■糖尿病周围神经病变(DPN)显著影响患者的生活质量。迄今为止,选择适当的治疗仍然具有挑战性。虽然电针(EA)已显示出有望作为DPN的有效辅助疗法,红外热成像(IRT)被认为是治疗效果的潜在预测指标,两者的证据仍然没有定论。因此,该试验的目标是双重的:确定EA对DPN的疗效,并探讨IRT作为疗效评估辅助客观工具的可行性。
■这项研究是随机设计的,平行,对照试验。它跨越6周的治疗和额外的4周的随访。104名符合条件的参与者将根据疾病的严重程度进行分层:轻度,多伦多临床评分系统(TCSS)评分6-8,中度(TCSS评分9-11),和严重(TCSS得分12-19),每个级别将以1:1的比例随机分为EA组和等待列表组。等待名单组只接受了目前的常规药物治疗,而EA组在常规药物治疗的基础上又接受了12次EA治疗。主要结果指标是神经传导速度(NCV),将在基线和第6周进行测试。临床总有效率,TCSS,中医临床症状评分,患者整体改变印象(PGIC),感兴趣区域的温度(ROI),和物理化学检查将用作次要结果指标。此外,安全性评估将根据试验期间的不良事件进行.
■本研究的预期结果将确定EA是否能提高DPN治疗的疗效,并具有可接受的安全性,并调查不同DPN严重程度的EA疗效差异。此外,它将探讨IRT作为评估DPN治疗有效性的客观指标的可行性。
■ClinicalTrials.gov标识符,NCT06054087。
UNASSIGNED: Diabetic peripheral neuropathy (DPN) affects patients\' quality of life significantly. To date, selecting the appropriate treatment remains challenging. While electroacupuncture (EA) has shown promise as an effective adjunct therapy for DPN, and infrared thermography (IRT) has been considered as a potential predictor of treatment efficacy, the evidence for both remains inconclusive. As such, the objectives of this trial are twofold: to ascertain the efficacy of EA for DPN, and to explore the feasibility of IRT as an adjunctive objective tool for efficacy assessment.
UNASSIGNED: The study was designed as a randomized, parallel, controlled trial. It spanned over 6 weeks of treatment and an additional 4 weeks of follow-up. 104 eligible participants will be stratified for severity of disease: mild with Toronto clinical scoring system(TCSS) score 6-8, moderate (TCSS score 9-11), and severe (TCSS score 12-19), and each level will be randomised in a 1:1 ratio into a EA group and waiting-list group. The waiting-list group received only the current conventional medication, while the EA group received an additional 12 EA sessions on top of the conventional medication. The primary outcome indicators is nerve conduction velocity (NCV), which will be tested at the baseline and week 6. Total clinical efficiency, TCSS, Clinical symptoms score of Traditional Chinese Medicine (TCM), Patient global impression of change(PGIC), Temperature of regions of interest (ROIs), and Physico chemical examination will be used as secondary outcome indicators. In addition, safety assessment will be determined based on adverse events during the trial.
UNASSIGNED: The expected results of this study will determine whether EA improves efficacy in the treatment of DPN with an acceptable safety profile, and investigating variations in the efficacy of EA across different levels of DPN severity. Furthermore, it will explore the viability of IRT as an objective measure for evaluating treatment effectiveness for DPN.
UNASSIGNED: ClinicalTrials.gov identifier, NCT06054087.