Introduction: It was previously identified that the majority of patients experience uncomfortable stimulation associated with posture changes, especially when lying down. Position-adaptive neurostimulation was designed to accommodate for positional changes and eliminate the need to manually adjust the stimulation parameters. The purpose of this study was to establish the extent that chronic pain patients implanted with surgical, laminectomy-type leads experience position-related variations in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
Methods: A total of 18 patients completed a single-center, prospective, randomized feasibility clinical study with a two-arm crossover design.
Results: A two-tailed Wilcoxon signed-ranks test at significance level of 0.05 indicated statistically significant amplitude differences in all body positions for automatic (p<0.013) and manual (p<0.001) stimulation when stimulation intensity in the supine body position was compared to all the other body positions.
Clinical outcomes improved significantly at all time points for ODI (p=.0039), VAS leg (p=.0082), Pittsburg Sleep Quality Index, (p=.034), and at 2 months for VAS back pain scores compared with baseline scores. There were no statistically significant changes in pain medication scores (p=.73). In addition, we did not detect any statistically significant differences for medication use (6.8 vs. 6.6; p=.77), ODI, (33.4 vs. 31.5; p=.28), VAS for back (4.3 vs. 3.5; p=.16) or leg pain, (3.3 vs. 3.3; p=1.0), and PSQI (8.9 vs. 8.6; p=.65) scores in manual vs. automatic patient groups. The patients reported higher Likert scale satisfaction rates with automatic stimulation (mean 1.7; 95% CI = 1.1 – 2.3).
Conclusions: Similar variations were reported for manual or automatic stimulation intensity in response to positional changes, but the patients were much more satisfied when using position-adaptive stimulation for relief of their back and leg pain.
Patient Care: This prospective, randomized clinical study clearly demonstrated significantly higher patient satisfaction scores when using position adaptive SCS.
Learning Objectives: By the conclusion of this session, participants should be able to:
1) Describe the convenience of position-adaptive vs. manual spinal cord stimulation