Background: There is a dearth in our understanding of the factors that are predictive of successful
spinal cord stimulator (SCS) trials and eventual conversion to permanent implants. Knowledge of
these factors is important for appropriate patient selection and treatment optimization.
Objectives: Although previous studies have explored factors predictive of trial success, few have
examined the role of waveform in trial outcomes. This study sought to establish the relationship of
neuraxial waveform and related measures to trial outcomes.
Study Design: This study used a retrospective chart review design.
Methods: Data were retrospectively collected on 174 patients undergoing SCS trials upon
institutional review board approval of the study protocol. Indications for SCS were: complex regional
pain syndrome, failed back surgery syndrome with radicular symptoms, peripheral neuropathy, and
axial low back pain. Descriptive statistics and logistic regression analyses were used to assess the
association of demographic and clinical variables with SCS trial outcomes.
Results: The study population comprised 56% women, had a median age of 55 (interquartile
range [IQR], 44-64), and 32 of 174 (18%) patients failed SCS trials. Individuals with successful
trials (≥ 50% pain relief) were significantly younger and had a median age of 54 years (IQR, 42-60)
compared to those who failed SCS trials (median age 66 years; IQR, 50-76; P = .005). Adjusting
for age, gender, number of leads, pain category, and diagnoses: surgical history (odds ratio [OR] =
4.4; 95% confidence interval [CI], 1.3-15.8) and paresthesia-based tonic-stimulation (OR = 10.3;
95% CI, 1.7-62.0), but not burst or high frequency, were significantly associated with successful
trials. Of note, the number of leads (whether dual or single), pain duration, characteristics, and
category (nociceptive vs neuropathic) were not significant factors. An interaction between surgical
spine history and lower extremity pain was significantly associated with a positive trial (P = .005).
Limitations: This study was limited by its retrospective nature and focus on a patient population
at a single major academic medical center.
Conclusions: Paresthesia-based tonic stimulation, age, and surgical history have significant
effects on SCS trials. Prospective and randomized controlled studies may provide deeper insights
regarding impact on costs and overall outcomes.
IRB Approval #: 2018P002216
Keywords: Pain duration, pain location, spinal cord stimulator trial, stimulator waveform,
surgical history