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. 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. 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. ClinicalTrials.gov, NCT05357300. Registered on April 26, 2022.

中文翻译：

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一项前瞻性、随机、多中心试验的研究方案，旨在调查周围神经刺激对慢性骶髂关节综合征 (SILENCING) 患者的影响

慢性腰痛患者中骶髂关节疼痛 (SIJP) 的患病率估计为 10-30%。已有多种 SIJP 保守治疗和手术治疗方法，但关于长期疼痛缓解的证据有限。脊髓刺激（SCS）是一种治疗慢性腰痛患者的成熟技术。然而，对 SIJP 患者的效果并不一致。因此，在实验试验中实施了周围神经刺激（PNS）治疗慢性SIJP。仍缺乏 PNS 治疗 SIJP 的临床数据。作者提出了一个病例系列和一项前瞻性多中心研究方案，以确定 PNS 对慢性难治性 SIJP 患者的作用。设计了一项多中心、前瞻性随机对照试验。慢性难治性 SIJP 患者将被招募并以 4:3 的比例随机分配到周围神经刺激组或最佳药物治疗组。计划总共招募 90 名患者（PNS 组 52 名，BMT 组 38 名）。干预组的患者接受单侧或双侧导线的经皮植入，并进行为期 3-14 天的试验阶段。试验阶段后，只有疼痛减轻至少 50% 的患者才会接受脉冲发生器进行永久性刺激。计划在第 0 天、3 个月（± 30 天）、6 个月（± 30 天）和 12 个月（± 60 天）后对参与者进行定期访视。主要结果测量是数字疼痛评定量表 (NRS) 基线与 6 个月后之间的差异。次要结局是 6 个月和 12 个月后疼痛相关残疾 (ODI) 的改善以及健康相关生活质量的改善。我们描述了一项前瞻性、多中心、随机试验的方案，评估三七总皂苷对慢性骶髂关节综合征患者的影响。我们相信，与 BMT 相比，12 个月后，慢性骶髂关节综合征患者的 PNS 将在疼痛缓解和生活质量方面显示出有希望的结果。与迄今为止的数据相比，该试验的设计提供了高证据。 ClinicalTrials.gov，NCT05357300。注册于2022年4月26日。