Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity
Summary
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8. Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy. There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation.
Description
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels. Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a "well placed single lead will generally perform better than a dual lead." Furthermore, anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites.
This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Intractable Neuropathic Pain
Intervention
Precision for Spinal Cord Stimulation
Location
Pain Management Center
Belleville
Illinois
United States
62226
Status
Terminated
Source
Boston Scientific Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00399841
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:41:34-0400
Clinical Trials
VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation
The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk...
Optimized Programming in Spinal Cord Stimulation (SCS) System
The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.
High-Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients
The purpose of this study is to explore which mode is effective in the management of intractable chronic pain, the high-density stimulation or the conventional stimulation, in patients who...
OPTIONS Spinal Cord Stimulation Programming Parameters
The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
PubMed Articles
Neuropathic pain is one of the common complications after spinal cord injury (SCI), affecting patients' life quality. The molecular mechanism for neuropathic pain after SCI is still unclear. We aimed ...
Extraforaminal Lumbar Nerve Root Stimulation for Neuropathic Pain: A Case Report.
Electrical stimulation of the spinal cord is commonly used to treat neuropathic pain. However, epidural space adhesion caused by previous surgery may interfere with precise electrical lead placement. ...
Burst spinal cord stimulation in peripherally injured chronic neuropathic rats: a delayed effect.
Two well-known spinal cord stimulation (SCS) paradigms, Conventional (Con) and Burst-SCS, are hypothesized to exert their anti-nociceptive effects through different stimulation-induced mechanisms. We ...
Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms.
The field of spinal cord stimulation (SCS) owes its inception to the concept of gate control theory (GCT), put forth by Wall and Melzack in their landmark 1965 paper, which proposed that "control of p...
ANALGESIC EFFECT OF INTRATHECAL BACLOFEN BOLUS ON NEUROPATHIC PAIN IN SPINAL CORD INJURY PATIENTS.
GABA-ergic neurons are widely distributed throughout the central nervous system, including the spinal cord which is important for the transmission of pain impulses to the brain. Here we hypothesized t...
Medical and Biotech [MESH] Definitions
Spinal Cord Stimulation
Application of electric current to the spine for treatment of a variety of conditions involving innervation from the spinal cord.
Myelitis
Inflammation of the spinal cord. Relatively common etiologies include infections; AUTOIMMUNE DISEASES; SPINAL CORD; and ischemia (see also SPINAL CORD VASCULAR DISEASES). Clinical features generally include weakness, sensory loss, localized pain, incontinence, and other signs of autonomic dysfunction.
Spinal Cord Diseases
Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.
Syringomyelia
Longitudinal cavities in the spinal cord, most often in the cervical region, which may extend for multiple spinal levels. The cavities are lined by dense, gliogenous tissue and may be associated with SPINAL CORD NEOPLASMS; spinal cord traumatic injuries; and vascular malformations. Syringomyelia is marked clinically by pain and PARESTHESIA, muscular atrophy of the hands, and analgesia with thermoanesthesia of the hands and arms, but with the tactile sense preserved (sensory dissociation). Lower extremity spasticity and incontinence may also develop. (From Adams et al., Principles of Neurology, 6th ed, p1269)
Spinal Cord Ischemia
Reduced blood flow to the spinal cord which is supplied by the anterior spinal artery and the paired posterior spinal arteries. This condition may be associated with ARTERIOSCLEROSIS, trauma, emboli, diseases of the aorta, and other disorders. Prolonged ischemia may lead to INFARCTION of spinal cord tissue.
