At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain
- ✓Be an appropriate candidate for surgery
- ✓Capable of giving informed consent
- ✓Capable and willing to follow all study related procedures
- ✕Inability to operate the system either by self or with a care-giver
- ✕Currently participating or participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study
- ✕Any implanted electrical devices, regardless of whether active or inactive
- ✕Any active implantable device regardless of whether stimulation is ON or OFF
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System
In Brief
A Phase 3 clinical trial evaluating Precision SCS for Chronic Pain and 4 related conditions. Completed, enrolled 65 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.