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

Publication Information

Author(s): North RB, Kidd DH, Olin J, Sieracki JN, Petrucci L.
Journal: Neuromodulation
Volume, issue, pages: 9(1):56-67
Year: 2006
PubMed Link: http://www.ncbi.nlm.nih.gov/pubmed/22151594

Study description

Study design: Non-randomized, prospective, controlled trial
Study question: What is the comparative efficacy of 16-contact, 2-column surgical paddle and 4-contact percutaneous electrodes?
Population assessed: Human. Trialed and implanted.
Follow-up duration: Acute study
Other efforts to reduce bias: Patient interacted directly with computer
Patient protection: IRB, informed consent
Outcome measures: VAS ratings of coverage; calculations from patient drawings; ratios scaled to range from perception to discomfort
Primary outcome: VAS rating of coverage of low back
Secondary outcomes: Power requirements; extraneous coverage; symmetry
Statistical significance: P < 0.05
Statistical analyses performed: Paired t-tests; ANOVA

Patient selection

Inclusion criteria: FBSS patients with predominant axial low back pain; successful trial with percutaneous 1x4
Exclusion criteria: Described
Pre-op diagnostic imaging: Yes
Diagnosis required: Yes
Organic pain origin required: Yes
Psychological evaluation: Yes

Demographic / prognostic factors

Pain location

Back only or predominant: 10

Pain characteristics

Indications (trial/implant)

Failed back surgery syndrome: 10

Screening trial

Number patients who underwent trial: 25, of whom 16 passed trial and 10 consented to participate in study
Trial electrode type: Percutaneous 1x4
Trial electrode manufacturer: Medtronic 3487A
Trial technique: Described
Trial success criteria: 50% reduction of pain despite activity on stable or reduced analgesics
Trial duration (days): 3 day minimum

Stimulation

Paresthesia coverage: VAS rating, calculated by computer from patient drawings
Paresthesia threshold: Perceptual, bilateral, usage, low back, discomfort
Stimulation programming methods: Computerized, patient-interactive, randomized order of presentation
Parameters: 60 Hz, 500 microsec pulse width

System implantation

Number implanted: 10
Type(s) of implanted electrode(s): 16-contact (2x8) paddle electrode
Manufacturer: ANS Lamitrode 88
Anesthesia: Local
Electrode implantaton method: Described
Electrode location(s): T9 to T10 typically

Outcomes

Number in study: 10
Number followed: 10
Number lost to follow-up: 0
Number with stimulation complication: 0
Number died: 0
Answer to study question: No statistically significant advantages for 2x8 over 1x4; marginally superior VAS coverage with 1x4; significantly lower power requirements, more extraneous coverage, and better symmetry for 1x4.

Outcomes: pain

Other beneficial outcomes

Biological complications

Device complications

Stimulation side effects

Extraneous paresthesia: Significantly more (141%) with 1x4 percutaneous electrode

Cost effectiveness

Faculty and staff

Physician experience: Neurosurgeon
Facility location: Baltimore, USA
Facility type: University hospital

Data extraction information