Findings of a randomised, prospective study suggest that non-surgical refractory back pain (NSRBP) patients have better outcomes with 10KhZ spinal cord stimulation (SCS) and conventional medical management (CMM), than CMM alone. The study findings were presented as a late-breaking abstract at the North American Neuromodulation Society (NANS) virtual meeting (January 15–16).
CMM includes a number of conventional treatments such as medication, physical therapies, psychiatric therapies, epidural injections, and radio frequencies.
The three-month preliminary endpoint of the study was presented by Leonardo Kapural (Carolinas Pain Institute, Winston-Salem, USA). The secondary endpoint is at six months, and the study includes follow-up at one and two years.
The key findings of this study were that 80.9% of patients who received SCS and CMM had equal to or greater than 50% pain relief; this is compared to patients who received CMM only, where only 1.33% (one patient) had this result. Additionally, patients with SCS saw a change in disability, measured on the Oswestry disability index. At the primary endpoint, the vast majority of SCS patients had dropped from severe disability to moderate disability. For patients with CMM, their levels of disability were largely stagnant.
The focus of the study was on NSRBP patients who have been considered inoperable by spinal surgeons. According to Kapural, the study’s purpose was based on the lack of treatment options for these patients, meaning there is a need for researchers to produce level one evidence of the clinical and cost-effectiveness of 10KhZ SCS.
Patients eligible for the study were those who were not considered good candidates for back surgery, had not had any previous back surgeries, had back pain greater than 5cm on the visual analogue scale (VAS), and had predominantly neuropathic pain. Additionally, Kapural noted that both groups had chronic pain for eight years or more.
Originally 216 patients were enrolled in the study, with enrolment ending early due to prespecified interim analysis showing the study had the ability to meet its primary endpoint sooner than expected. Fifty-two patients failed the screening, so 159 were randomised. The CMM arm had 76 patients initially, but one withdrew so there were 75 at the six-month mark. The other arm was CMM with SCS, with 83 patients enrolled in this group. Three withdrew meaning there were 80 who went to trial. There was a failure rate of 7.5% (six patients) and before implantation, a further six patients withdrew. Therefore, the total number of patients who received the implant was 68.
Of those patients who were responsive to SCS, over 50% achieved 80% or greater pain relief. Furthermore, from a patient perspective, 59.2% of those with CMM saw ‘change’, and for SCS patients, 35.2% said it was ‘a great deal better’, while 33.8% said it was ‘better’.
Kapural commented on the significance of the study, “We should be able to see a significant improvement when it comes to the use of non-opioids as well as opioids long term, and that is what is important for practising pain physicians.”