Epidural Spinal Cord Stimulation with a Multiple Electrode Paddle Lead Is Effective in Treating Intractable Low Back Pain

Abstract Introduction Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. There is evidence demonstrating high frequency 10kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with Failed Back Surgery Syndrome (FBSS) but there is limited evidence in CNLBP without prior surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10kHz SCS for this population. Methods This is a multicentre double-blind randomised sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10kHz SCS plus usual care (intervention group) or sham 10kHz SCS plus usual care (control group) after full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. Primary outcome will be a 7 day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6-months adjusting for baseline outcome scores. Incremental cost per quality adjusted life year (QALY) will be calculated at 6-months and over the patient lifetime. Discussion The outcomes of this trial will inform clinical practice and healthcare policy on the role of high frequency 10kHz SCS for patients with CNLBP without prior surgery.

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Staggered Transverse Tripoles With Quadripolar Lateral Anodes Using Percutaneous and Surgical Leads in Spinal Cord Stimulation

Neurosurgery ◽

10.1227/neu.0b013e31827d0e12 ◽

2012 ◽

Vol 72 (3) ◽

pp. 483-491 ◽

Cited By ~ 10

Author(s):

Vishwanath Sankarasubramanian ◽

Jan R. Buitenweg ◽

Jan Holsheimer ◽

Peter H. Veltink

Keyword(s):

Spinal Cord ◽

Low Back Pain ◽

Back Pain ◽

Spinal Cord Stimulation ◽

Dorsal Column ◽

Low Back ◽

Electrode Arrays ◽

Selective Activation ◽

Improved Performance ◽

Lead Configuration

Abstract BACKGROUND: In spinal cord stimulation for low-back pain, the use of electrode arrays with both low-power requirements and selective activation of target dorsal column (DC) fibers is desired. The aligned transverse tripolar lead configuration offers the best DC selectivity. Electrode alignment of the same configuration using 3 parallel percutaneous leads is possible, but compromised by longitudinal migration, resulting in loss of DC selectivity. This loss might be repaired by using the adjacent anodal contacts on the lateral leads. OBJECTIVE: To investigate if stimulation using adjacent anodal contacts on the lateral percutaneous leads of a staggered transverse tripole can restore DC selectivity. METHODS: Staggered transverse tripoles with quadripolar lateral anodes were modeled on the low-thoracic vertebral region (T10–T12) of the spinal cord using (a) percutaneous lead with staggered quadripolar lateral anodal configuration (PERC QD) and (b) laminotomy lead with staggered quadripolar lateral anodal configuration (LAM QD), of the same contact dimensions. The commercially available LAM 565 surgical lead with 16 widely spaced contacts was also modeled. For comparison with PERC QD, staggered transverse tripoles with dual lateral anodes were modeled by using percutaneous lead with staggered dual lateral anodal configuration (PERC ST). RESULTS: The PERC QD improved the depth of DC penetration and enabled selective recruitment of DCs in comparison with PERC ST. Mediolateral selectivity of DCs could not be achieved with the LAM 565. CONCLUSION: Stimulation using PERC QD improves anodal shielding of dorsal roots and restores DC selectivity. Based on our modeling study, we hypothesize that, in clinical practice, LAM QD can provide an improved performance compared with the PERC QD. Our model also predicts that the same configuration realized on the commercial LAM 565 surgical lead with widely spaced contacts cannot selectively stimulate DCs essential in treating low-back pain.

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