INTRODUCTION:Sacroiliac joint (SIJ) pain comprises up to 30% of cases of mechanical low back pain (LBP), the leading cause of disability worldwide. Despite sacral lateral branch cooled radiofrequency ablation (CRFA) showing efficacy in clinical trials, there is a lack of comparative-effectiveness long-term follow-up. METHODS:In this randomized, multicenter, comparative-effectiveness study, 210 patients with injection-confirmed SIJ pain who responded to prognostic lateral branch blocks were randomly assigned to receive CRFA of the L5 dorsal ramus and S1-S3/4 lateral branches or standard medical management (SMM) consisting of pharmacotherapy, physical therapy, injections, and integrative therapies. Patients were followed up at 1, 3, 6, 9, and 12 months, with participants reporting unsatisfactory SMM outcomes being allowed to crossover (XO) and receive CRFA at 3 months. The primary outcome measure was the mean change in average LBP score on a 0-10 Numeric Rating Scale (NRS), with secondary outcomes including measures of quality of life (QoL) and function. A responder was defined as a participant who experienced a ≥30% or ≥2-point decrease in average daily NRS pain score coupled with a score ≥5 out of 7 (moderately better) on the Patient Global Impression of Change scale. RESULTS:At 12 months, the mean NRS pain score declined from a baseline of 6.4±1.4 to 3.5±2.6, with 57.4% (35/61) of participants in the randomized CRFA cohort experiencing a ≥2-point or 30% decrease in average LBP from baseline. In the crossover cohort, 35/63 (55.6%) subjects had the same experience 12 months following the XO procedure; in the XO group, the mean LBP decreased from 6.1±1.5 to 3.4±2.5. Patients also experienced clinically meaningful improvements in QoL via EuroQoL-5D-5L at 12 months (mean change of +0.22±0.27 in the originally-treated CRFA group and +0.21±0.33 in the XO group). Oswestry Disability Index (ODI) scores also improved by 12.4%±14.7 (CRFA) and 13.7%±17.1 (XO) from baseline at study-end. No serious adverse events related to the CRFA procedure were reported. CONCLUSION:CRFA in patients with SIJ pain provided clinically significant and sustained improvements for 12 months following a single CRFA treatment, regardless of previous SMM treatment. TRIAL REGISTRATION NUMBER:NCT03601949.
Introduction Low back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies. Methods In this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short-term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1–S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0–10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function. Results 3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced > 2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001). Conclusions In patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management. Trial registration number NCT03601949 .
BACKGROUND:There are limited therapeutic options to treat complex regional pain syndrome (CRPS). Spinal cord stimulation and dorsal root ganglion stimulation are proven therapies for treating chronic low limb pain in CRPS patients. There is limited evidence that stimulation of dorsal nerve roots can also provide relief of lower limb pain in these patients.OBJECTIVES:To demonstrate that electrical stimulation of dorsal nerve roots via epidural lead placement provides relief of chronic lower limb pain in patients suffering from CRPS.STUDY DESIGN:Prospective, open label, single arm, multi-center study.SETTING:The study was performed at the Center for Interventional Pain and Spine (Exton, PA), Millennium Pain Center (Bloomington, IL), and the Carolinas Pain Center (Huntersville, NC). It was approved by the Western Institutional Review Board-Copernicus Group Institutional Review Board and is registered at clinicaltrials.gov (NCT03954080).METHODS:Sixteen patients with intractable chronic severe lower limb pain associated with CRPS were enrolled in the study. A standard trial period to evaluate a patients' response to stimulation of the dorsal nerve roots was conducted over 3 to 10-days. Patients that obtained 50% or greater pain relief during the trial period underwent permanent implantation of a neurostimulation system. The primary outcome was the evaluated pain level after 3 months of device activation, based on NRS pain score relative to baseline. Patients were followed up for 6 months after activation of the permanently implanted system.RESULTS:At the primary endpoint, patients reported a significant (P = 0.0006) reduction in pain of 3.3 points, improvement in quality of life, improved neuropathic pain characteristics, improved satisfaction, and an overall perception of improvement with the therapy. Improvements were sustained throughout the duration of the study up to the final 6-month visit.LIMITATIONS:Due to the COVID-19 pandemic occurring during patient enrollment, only 16 patients were enrolled and trialed, with 12 being permanently implanted. Nine were able to complete the end of study evaluation at 6 months.CONCLUSIONS:The results of this short feasibility study confirm the functionality, effectiveness, and safety of intraspinal stimulation of dorsal nerve roots in patients with intractable chronic lower limb pain due to CRPS using commercially approved systems and conventional parameters.
