Unité de Stimulation Transcrânienne, Clinique Bretéché, Groupe Elsan, Nantes, 44000, France.
UIC22 et Service Douleur Soins Palliatifs et Soins de Support, Centre Hospitalo-Universitaire (CHU), Nantes, 44930, France.
BMC Palliat Care. 2023 Feb 28;22(1):15. doi: 10.1186/s12904-023-01129-0.
Pain is a common symptom in palliative care cancer patients and is often insufficiently relieved. In recent years, transcranial direct-current stimulation (tDCS) of the motor cortex has been shown to be effective to treat chronic pain, essentially neuropathic pain. We propose to test the efficacy of tDCS in patients experiencing cancer pain in the palliative care setting.
METHOD/DESIGN: This article describes the protocol of a bicentre, randomized, parallel-arm, sham-controlled clinical trial evaluating tDCS in the treatment of palliative care patients with refractory cancer pain. Seventy patients between the ages of 18 and 80 years experiencing refractory pain with a pain score of 4/10 on a numerical rating scale (NRS) ranging from 0 to 10 will be enrolled in this trial. The main exclusion criteria are patients unable to fill in the various rating scales and life expectancy less than 3 weeks. Treatment consists of 5 consecutive tDCS sessions targeting the motor cortex (one daily session for 5 days) on the contralateral side to the pain. After randomization (1:1 ratio), 35 patients will receive active stimulation and 35 patients will receive sham stimulation. The primary endpoint is the NRS score and the primary objective is a significant improvement of this score between the baseline score recorded between D-3 and D-1 and the score recorded 4 days after stopping treatment (D8). The secondary objectives are to evaluate whether this improvement is maintained 16 days after stopping treatment (D21) and whether the following scores are improved on D14 and D21: Brief Pain Inventory, Edmonton Symptom Assessment System, Hospital Anxiety and Depression scale, State-Trait Anxiety Inventory and Medication Quantification Scale.
Positive results of this trial would indicate that tDCS can improve pain and quality of life of cancer patients in the palliative care setting. Reduction of analgesic consumption and improvement of activities of daily living should allow many patients to return home with a decreased workload for caregivers.
疼痛是癌症姑息治疗患者的常见症状，且往往得不到充分缓解。近年来，研究表明，经颅直流电刺激（tDCS）刺激运动皮层可有效治疗慢性疼痛，主要是神经病理性疼痛。我们拟在姑息治疗中伴有癌痛的患者中测试 tDCS 的疗效。
方法/设计：本文介绍了一项双中心、随机、平行臂、假对照临床试验的方案，该试验评估 tDCS 治疗难治性癌痛姑息治疗患者的效果。该试验纳入 70 例年龄在 18 至 80 岁之间、疼痛评分在 NRS（0 至 10 分，数字评分量表）上为 4/10 的难治性疼痛患者。主要排除标准为患者无法填写各种评分量表且预期寿命不足 3 周。治疗包括 5 次连续的 tDCS 治疗，针对对侧运动皮层（每天一次，连续 5 天）。随机分组（1:1 比例）后，35 例患者接受真刺激，35 例患者接受假刺激。主要终点为 NRS 评分，主要目标是在基线评分（D-3 至 D-1 之间记录）和治疗结束后 4 天（D8）记录的评分之间，该评分有显著改善。次要目标是评估这种改善在治疗结束后 16 天（D21）是否持续，以及在 D14 和 D21 时以下评分是否改善：简明疼痛量表、埃德蒙顿症状评估系统、医院焦虑和抑郁量表、状态特质焦虑量表和药物量化量表。
如果该试验的结果为阳性，表明 tDCS 可改善姑息治疗中癌症患者的疼痛和生活质量。镇痛药物消耗的减少和日常生活活动能力的改善，应能使许多患者在减少照顾者工作量的情况下返回家中。
