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ASIPP Practice Guidelines - Pain Physician

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Manchikanti et al • <strong>ASIPP</strong> <strong>Practice</strong> <strong>Guidelines</strong><br />

66<br />

evidence from well-designed trials without randomization,<br />

single group pre-post, cohort, time series, or matched case<br />

controlled studies. Level IV- limited is defined as evidence<br />

obtained from well-designed non-experimental studies<br />

from more than one center or research group. In addition,<br />

there is overwhelming support from respected authorities<br />

along with clinical evidence and descriptive studies in<br />

support of judicious use of trigger point injections.<br />

Spinal Cord Stimulation<br />

Spinal cord stimulation uses electrical stimulation of spinal<br />

cord to control pain. There are multiple theories regarding<br />

how this effect causes pain control, but the exact<br />

mechanism is still controversial and may be a result of more<br />

than one of these mechanisms. In the United States, the<br />

primary indications for spinal cord stimulation are failed<br />

back surgery syndrome (691, 692), and both sympathetically<br />

maintained and sympathetically independent pain of<br />

complex regional pain syndrome (693-696). However, in<br />

Europe, most interest in spinal cord stimulation has been<br />

in the treatment of chronic intractable angina and pain and<br />

disability due to peripheral vascular disease (697-701).<br />

Spinal cord stimulation, for the clinical control of pain,<br />

was first introduced in 1967 by Shealy et al (702), in response<br />

to the publication of the gate control theory of pain<br />

by Melzack and Wall in 1965 (703).<br />

In the field of spinal cord stimulation (SCS), as with other<br />

interventional techniques in chronic pain management,<br />

there are numerous retrospective studies that promote the<br />

efficacy of spinal cord stimulation, showing approximately<br />

60% efficacy that lasts approximately two years (691, 704-<br />

710). Wetzel et al (704) reviewed the current literature<br />

regarding the treatment of chronic pain in failed back surgery<br />

patients with spinal cord stimulation. Turner et al<br />

(69) also reviewed the literature on spinal cord stimulation<br />

in chronic low back pain in an attempt to perform a<br />

meta-analysis, concluding that this was not possible based<br />

on the characteristics of the literature. They analyzed 39<br />

reports, “all case studies”, concluding that 50% to 60% of<br />

patients with failed back surgery syndrome reported greater<br />

than 50% pain relief with the use of spinal cord stimulation.<br />

North et al (711), in a prospective study, randomized 27<br />

patients into repeat laminectomy or spinal cord stimulation<br />

groups. Even though this is not quite a similar treatment,<br />

the initial results were published after a 6-month<br />

follow-up; crossover between the groups was permitted.<br />

In this study, there was a significantly higher crossover<br />

rate from repeat laminectomy to spinal cord stimulation<br />

(67%) than vice versa (17%). Multiple observational studies<br />

in postlumbar laminectomy syndrome reported 25% to<br />

76% pain relief at various intervals (706-710, 712, 713).<br />

In a prospective, multicenter study of spinal cord stimulation,<br />

Burchiel et al (697) demonstrated its effectiveness in<br />

the management of chronic low back and extremity pain.<br />

The permanent stimulating system was implanted in 182<br />

patients. They reported at least 50% pain relief in 55% of<br />

the patients at 1-year follow-up.<br />

Kemler et al (695) evaluated spinal cord stimulation in<br />

patients with chronic reflex sympathetic dystrophy utilizing<br />

a randomized trial involving patients who had had reflex<br />

sympathetic dystrophy for at least 6 months. Thirtysix<br />

patients were assigned to receive treatment with spinal<br />

cord stimulation plus physical therapy, and 18 were assigned<br />

to receive physical therapy alone. The health-related<br />

quality of life improved in the 24 patients who actually<br />

underwent implantation of a spinal cord stimulator.<br />

Of the 24 patients, 6 had complications that required additional<br />

procedures, including removal of the device in one<br />

patient. Thus, at 6 months, spinal cord stimulation was<br />

successful in 20 of 36 patients (56%); however, since only<br />

24 patients received spinal cord stimulation, this is 20 out<br />

of 24 patients with an 80% success rate.<br />

Tesfaye et al (714) evaluated spinal cord stimulation for<br />

painful diabetic neuropathy in 10 patients who had not responded<br />

to conventional treatment. The electrode was<br />

implanted in the thoracic/lumbar epidural space. Immediate<br />

neuropathic pain relief after connecting the electrode<br />

was measured using a VAS, and exercise tolerance was<br />

assessed on a treadmill. Eight patients had statistically<br />

significant pain relief with an electrical stimulator, and the<br />

system was made permanent. Seven of these eight had<br />

statistically significant relief of pain at three months, and<br />

this relief was sustained in six patients until the end of the<br />

study at 14 months. These six patients used the stimulator<br />

as the sole treatment for their pain with improvement in<br />

their exercise tolerance. They claimed that electrical spinal<br />

cord stimulation offers a new and effective way of relieving<br />

chronic diabetic neuropathic pain, with improvement<br />

in exercise tolerance, in patients with neuropathic<br />

pain who do not respond to conventional treatment.<br />

In addition to the declining success rate, complications also<br />

are common (713). These were predominantly electrode<br />

related problems i.e., migration, fracture, etc. Infection<br />

was less common, even though it was reported in 5% of<br />

<strong>Pain</strong> <strong>Physician</strong> Vol. 4, No. 1, 2001

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