Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING).

BACKGROUND: The prevalence of sacroiliac joint pain (SIJP) is estimated to be 10-30% in patients with chronic low back pain. Numerous conservative and surgical treatment modalities for SIJP have been described with limited evidence regarding long-term pain relief. Spinal cord stimulation (SCS) is a well-established technique to treat patients with chronic low back pain. However, the effect on patients with SIJP is not consistent. Therefore, peripheral nerve stimulation (PNS) for chronic SIJP was implemented in experimental trials. Clinical data on PNS for SIJP is still lacking. The authors present a case series and a protocol for a prospective, multicenter study to determine the effect of PNS in patients with chronic intractable SIJP. METHOD: A multicenter, prospective randomized controlled trial was designed. Patients with chronic intractable SIJP will be recruited and randomized in a 4:3 ratio to either the peripheral nerve stimulation group or to the best medical treatment group. A total of 90 patients are planned to be enrolled (52 in the PNS group and 38 in the BMT group). Patients in the intervention group receive a percutaneous implantation of a unilateral or bilateral lead which is externalized for a trial phase for 3-14 days. After trial phase only patients with at least 50% reduction of pain receive an impulse generator for permanent stimulation. Regular visits for participants are planned on day 0, after 3 months (± 30 days), 6 months (± 30 days), and 12 months (± 60 days). The primary outcome measurements is the difference in Numeric Pain Rating Scale (NRS) between baseline and after 6 months. Secondary outcomes is improvement of pain associated disability (ODI) and improvement of health-related quality of life after 6 and 12 months. DISCUSSION: We have described the protocol for a prospective, multicenter, randomized trial evaluating the influence of PNS on patients with chronic sacroiliac joint syndrome. We believe that PNS on patients with chronic sacroiliac joint syndrome will show promising results regarding pain relief and quality of life in comparison to BMT after 12 months. The design of this trial promises high evidence in comparison to the data to date. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05357300. Registered on April 26, 2022.

Peripheral nerve stimulation for the treatment of chronic knee pain.

The average age of our population is increasing, resulting in a high incidence of chronic degenerative knee pathologies. Several treatment options, including surgical procedures are available to help mitigate these pathologies. However, the percentage of subjects with chronic post-surgical knee pain is still estimated at 16-20%. Neuromodulation techniques such as spinal cord stimulation and dorsal root ganglion stimulation (DRGS) are treatment options for subjects with chronic knee pain. The evidence for peripheral nerve stimulation (PNS) is minimal due to a limited number of neuromodulation systems capable of targeting the distal part of the lower limbs. This study aimed to investigate the safety and efficacy externally powered PNS systems for the treatment of chronic intractable knee pain targeting the saphenous nerve. Patients suffering from chronic intractable post-surgical knee pain received landmark-guided peripheral nerve stimulation of the branches of the saphenous nerve. All implants were performed with an externally powered PNS system to avoid lead migration as a result of cross-joint lead positions tunneling towards an Implantable Pulse Generator to the trunk. Data were collected retrospectively. Subject-reported outcome was measured via numerical rating scale values on a 10-point scale measuring pain intensity at rest and in motion. Additional data were collected for the subjects treated at the Charité location, including quality of life with the SF-36 form, quality of sleep with the Pittsburgh Sleep Quality Index and mood states with the short form of the General Depression Scale. Thirty-three patients received direct to permanent implant, landmark-guided peripheral nerve stimulation of the saphenous nerve branches. Six (18.2%) subjects reported non-sufficient initial benefit from the therapy and were explanted. Two subjects were explanted due to wound infections. The total study population reported included 25 patients. These subjects reported significant improvements related to pain, quality of life, mood quality, and quality of sleep. Additionally, subjects were able to reduce their opioid medication significantly after PNS therapy. Externally powered PNS at the saphenous nerve branches is a straightforward, selective and safe technique for patients with chronic knee pain. The landmark-guided implantation technique is less invasive than classical neuromodulation techniques such as spinal cord or DRGS and complication rates remain low. Short-term results are promising and show considerable reductions in pain scores and opioid intake. Long-term results are pending.

Spinal Cord Stimulation: A Reasonable Alternative Treatment in Patients With Symptomatic Adult Scoliosis for Whom Surgical Therapy Is Not Suitable? A Pilot Study.

INTRODUCTION: In adult scoliosis, dorsal instrumentation and fusion can provide significant improvement of pain and disability scores (Owestry Index); however, complication rates of up to 39% have been reported. As such, recent attempts have been made at expanding the surgical spectrum to include less invasive techniques in patients such as neuromodulation, specifically spinal cord stimulation (SCS). We therefore aimed to evaluate its use in a larger cohort of adult scoliosis patients in the form of a pilot study. MATERIALS AND METHODS: We analyzed prospectively collected data from 18 adult scoliosis patients receiving SCS treatment in our institution between February 2019 and May 2020. Clinical follow-up was performed at 3, 6, and 12 months following implantation of an epidural SCS System. Patients reported numeric rating scale (NRS) values for the categories of lower back pain (LBP) and regional pain (RP) both at rest and in motion. Further, SF-36, ADS-K, PSQI, and ODI forms were completed. The study was approved by the institutional Ethics Committee (EA2/093/13). RESULTS: Initial preoperative NRS of LBP at rest was significantly reduced following SCS at three (45% reduction, p = 0.005) and six (43% reduction, p = 0.009) months follow-up. LBP in motion was also reduced at three (27% reduction, p = 0.002) and six (33% reduction vs. preoperative, p = 0.005) months. RP at rest was reduced at three (38% reduction, p = 0.003) and six (37% reduction, p = 0.007) and in movement at three (29% reduction, 0.006) and six (32% reduction, p = 0.011). Loss of thoracic kyphosis and increased pelvic incidence were associated with worse NRS response to SCS stimulation at six months follow-up. DISCUSSION: In overweight, older adults for whom the risks of corrective surgery must be carefully considered, neuromodulation can significantly reduce LBP as well as regional pain in the first six months following implantation. These findings may provide a reasonable alternative in patients not willing or eligible to undergo extensive corrective surgery.