Spinal cord stimulation with interleaved pulses: a randomized, controlled trial.

Objectives. The development of multicontact electrodes and programmable, implanted pulse generators has increased the therapeutic success of spinal cord stimulation (SCS) by enhancing the ability to capture and maintain pain/paresthesia overlap. This study sought to determine if interleaved stimulation and/or frequency doubling improves pain/paresthesia overlap in patients with failed back surgery syndrome. Methods. Using a patient-interactive computer system that quantifies SCS performance and presents stimulation settings in randomized, double-blind fashion, we compared the effect on pain/paresthesia overlap of interleaved stimulation (rapidly interleaved pulse trains using two different contact combinations) vs. standard treatment with a single contact combination, controlling for frequency doubling. Stimulation amplitude (charge per phase, as determined by varying pulse voltage or width) was adjusted to a subjectively comfortable intensity (usage amplitude), which was maintained for all trials in each patient. The number of percutaneous spinal electrodes used (one or two) and the phase angle between interleaved pulses were additional study variables. Results. Multivariate analysis of 266 test results from 15 patients revealed a statistically significant (p ≤ 0.05) association between increased computer-calculated pain/paresthesia overlap and 1) high- and low-frequency interleaved stimulation using two combinations of contacts and 2) frequency doubling using one combination. We found no significant effect for electrode configuration (single or dual), pulse width matching, or phase angle. Conclusions. The statistically significant advantages we observed for SCS with interleaved stimulation are explained, at least in part, by the effects of frequency doubling. These findings have important implications for the design and adjustment of pulse generators.

Spinal cord stimulation for axial low back pain: a prospective controlled trial comparing 16-contact insulated electrodes with 4-contact percutaneous electrodes.

Use of multicontact electrodes and programmable implanted pulse generators has increased the efficacy of spinal cord stimulation for pain. Some investigators find dual column electrodes advantageous for difficult-to-treat axial low back pain, but we have reported significantly improved measures with a single percutaneous midline electrode vs. dual percutaneous electrodes and even better results with an insulated, 1 × 4, midline electrode. In this study, 10 patients provided computerized, quantitative parameter measures for a temporary percutaneous 1 × 4 electrode and for a permanent insulated 2 × 8 electrode. Compared with the 2 × 8, the 1 × 4 resulted in marginally better patient-rated (109%, p = 0.06) and computer-calculated pain/paresthesia overlap (107%, p = 0.17); higher scaled amplitude to cover the low back (106%, NS); and significantly lower voltage (78%, p = 0.0004), increased extraneous coverage (141%, p = 0.0000), and improved symmetry (25%, p = 0.001). Thus, we observed no significant technical advantage for the insulated 2 × 8 in treating axial low back pain.

Spinal cord stimulation electrode design: a prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: part II-clinical outcomes.

OBJECTIVE: Spinal cord stimulation, in use for more than 30 years, has evolved into an easily implemented technique involving percutaneous or laminectomy electrode placement. In a randomized comparison of four-contact percutaneous and four-contact insulated laminectomy electrodes placed at the same level in the dorsal, epidural midline, quantitative measures of stimulator performance revealed significant technical advantages for the laminectomy electrodes. Our prospective, randomized, controlled trial compares clinical results in these same patients. METHODS: Impartial third parties followed our series of 24 patients with failed back surgery syndrome to gather clinical outcome data. We defined "success" as at least 50% sustained relief of pain and patient satisfaction with the result of treatment. RESULTS: At a mean follow-up of 1.9 years, 10 of 12 patients receiving the laminectomy electrode and 5 of 12 patients receiving the percutaneous electrode reported a successful outcome (P < 0.05). Follow-up at a mean of 2.9 years showed that this result was maintained in 5 of 12 patients with the laminectomy electrode and 3 of 12 with the percutaneous electrode (not statistically significant). Many patients reported improvements in most activities of daily living, and loss of function was rare. In addition, 9 patients with laminectomy electrodes and 4 with percutaneous electrodes reducted or eliminated analgesic intake (P < 0.05), and 2 returned to work. No electrode migration was observed. CONCLUSION: Laminectomy electrode placement, although more invasive than percutaneous placement, yields significantly better clinical results in patients with failed back surgery syndrome at mean 1.9 years follow-up. In our small sample, however, the statistical significance of this advantage disappeared at mean 2.9 years follow-up.

Spinal cord stimulation for axial low back pain: a prospective, controlled trial comparing dual with single percutaneous electrodes.

STUDY DESIGN: A prospective, controlled, clinical trial comparing single and dual percutaneous electrodes in the treatment of axial low back pain from failed back surgery syndrome. OBJECTIVES: To clarify technical requirements and test the hypothesis that placing two linear arrays in parallel, thereby doubling the number of contacts, improves outcome. SUMMARY OF BACKGROUND DATA: Technical improvements have enhanced outcomes of spinal cord stimulation for chronic axial low back pain. Dual, parallel electrodes reportedly improve these outcomes. METHODS: Acting as their own controls, 20 patients who passed screening with single, 4-contact electrodes received permanent dual, 4-contact electrodes with 7- or 10-mm intercontact distances at the same vertebral level(s). We quantified and compared the technical and clinical results of the single and dual electrodes, adjusting stimulation parameters to specific psychophysical thresholds. RESULTS: Single electrodes provided significant (P < 0.01) advantages in patient- and computer-calculated ratings of pain coverage by paresthesias and in the scaled amplitude necessary to cover the low back, compared with dual 7-mm electrodes. Slight advantages without statistical significance were observed for the single over the dual 10-mm electrodes. Amplitude requirements were significantly lower for the single electrode than for either dual electrode. At long-term follow-up, 53% of patients met the criteria for clinical success. CONCLUSIONS: While we observed disadvantages for dual electrodes in treating axial low back pain, we achieved technical success with single or dual electrodes in most patients and maintained this success clinically with dual electrodes in 53%.

Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial.

OBJECTIVE: Persistent or recurrent radicular pain after lumbosacral spine surgery is often associated with nerve root compression and is treated by repeated operation or, as a last resort, by spinal cord stimulation (SCS). We conducted a prospective, randomized, controlled trial to test our hypothesis that SCS is more likely than reoperation to result in a successful outcome by standard measures of pain relief and treatment outcome, including subsequent use of health care resources. METHODS: For an average of 3 years postoperatively, disinterested third-party interviewers followed 50 patients selected for reoperation by standard criteria and randomized to SCS or reoperation. If the results of the randomized treatment were unsatisfactory, patients could cross over to the alternative. Success was based on self-reported pain relief and patient satisfaction. Crossover to the alternative procedure was an outcome measure. Use of analgesics, activities of daily living, and work status were self-reported. RESULTS: Among 45 patients (90%) available for follow-up, SCS was more successful than reoperation (9 of 19 patients versus 3 of 26 patients, P <0.01). Patients initially randomized to SCS were significantly less likely to cross over than were those randomized to reoperation (5 of 24 patients versus 14 of 26 patients, P=0.02). Patients randomized to reoperation required increased opiate analgesics significantly more often than those randomized to SCS (P <0.025). Other measures of activities of daily living and work status did not differ significantly. CONCLUSION: SCS is more effective than reoperation as a treatment for persistent radicular pain after lumbosacral spine surgery, and in the great majority of patients, it obviates the need for reoperation.

Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes.

OBJECTIVE: The clinical use of spinal cord stimulation for treatment of chronic intractable pain has been increasingly successful because of recent technical improvements, particularly the development of multiple-contact electrodes supported by programmable implanted pulse generators. Contemporary electrodes can be placed percutaneously in some cases and require a limited laminectomy in other cases. METHODS: We performed a prospective, randomized, controlled trial comparing two prototypical electrode designs, using a computerized system that allows direct patient interaction and quantitative measurements. A series of 24 patients with chronic lumbosacral pain syndromes first underwent testing with percutaneous four-contact electrodes and then underwent implantation, at the same spinal level, of one of two different electrode configurations; 12 patients received a new percutaneous four-contact electrode of the same design and 12 received an insulated four-contact array, which was implanted via laminectomy. RESULTS: The insulated array performed significantly (P = 0.0005-0.0047) better than the temporary percutaneous electrode for the same patients, according to all three measures tested (ratings of paresthesia coverage of pain, coverage calculated from patient drawings, and amplitudes), at the "usage" amplitude for the three standard bipoles examined. The insulated array also performed significantly (P = 0.0000-0.026) better than the permanent percutaneous electrode in terms of coverage ratings and amplitude requirements. Low back coverage ratings were significantly better for the insulated array than for the temporary percutaneous electrode, and scaled amplitudes necessary for low back coverage were significantly better for the permanent percutaneous electrode than for the temporary electrode. In comparison with the percutaneous temporary electrode, at subjectively identical stimulation intensities, the permanent insulated array required significantly lower amplitude. CONCLUSION: We can immediately infer from these technical data that the use of an insulated array, in comparison with a percutaneous electrode, would double battery life. Extended follow-up monitoring will be required to assess the extent to which the technical advantages we observed for the insulated array might be associated with improved clinical outcomes.

Specificity of diagnostic nerve blocks: a prospective, randomized study of sciatica due to lumbosacral spine disease.

Temporary nerve blocks using local anesthetic are employed extensively in the evaluation of pain problems, particularly lumbosacral spine disease. Their specificity and sensitivity in localizing anatomic sources of pain have never been studied formally, however, and so their diagnostic and prognostic value is questionable. There have been anecdotal reports of relief of pain by temporary blocks directed to areas of pain referral, as opposed to areas of documented underlying pathology; but there has been no study to define the frequency or magnitude of this effect. We have examined the specificity and sensitivity of a battery of local anesthetic blocks in a series of 33 patients with a chief complaint of sciatica, attributable in all cases to spinal disease (radiculopathy, with some clinical features of arthropathy). As determined by blinded patient analog ratings in randomized sequence, three different nerve blocks were significantly more effective than control lumbar subcutaneous injection of an identical volume of 3 ml of 0.5% bupivacaine (P < 0.05). Not only paraspinal lumbosacral root blocks and medial branch posterior primary ramus blocks (at or proximal to the pathology), but also sciatic nerve blocks (distal or collateral to the pathology) produced temporary relief in a majority of patients. This confirmed the study hypothesis that false positive results are common, and specificity is low. For sciatic nerve blocks, specificity was between 24% and 36%. Patterns of responses specific to the established diagnosis of radiculopathy (i.e., root block most effective) had sensitivities between 9% and 42%. Statistical analysis of clinical and technical prognostic factors revealed that the only association with pain relief by any block were the effects of other blocks. The strongest association was between relief by sciatic nerve block and relief by medial branch posterior primary ramus (facet) block (P = 0.001, odds ratio 16.0). There were no associations between the results of blocks and clinical findings (history, physical examination, diagnostic imaging) in these patients, chosen for their homogeneous clinical presentation and absence of functional signs. Our findings indicate a limited role for uncontrolled local anesthetic blocks in the diagnostic evaluation of sciatica and referred pain syndromes in general. Negative blocks or a pattern of responses may have some predictive value, but isolated, positive blocks are non-specific. This lack of specificity may, however, be advantageous in therapeutic applications.

Radiofrequency lumbar facet denervation: analysis of prognostic factors.

Percutaneous radiofrequency lumbar facet denervation has been in use as a treatment for intractable, mechanical low back pain for over 2 decades. A number of case series have been reported with high rates of success in selected patients; however, there has been limited objective outcome assessment, long-term follow-up, and analysis of prognostic factors. We have reviewed our experience with diagnostic lumbar facet blocks and percutaneous radiofrequency denervation at a mean follow-up interval of 3.2 years. Long-term outcome has been assessed by disinterested third party interview. Of 82 patients selected for these procedures, 56 had undergone prior low back surgery. Following diagnostic medial branch posterior primary ramus blocks, 42 reported at least 50% relief of pain and proceeded to radiofrequency denervation. Forty-five percent of patients undergoing denervation reported at least 50% relief of pain at long-term follow-up. Among the 40 patients who only underwent temporary blocks, 13% reported relief (i.e., spontaneous improvement or placebo effect) by at least 50% at long-term follow-up). By multivariate statistical analysis, patients undergoing bilateral blocks for bilateral or axial symptoms were significantly more likely to achieve temporary relief, and to proceed to permanent denervation. There was no difference, however, between the long-term results of bilateral denervation for bilateral or axial pain and those of unilateral denervation for unilateral pain. There was no significant difference in the rate of response between the 56 patients who had undergone prior lumbosacral spine surgery and the 26 who had not. There were no complications from the procedure.(ABSTRACT TRUNCATED AT 250 WORDS)