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NCT00205855 · ClinicalTrials.gov registry record · Phase 3
An Implantable Spinal Cord Stimulation Pain Management System
A Phase 3 study of Pain and Chronic Pain, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
- 9
- Study locations
NCT00205855: Completed Phase 3 study of Pain and Chronic Pain, sponsored by Boston Scientific Corporation.
NCT00205855 is a Phase 3 study of Pain and Chronic Pain that has completed, run by Boston Scientific Corporation. The registered enrollment target is 65 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (79% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00205855, a Phase 3 study of Pain and Chronic Pain, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
- 9
- Study locations
Study Summary
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.
Primary Outcome
The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
Conditions Studied
Interventions
- DEVICE Precision SCS
Study Locations (9)
Texas
- Dallas Neurological Associates - Dallas
- River Oaks Pain Management - Houston
- Texas Back Institute - Plano
California
- California Pain Medicine Centers - Los Angeles
- Pacific Pain Treatment Center - San Francisco
Alabama
- Alabama Pain Center - Huntsville
Montana
- Yellowstone Neurological Associates - Billings
New York
- Northshore University Hospital - Syosset
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2003-02 |
| Est. Completion | 2005-03 |
| Phase | Phase 3 |
What the finished NCT00205855 record still lists
NCT00205855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (79% lower).
The record links to 5 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Precision SCS is the first listed.
NCT00205855 lists 9 locations in 6 states (Texas, California, Alabama).
Frequently Asked Questions
What is clinical trial NCT00205855 about?
NCT00205855 is a clinical study titled "An Implantable Spinal Cord Stimulation Pain Management System". There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay...
What is the current status of trial NCT00205855?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2003-02. Estimated completion is 2005-03.
What conditions does trial NCT00205855 study?
This clinical trial studies the following conditions: Pain, Chronic Pain, Back Pain, Pain, Intractable, Failed Back Surgery Syndrome.
What interventions are being tested in trial NCT00205855?
The interventions under investigation include: Precision SCS (DEVICE).
Who is sponsoring clinical trial NCT00205855?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00205855 being conducted?
This trial has 9 study locations across Alabama, California, Montana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00205855's enrollment target sits among peer trials
65 221st of 374 higher than 154 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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