Twenty-four month data from a postmarket, clinical registry have found that most patients suffering from chronic pain of the trunk and/or limbs reported “substantial” pain relief following implantation of a spinal cord stimulation system. The 24-month clinical outcome study observed significant improvements across all outcome measures, at all follow-up visits.
The longitudinal, multicentre, prospective observational registry study enrolled 614 patients from 39 sites within 30 days of permanent spinal cord stimulation system implantation. Upon enrolment and at three, six, 12, 18 and 24 months, “patient-reported pain relief, categorical ratings of pain relief, pain disability index scores, quality of life and patient satisfaction” results were recorded.
The authors observed that mean patient-reported pain relief “was 58.5% (± 26.4) at three months, 56.8% (± 29.2) at six months, 57.7% (± 28.9) at 12 months, 55.6% (± 29.8) at 18 months, and 56.3% (± 30.3) at 24 months.” Commenting on the distribution of these results, researchers noted that over 65% of patients had reported pain relief of more than 50% at each follow-up appointment. “Mean pain disability index scores reduced from 46.9 points at baseline to 32.7, 31.8, 31.5, 32.1, 32.1 points at three, six, 12, 18, and 24 months (p ≤ 0.0001), respectively,” the authors observed. Seventy-six per cent of patients reported satisfaction with their therapy, while “the majority of patients categorised pain relief as ‘excellent’ or ‘good’ on a five-item scale”. Quality of life was also reported by most patients as “improved” or “greatly improved”. Narcotic and opioid use was stopped, decreased, or sustained in 88% of patients. Eleven-point-four of patients, however, reported a loss of pain relief during the study.
Given the “substantial pain relief” and “significant improvement” across all outcome measures, at all follow-up visits, the authors reported that “these results further support the safety, efficacy and sustainability of spinal cord stimulation in clinical practice.”
This study was a postmarket, clinical registry sponsored by St Jude Medical. The data were published in the journal Neuromodulation.