Phase 3
N=65
An Implantable Spinal Cord Stimulation Pain Management System
Chronic Pain · Pain, Intractable · Pain · Back Pain · Failed Back Surgery Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00205855 ↗Enrolled (actual)
65
Serious AEs
18.5%
Results posted
Oct 2012
Primary outcome: Primary: Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. — 35 participants with > 50% VAS improvement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Precision SCS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Oct 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. |
35 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain.
- Be an appropriate candidate for surgery.
- Be capable of giving informed consent.
- Be capable and willing to follow all study related procedures.
Exclusion Criteria
- Have an inability to operate the system either by self or care-giver.
- Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.
- Have any implanted electrical devices, regardless of whether active or inactive.
- Have any active implantable device regardless of whether stimulation is ON or OFF.
Data sourced from ClinicalTrials.gov (NCT00205855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.