Epidural spinal cord stimulation with a multiple electrode paddle lead is effective in treating intractable low back pain.

The objective of this paper is to examine the outcomes of patients with intractable low-back pain treated with epidural spinal cord stimulation (SCS) utilizing paddle electrodes and a radio frequency (RF) stimulator. A multicenter prospective study was performed to collect data from patients suffering from chronic low-back pain. The study was designed to collect data from 60 patients at four centers and examine their outcomes at, or up to two years post implantation. Patients' participation included written responses to a series of preoperative questionnaires that were designed to collect previous surgical history information, leg and low back pain characteristics, and routine demographic information. Outcome measurements included the visual analog scale (VAS), the Oswestry Disability Questionnaire, the Sickness Impact Profile (SIP), and a patient satisfaction rating scale. Data were collected at each site during patient visits or by mail, at approximately six months, 12 months, and 24 months. A total of 44 patients have been implanted with a SCS system at the time of this writing. Follow-up data were available for 41 patients. Preoperatively, all patients reported more than 50% of their pain in the low back. All patients had pain in both their backs and legs. All patients showed a reported mean decrease in their 10-point VAS scores compared to baseline. The majority of patients reported fair to excellent pain relief in both the low back and legs. At six months 91.6% of the patients reported fair to excellent relief in the legs and 82.7% of the patients reported fair to excellent relief in the low back. At one year 88.2% of the patients reported fair to excellent relief in the legs and 68.8% of the patients reported fair to excellent relief in the low back. Significant improvement in function and quality of life was found at both the six-month and one-year follow-ups using the Oswestry and SIP, respectively. The majority of patients reported that the procedure was worthwhile (92% at six months, 88% at one year). No patient indicated that the procedure was not worthwhile. We conclude that SCS proved beneficial at one year for the treatment of patients with chronic low back and leg pain.

Long-term outcome of spinal cord stimulation for chronic pain management.

Study Design. This is a retrospective study on 102 patients subjected to implantation of a spinal cord stimulation system for nonmalignant chronic pain management. The study was conducted through an extensive questionnaire and telephone interviews by a neutral third party. All the patients were implanted with a complete spinal cord stimulation system without a preliminary trial with a temporarily implanted electrode. Diagnostic categories were neuropathic pain, failed back syndrome, spinal cord Injury pain, and miscellaneous. Average follow-up was 3.8 years (6 months to 8 years). Patients were divided in two groups: all the implanted patients in the survey (Group A) and the implanted patients who experienced some degree of pain relief with the stimulation (Group B). Group B (80 patients) closely matches previously published series where an initial temporary screening was performed. Results. Twenty-one percent of the patients never experienced any pain relief. Of the remaining 80, 75% were still using the stimulator. Fifty-one percent of the 80 patients were experiencing good to excellent results and 20% moderate results. There was no reduction over time in the amount of pain relief in patients who initially had at least 75% pain relief. Patients with initial pain relief between 50% and 74% observed a moderate reduction in their pain relief after two years. Patients who initially experienced less than 50% pain relief observed a dramatic reduction in their results in the long term follow-up. Psychological screening contributed to the success of the procedure. Conclusions. With proper medical and psychological screening and with demonstrated initial pain relief, spinal cord stimulation remains an effective modality in the long-term management of severe chronic pain.

Epidural spinal cord stimulation in the management of spasms in spinal cord injury: a prospective study.

Forty-eight spinal cord injury victims were implanted with an epidural spinal cord stimulation system to treat spasms that had not satisfactorily responded to medical therapy. All the patients were at least 6 months after the injury. The protocol included assessment by independent examiners preoperatively and at 3, 6, 12 and 24 months after the implant. Pre- and postoperative data collection included the frequency and severity of the spasms. Combining the frequency and intensity scores into a 'severity' score provided a more accurate clinical picture. No patient observed neurological deterioration following the surgical procedure or the neurostimulation treatment. A statistically significant reduction in the severity of the spasms was observed in the follow-up evaluations, with results that progressively increased in time. It is appears that spinal cord stimulation is an effective and safe alternative in the management of spasms in spinal cord injury victims. Its exact role in relation to intrathecal baclofen infusion and ablative procedures remains to be defined.

Mapping of sensory responses to epidural stimulation of the intraspinal neural structures in man.

A database is presented of sensory responses to electrical stimulation of the dorsal neural structures at various spine levels in 106 subjects subjected to epidural spinal cord stimulation. All patients were implanted for chronic pain management and were able to perceive stimulation in the area of pain. All patients entered in this study were able to reliably report their stimulation pattern. Several patients were implanted with more than one electrode array. The electrode arrays were placed in the dorsal epidural space at levels between C-1 and L-1. The structures that were likely involved include the dorsal roots, dorsal root entry zone, dorsal horn, and dorsal columns. At the present time, exact characterization of the structure being stimulated is possible only in limited instances. Various body areas are presented with the correspondent spine levels where implanted electrodes generate paresthesias. Areas that are relatively easy targets for stimulation are the median aspect of the hand, the abdominal wall, the anterior aspect of the thigh, and the foot. Some areas are particularly difficult to cover with stimulation-induced paresthesias; these include the C-2 distribution, the neck, the low back, and the perineum.

Analysis of parameters for epidural spinal cord stimulation. 1. Perception and tolerance thresholds resulting from 1,100 combinations.

A computerized statistical analysis of 1,100 quadripolar electrode combinations used in epidural spinal cord stimulation therapy for the management of pain was carried out to investigate perception and tolerance thresholds. This analysis showed that the thresholds are higher at high-cervical, mid-cervical, mid-thoracic and low-thoracic spinal levels. It is also higher for the combinations with contacts located in the midline than those implanted laterally. As the contact separation increases, the perception and tolerance thresholds increase in bipolar combinations. Unipolar combinations have the lowest thresholds.

Analysis of parameters for epidural spinal cord stimulation. 2. Usage ranges resulting from 3,000 combinations.

A computerized statistical analysis of 3,000 implanted electrode (multi-contact, quadripolar) combinations for epidural spinal cord stimulation therapy for the management of pain was carried out in three groups: spinal levels (20 different levels, C2-L2), spinal placement (midline and lateral) and contact separation (unipolar, bipolar with a separation of 10, 20 and 30 mm) to investigate the clinically required usage ranges (difference between the perception threshold and tolerance threshold). The usage range is relatively higher at midthoracic levels (T4-T10), and for the combinations located in midline. As the contact separation increases, the usage range increases in bipolar combinations. The usage range of unipolar combinations is higher than that of bipolar combinations with 10 and 20 mm separation, and is less than that of bipolar combinations having a separation of 30 mm.

Analysis of parameters for epidural spinal cord stimulation. 3. Topographical distribution of paresthesiae--a preliminary analysis of 266 combinations with contacts implanted in the midcervical and midthoracic vertebral levels.

As a part of the systematic analysis of parameters involved in electrical epidural spinal cord stimulation therapy, distribution of paresthesiae in accordance with the position of contacts, as related to midline and vertebral level of contacts, was investigated. A preliminary analysis performed for 266 combinations having contacts implanted in the midcervical and low-thoracic vertebral levels showed that the topographical spread of the paresthesiae did not always cover the classical dermatomes. Significant paresthesiae spread was found as follows: C4-midline, unipolar combinations; the hand, forearm and upperarm, bipolar combinations; the hand, forearm; C4-lateral, unipolar combinations: the anterior shoulder, forearm, upper arm and hand, bipolar combinations: the hand, forearm and upper arm; T10-midline, unipolar combinations: the anterior and posterior of thigh, leg, knee, ankle and foot, bipolar combinations: the anterior and posterior thigh, leg, knee and foot; T10-lateral, unipolar combinations: the abdomen, anterior leg, knee and anterior thigh, bipolar combinations: the anterior thigh, anterior leg, knee and foot. This preliminary analysis suggests that more detailed studies would be worthwhile in the investigation of sensory responses to electrical stimulation of the spinal cord with epidural electrodes. Findings from such investigations could also be useful to extend our present anatomical knowledge of central and peripheral sensory neural structures.

Multifactorial analysis of epidural spinal cord stimulation.

In order to provide a data bank to allow a more precise and effective implementation of spinal cord stimulation, a computerized analysis of 1,375 combinations obtained from electrode arrays located in the thoracic and cervical epidural area was performed. 67 electrode arrays implanted in 34 subjects were subjected to analysis. During the stimulation trial, all the available combinations were systematically tested and the results entered into a computerized database. The study was not meant to analyze the clinical results or the indications of epidural spinal cord stimulation. Parameters studied include position of each electrical contact as related to midline, vertebral level of each contact, distribution of stimulation-induced paresthesiae, and electrical parameters (voltage, rate, pulse width, perception threshold, discomfort threshold, usage range). Analysis of the data allow the surgeon (1) to define the characteristics of the stimulation-induced paresthesiae; (2) to define the spectrum of the electrical parameters used to stimulate the spinal cord; (3) to define the population of implanted electrode arrays/contacts; (4) to study objectively how the position of the electrodes within the spinal canal, their vertebral level and the interelectrode distance affect the electrical parameters and the stimulation-induced responses. The multifactorial systematic analysis of such a large number of combinations provides the basis for further developments in the area of electrical stimulation of the nervous system.