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Sponsored by: |
ArthroCare Corporation |
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Information provided by: | ArthroCare Corporation |
ClinicalTrials.gov Identifier: | NCT00189605 |
To compare the plasma disc decompression procedure using Coblation technology to selective nerve root injection (SNRI) for treatment of patients with radicular pain originating from a focal disc protrusion by evaluating treatment efficacy and rate of improvement in symptoms through the first six months following completion of treatment.
The principal objectives of this study are to determine whether subjects receiving the plasma disc decompression procedure demonstrate:
Condition | Intervention | Phase |
---|---|---|
Radicular Pain Secondary to Focal Disc Protrusion |
Device: Perc-DLR/Perc-DLG and SNRI |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomized, Multi-Center Clinical Study of Plasma Disc Decompression Efficacy |
Estimated Enrollment: | 120 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2008 |
Chronic back pain is the most common ailment in modern industrial societies. It ranks first among musculoskeletal disorders and is associated with serious financial and social consequences. First line conservative care for treating back pain, which frequently occurs in conjunction with debilitating radicular pain, typically includes one or more trials of bed rest, braces, physical therapy and prescription of opioids or expensive non-steroidal anti-inflammatory drugs (NSAIDs). Even though these are routine therapies, they may not be the optimal solution; opioids may be addictive and patients are likely to develop drug intolerance, NSAIDs have potentially dangerous side effects, and physical therapy may be ineffective. Because chronic back pain and its ineffective treatment are associated with such high societal costs, other methods for treating this disorder effectively have been vigorously pursued.
Plasma disc decompression is based on the principle that inducing a small reduction of volume in a closed hydraulic space, such as an intact (contained herniated) disc, can promote significant relief of pressure, and therefore reduce or eliminate pain. Once intradiscal pressure is relieved, the disc is believed to down-regulate inflammatory mediators, reduce in size, and initiate a healing process, thereby alleviating chemical, mechanical, and neural genesis of discogenic pain. The fluoroscopically guided transforaminal epidural steroid injection technique (also known as selective nerve root injection also known as SNRI) is accepted as a relatively safe, effective technique for treating radicular pain. The SNRI technique delivers a high concentration of corticosteroid to the targeted disc nerve interface; this is thought to decrease pain by reducing the inflammatory process. Past investigation has demonstrated efficacy of SNRI over a sham treatment. As SNRIs for therapeutic use are frequently administered in a series of two or more injections 2-3 weeks apart, the length of time in which patients may ultimately receive pain relief, and the costs associated with multiple injections and the extended recovery period are areas that are not fully understood, nor adequately studied. By contrast, the plasma disc decompression procedure is typically performed only once, with subsequent improvement in patient symptoms.
This study therefore proposes to compare the efficacy of the plasma disc decompression procedure to the standard and usual SNRI series in a patient population who have failed to improve after an initial SNRI injection. Patients will have failed an initial SNRI or epidural steroid injection (ESI).
The goal of this study is to better understand the differences between the treatment efficacies and 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 SNRI or ESI. In addition, patients will continue to be monitored over the 2-year post-procedure period to assess stability of treatment effect.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Peter Gerzten, MD | Univ. of Pittsburgh Medical Center |
Study ID Numbers: | S-704LB |
Study First Received: | September 13, 2005 |
Last Updated: | June 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00189605 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Plasma disc decompression Intradiscal Pressure Nucleoplasty Steroid Injection Epidural Steroid Injection |
Selective Nerve Root Injection Leg Pain Radicular Pain Coblation SNRI |
Neoplasm Metastasis Pain |