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. 2005 Mar 1;5(4):1–78.

Table 11: Middleton et al.

Spinal Cord Stimulation (Neurostimulation):
An Accelerated Systematic Review
Author Middleton et al.
Agency Australian Safety and Efficacy Register of New Interventional Procedures Surgical (ASERNIP-S)
Date June 2003
Objective To assess the effectiveness and safety of spinal cord stimulation by an accelerated systematic review.
Search Up to April 2003, MEDLINE, Pre-MEDLINE, The Cochrane Library, Issue 2, 2003
Inclusion criteria Randomized controlled trials
Outcome Pain or pain relief
Results: Effectiveness 9 randomized controlled trials including:

  • 1 with failed back surgery syndrome (20;69;78)

  • 1 with complex regional pain syndrome (72;79;80)

  • 1 with painful diabetic neuropathy (58)

  • 2 with critical limb ischemia (not applicable to MAS systematic review)

  • 4 with angina trials (not applicable to MAS systematic review)

Failed back surgery syndrome:

  • North et al. (20;69;78) as reported in Mailis-Gagnon et al. (51) and Cameron, (49).


Complex regional pain syndrome:

  • Kemler et al. (72;79;80) as reported by Mailis-Gagnon et al., (51); Cameron, (49); Turner, (19); and Grabow, (59).

Painful diabetic neuropathy:

  • Tesfaye et al. (58) reported results from a crossover design study in which 10 patients with neuropathic pain for less than 1 year were treated with active spinal cord stimulation for 2 days and then with placebo stimulation for 2 days.

  • Results indicated significant decrease in pain as measured by the visual analogue scale with active vs. placebo stimulation (P = .004)

Critical limb ischemia and angina pain:

  • Not applicable to the Medical Advisory Secretariat’s review
Results: Safety Failed back surgery syndrome:

  • North et al. (20;69;78) did not report safety data

Complex regional pain syndrome:

  • 2 patients with a dural puncture (1 developed a headache)

  • 1 patient with an infection at the implantation site of the pulse generator (IPG) requiring ex-plantation and subsequent reimplantation.

  • 6 patients requiring either plug wound or IPG implantation site revision.

  • 1 patient with a defective lead requiring replacement.

  • 6 episodes of unsatisfactory lead positioning needing correction.

Painful diabetic neuropathy:

  • 2 patients migrated leads requiring reinsertion

  • 2 patients with superficial wound infections requiring antibiotic.

  • 1 patient died due to unrelated causes

Critical limb ischemia:
Adverse events with spinal cord stimulation:

  • 13 lead displacements in 2 years

  • 6 implant failures

  • 3 battery failures

  • 3 cases of infection at the IPG implantation site

  • 1 duodenal perforation

  • 2 cases of nausea

  • 1 case of pruritus

Adverse events with best medical treatment:

  • 3 cases of gastrointestinal bleeding

  • 7 cases of nausea

  • 2 cases of dizziness.
Conclusion reported in the ASERNIP-S Health Technology Assessment

  • Spinal cord stimulation is effective in relieving pain in some of the studies.

  • Spinal cord stimulation appears to be relatively safe although long-term safety and effectiveness of SCS (beyond 2 years) has not been reported in the studies reviewed.