Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

Study Overview
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Brief Summary
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This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.

Detailed Description
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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.

Official Title
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Efficacy of Moxibustion in Diabetes Peripheral Neuropathy

Conditions
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Peripheral Neuropathy, Diabetic Neuropathies

Intervention / Treatment
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* Device: Moxibustion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxibustion<br>Moxibustion treatment sessions eight weeks from the baseline. | Device: Moxibustion<br>* The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.<br>* Other names: Moxa stick;|
| No Intervention: Waiting<br>A waiting period of eight weeks by moxibustion treatment sessions in the same way with moxibustion group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment measured with Algometry | For determining sensitivity to pain produced by pressure | Measured from Baseline pain at 8 weeks | 
| Pain assessment measured with the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale | 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 | Measured from Baseline pain at 8 weeks | 
| Pain assessment measured with the Visual Analog Scale | 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. | Measured from Baseline pain at 8 weeks | 
| Pain assessment measured with the Neuropathy Pain Scale (NPS) | 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. | Measured from Baseline pain at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of functional performance capacity with 6 minutes walking test | It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. | Measured from Baseline results at 8 weeks | 
| Evaluation of the Foot and Ankle Ability Measure (FAAM). | It is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. | Measured from Baseline results at 8 weeks | 
| Serum HbA1c | It is provides accurate long-term index of average blood glucose level | Measured from Baseline results at 8 weeks | 
| Serum Albumin levels | It is measures the amount of the protein albumin in human blood | Measured from Baseline results at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moxibustion, Peripheral Neuropathy