School of Traditional Chinese Medicine, Xiamen University Malaysia, Jalan Sunsuria, Bandar Sunsura, Sepang, Selangor, Malaysia.
Medicine (Baltimore). 2021 Dec 10;100(49):e28173. doi: 10.1097/MD.0000000000028173.
Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes mellitus. The main clinical manifestations of DPN include pain, numbness, paraesthesia, and weakness of the lower limbs which often leads to diabetic foot ulceration, eventually resulting in amputation. Based on Traditional Chinese Medicine theory, moxibustion has a great effect on treating and preventing DPN. However, randomized clinical trials done to evaluate the efficacy of this treatment are still lacking. Hence, this study is carried out to evaluate the effectiveness and safety of moxibustion therapy on diabetic peripheral neuropathy.
This study will be a pilot, interventional, randomized, 2-armed, parallel, singled-masked, controlled trial. A total of 40 diabetes mellitus patients with peripheral neuropathy will be recruited and assigned randomly into 2 groups (moxibustion group and waiting group) at a 1:1 ratio. This trial consists of an 8-week intervention period and a 4-week follow-up period. During the intervention period, the moxibustion group will take 3 moxibustion sessions per week, whereas no intervention will be done on the waiting group to act as the control group. The outcome will be assessed by an outcome assessor who is unaware of the group assignment. The primary outcome will be pain assessment measured with algometry, Leeds Assessment of Neuropathic Symptoms and Signs pain scale, visual analogue scale, and neuropathy pain scale. The secondary outcome will be an evaluation of functional performance capacity with 6 minutes walking test, evaluation of the Foot and Ankle Ability Measure, and serum HbA1c and albumin levels.
We hope that this trial will provide valuable insights on the efficacy of moxibustion in the management of diabetic peripheral neuropathy.
ClinicalTrials.gov Registry No.: NCT04894461 (URL: https://clinicaltrials.gov/ct2/show/NCT04894461?term=NCT04894461&draw=2&rank=1) Registered on May 20, 2021.
糖尿病周围神经病变（DPN）是糖尿病最常见的并发症之一。DPN 的主要临床表现包括疼痛、麻木、感觉异常和下肢无力，这些常导致糖尿病足溃疡，最终导致截肢。根据中医理论，艾灸对治疗和预防 DPN 有很好的效果。然而，目前仍缺乏评估这种治疗方法疗效的随机临床试验。因此，本研究旨在评估艾灸疗法治疗糖尿病周围神经病变的有效性和安全性。
这是一项前瞻性、干预性、随机、2 臂、平行、单盲、对照试验。共招募 40 例糖尿病周围神经病变患者，按 1:1 比例随机分为艾灸组和等待组。本试验包括 8 周的干预期和 4 周的随访期。干预期间，艾灸组每周接受 3 次艾灸，而等待组不进行干预作为对照组。结局评估由不知分组情况的结局评估者进行。主要结局指标为压痛评估（压痛计、利兹周围神经病变症状和体征疼痛量表、视觉模拟评分和神经病变疼痛量表）。次要结局指标为 6 分钟步行试验评估的功能表现能力、足踝能力量表评估、血清 HbA1c 和白蛋白水平。
我们希望本试验能为艾灸治疗糖尿病周围神经病变的疗效提供有价值的见解。
ClinicalTrials.gov 注册号：NCT04894461（网址：https://clinicaltrials.gov/ct2/show/NCT04894461?term=NCT04894461&draw=2&rank=1），注册于 2021 年 5 月 20 日。
