脊髓刺激治疗慢性脊柱疼痛综合征 II 型患者的疼痛药物逐渐减量：PIANISSIMO 研究的 RCT 研究方案。

Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study.

机构信息

STIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium.

Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.

出版信息

PLoS One. 2024 Aug 12;19(8):e0302842. doi: 10.1371/journal.pone.0302842. eCollection 2024.

DOI:10.1371/journal.pone.0302842

PMID:39133680

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11318931/

Abstract

BACKGROUND

Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program.

METHODS AND DESIGN

A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure.

DISCUSSION

Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05861609. Registered on May 17, 2023.

摘要

背景

脊髓刺激（SCS）可能为治疗难治性持续性脊髓疼痛综合征 II 型（PSPS-T2）患者提供疼痛缓解。尽管有证据表明 SCS 可以降低残疾程度并减少疼痛药物的使用，但只有 25%的患者在接受 SCS 治疗 12 个月后能够完全停止使用疼痛药物。为了应对大量使用疼痛药物的患者的高负担，可以在开始 SCS 治疗之前启动减药方案。目前的目标是研究 SCS 治疗前的疼痛药物减药方案是否会改变 PSPS-T2 患者的残疾程度，与不减药方案相比。

方法和设计

一项三臂、平行组、多中心随机对照试验将纳入 195 名患者，他们将被随机分为（a）标准化疼痛药物减药方案、（b）个性化疼痛药物减药方案或（c）SCS 植入前不减药方案，所有方案的随访期均为植入后 12 个月。主要结局是残疾。次要结局是疼痛强度、健康相关生活质量、参与度、受物质使用影响的领域、焦虑和抑郁、药物使用、心理结构、睡眠、中枢敏化症状和医疗保健支出。

讨论

在 PIANISSIMO 项目中，我们提出了一种通过在 SCS 前提供疼痛药物减药来降低不良反应、药物引起的痛觉过敏、耐受性和依赖性风险的方法。由于缺乏普遍接受的住院减药方法，本研究将评估两种不同的减药方案。如果疼痛药物减药方案在残疾方面被证明比不减药更有效，这将为该患者群体的以患者为中心的护理模式提供更多证据，并为倡导 SCS 前进行疼痛药物减药作为这些患者的新标准治疗指南铺平道路。