Department of Anesthesiology and Pain Management, University Pain Clinic Maastricht (UPCM) Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.
Department of Translational Neuroscience, School for Mental Health and Neuroscience (MHeNS), University of Maastricht, Maastricht, the Netherlands.
Trials. 2022 Sep 5;23(1):749. doi: 10.1186/s13063-022-06637-7.
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Within burst stimulation, a recharge pattern is used to prevent buildup of charge in stimulated tissues. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It has been suggested that differences exist between active and passive recharge paradigms related to both efficacy of pain relief and their underlying mechanism of action. Active recharge has been shown to activate both the medial spinal pathway, engaging cortical sensorimotor areas involved in location and intensity of pain, and lateral pathway, reaching brain areas involved with cognitive-emotional aspects of pain. Passive recharge has been suggested to act via modulation of thalamic neurons, which fire in a similar electrical pattern, and thereby modulate activity in various cortical areas including those related to motivational and emotional aspects of pain. The objective of this randomized clinical trial is to assess and compare the effect of active versus passive recharge Burst SCS on a wide spectrum of pain in PSPS Type 2 patients.
This multicentre randomized clinical trial will take place in 6 Dutch hospitals. PSPS Type 2 patients (n=94) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the Pain Catastrophizing Scale (PCS) (primary outcome at 6 months), Numeric Pain Rating Scale (NRS), Patient Vigilance and Awareness Questionnaire (PVAQ), Hospital Anxiety and Depression Scale (HADS), Quality of Life (EQ-5D), Oswestery Disability Index (ODI), Patient Global Impression of Change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.
The BURST-RAP trial protocol will shed light on possible clinical differences and effectivity of pain relief, including emotional-motivational aspects between active and passive burst SCS in PSPS Type 2 patients.
ClinicalTrials.gov registration: NCT05421273 . Registered on 16 June 2022. Netherlands Trial Register NL9194. Registered on 23 January 2021.
脊髓刺激（SCS）已被证明是治疗慢性持续性脊髓疼痛综合征 2 型（PSPS 2 型）患者的有效方法。在 SCS 中传递电荷的方法很重要。其中一种方法是爆发刺激。在爆发刺激中，使用再充电模式来防止刺激组织中电荷的积累。目前有两种爆发波形变体在使用：一种使用主动再充电，另一种使用被动再充电。已经有人提出，主动和被动再充电模式之间存在差异，这些差异与疼痛缓解的效果及其作用机制有关。主动再充电已被证明可以激活内侧脊髓途径，从而使参与疼痛位置和强度的皮质感觉运动区域参与其中，以及外侧途径，从而到达与疼痛的认知情感方面有关的大脑区域。被动再充电被认为是通过调节丘脑神经元来发挥作用的，这些神经元以相似的电模式放电，从而调节包括与疼痛的动机和情感方面有关的皮质区域的活动。本随机临床试验的目的是评估和比较主动与被动再充电爆发 SCS 在 2 型慢性持续性脊髓疼痛综合征患者的广泛疼痛谱上的效果。
本多中心随机临床试验将在 6 家荷兰医院进行。将 94 名 2 型慢性持续性脊髓疼痛综合征患者随机分为接受主动或被动再充电爆发的组。在成功的试验期后，患者将被永久植入。患者在基线、试验后、1 个月、3 个月、6 个月和 12 个月时完成疼痛灾难化量表（PCS）（主要结局，6 个月时）、数字疼痛评分量表（NRS）、患者警觉性和意识问卷（PVAQ）、医院焦虑和抑郁量表（HADS）、生活质量（EQ-5D）、Oswestry 残疾指数（ODI）、患者整体变化印象量表（PGIC）和疼痛 DETECT 问卷（次要结局）。
BURST-RAP 试验方案将阐明主动和被动爆发 SCS 在 2 型慢性持续性脊髓疼痛综合征患者中的可能临床差异和疼痛缓解效果，包括情感动机方面。
ClinicalTrials.gov 注册：NCT05421273。于 2022 年 6 月 16 日注册。荷兰试验注册 NL9194。于 2021 年 1 月 23 日注册。
