Abstract
BACKGROUND: The effectiveness and long-term outcomes of spinal cord stimulation (SCS) are not fully established, especially considering that data from patients who withdrew from the trial are rarely analysed, which may lead to overestimation of SCS efficacy. We evaluated short- and long-term effects of SCS on chronic pain and perceived health, beyond natural variability in these outcomes. METHODS: In a prospective design, 176 chronic pain patients referred to SCS were evaluated five times (baseline; retest ~6 weeks later; post-SCS trial; 8 and 28 weeks post-permanent implantation). Patients whose SCS trial failed (Temp group) were followed up and compared to those who underwent permanent SCS (Perm group). RESULTS: Analyses revealed a non-linear (U-shaped) trend significantly different between the two groups. In the Perm group, a significant improvement occurred post-SCS implantation in pain severity, pain interference, health-related quality of life and self-rated health, which was followed by gradual worsening and return to baseline values at end of follow-up. In the Temp group, only minor changes occurred in these outcomes over time. On average, baseline and end of follow-up values in the Perm and Temp groups were similar: ~40% in each group exhibited an increase in pain severity over time and 38% and 33%, respectively, exhibited reductions in pain severity over time. CONCLUSIONS: Since the greatest improvement in the outcome measures occurred from baseline to post-SCS trial (T1-T3) followed by a gradual decline in the effect, it appears that SCS may not be effective for the majority of chronic pain patients. SIGNIFICANCE: This longitudinal study evaluated short and long term effects of spinal cord stimulation (SCS) on chronic pain outcome measures, beyond their natural variation in time. Despite significant short term improvements, by the end of the seven months' follow-up, the outcomes in the treatment group (people who received the permanent implantation) were similar to those of the control group (people whose SCS trial failed and did not continue to permanent implantation) suggesting SCS may not be cost-effective for chronic pain patients.