
Thornton, Colorado, 80229
About this study
Official title: Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression Efficacy
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:
- Improved clinical outcomes over subjects receiving TFESI
- 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.
- Conditions
- Radicular Pain
- Being tested
- Perc-DLR/Perc-DLG, Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
- Keywords
- Plasma disc decompression, Intradiscal Pressure, Steroid Injection, Epidural Steroid Injection, Selective Nerve Root Injection, Leg Pain, Radicular Pain, Coblation, SNRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perc-DLR/Perc-DLGDevice
Also called Percutaneous Disc Decompression
Device technique will be used per IFU
Fluoroscopy guided transforaminal epidural steroid injection (TFESI)Drug
Also called TFESI
Injection of steroid solution into the lumbar level
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fluoroscopy guided transforaminal epidural steroid injection (TFESI) Receives: Drug: Fluoroscopy guided transforaminal epidural steroid injection (TFESI) |
| 2 | Experimental | Percutaneous Disc Decompression of the lumbar level which is secondary to radicular pain Receives: Device: Perc-DLR/Perc-DLG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity.
Measured: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Secondary outcomes (5)
Functional status change evaluated using the Oswestry Disability Questionnaire.
Measured: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
General health status change determined using the SF-36.
Measured: 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).
Measured: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Subject global satisfaction post-procedure assessed using a global satisfaction statement.
Measured: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Change in frequency and type of pain medication use.
Measured: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radicular PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroCare Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Gerzten, MD, Principal investigator, Univ. of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189605
- Sponsor's protocol ID
- S-704LB
- Acronym
- SPINE
- Status last verified
- Aug 2015
- First submitted
- 13 Sep 2005
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression Efficacy
- ClinicalTrials.gov ID
- NCT00189605
- Acronym / sponsor ID
- SPINE / S-704LB
- Conditions
- Radicular Pain
- Keywords
- Plasma disc decompression, Intradiscal Pressure, Steroid Injection, Epidural Steroid Injection, Selective Nerve Root Injection, Leg Pain, Radicular Pain, Coblation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- ArthroCare CorporationUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Improved clinical outcomes over subjects receiving TFESI
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Fluoroscopy guided transforaminal epidural steroid injection (TFESI)Fluoroscopy guided transforaminal epidural steroid injection (TFESI) |
| 2 | Experimental | Device: Perc-DLR/Perc-DLGPercutaneous Disc Decompression of the lumbar level which is secondary to radicular pain |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perc-DLR/Perc-DLGAlso: Percutaneous Disc DecompressionDevice technique will be used per IFU | Device | 2 |
| Fluoroscopy guided transforaminal epidural steroid injection (TFESI)Also: TFESIInjection of steroid solution into the lumbar level | Drug | 1 |
Primary outcome
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
5 secondary outcomes
Functional status change evaluated using the Oswestry Disability Questionnaire.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
General health status change determined using the SF-36.
Time frame: 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).
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Subject global satisfaction post-procedure assessed using a global satisfaction statement.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Change in frequency and type of pain medication use.
Time frame: 6 weeks, 3 mos., 6 mos., 1 year, 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Gerzten, MD principal investigator
Univ. of Pittsburgh Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perc-DLR/Perc-DLG and Fluoroscopy guided transforaminal epidural steroid injection (TFESI) in people with Radicular Pain, run by ArthroCare Corporation at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.