Efficacy of Moxibustion in Diabetes Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Pain assessment measured with Algometry
研究概览
简要总结
This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.
详细描述
Background: The purpose of this study is to investigate the clinical effects of moxibustion for treating diabetes peripheral neuropathy.
Hypothesis
Subjects who have participated in the moxibustion treatment will have greater improvement in people with diabetes with signs and symptoms of peripheral neuropathy than the control group after 8 weeks.
Design and subjects: A pilot randomized controlled trial. Subjects with diabetes peripheral neuropathy will be recruited from the community. 30 subjects will be randomized to moxibustion groups and control groups in a 1:1 ratio.
Interventions: Subjects in the moxibustion group will receive three times per week for 12 weeks; control groups will be allocated to the waitlist will receive no moxibustion treatments throughout the 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria.
- •Proven peripheral neuropathy.
- •Written consent with documentation that all participants received relevant information about this study is given to the patient.
- •The participants must be willing and able to meet the planned visit and meet the planned schedule, including participation in the experimental investigations.
排除标准
- •Health professionals' assessment makes the patient have medical or surgical diseases unsuitable to participate in the study.
- •Pregnancy or breastfeeding for female patients.
- •Competitive conditions that can cause peripheral neuropathy.
- •Participants involved in the planning or execution of the study.
结局指标
主要结局
Pain assessment measured with Algometry
时间窗: Measured from Baseline pain at 8 weeks
For determining sensitivity to pain produced by pressure
Pain assessment measured with the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
时间窗: Measured from Baseline pain at 8 weeks
The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale is based on analysis of sensory description and bedside examination of sensory dysfunction, and provides immediate information in clinical settings. The possible scores range from 0 to 24, with a score of 12 or greater considered to be suggestive of neuropathic pain
Pain assessment measured with the Visual Analog Scale
时间窗: Measured from Baseline pain at 8 weeks
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Pain assessment measured with the Neuropathy Pain Scale (NPS)
时间窗: Measured from Baseline pain at 8 weeks
Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable. The NPS is only for use in patients who have already been diagnosed with neuropathic pain.
次要结局
- Evaluation of functional performance capacity with 6 minutes walking test(Measured from Baseline results at 8 weeks)
- Evaluation of the Foot and Ankle Ability Measure (FAAM).(Measured from Baseline results at 8 weeks)
- Serum HbA1c(Measured from Baseline results at 8 weeks)
- Serum Albumin levels(Measured from Baseline results at 8 weeks)
研究者
Kim Yun Jin
Associate Professor
Xiamen University Malaysia