Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim of this trial is to determine the efficacy and safety of manual acupuncture (MA) versus sham acupuncture (SA) for DPN.

Detailed Description
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A total of 118 patients with DPN will be recruited and randomly assigned in a 1:1 ratio to either the MA group or SA group. All patients will receive 24 sessions over 12 weeks. Participants will complete the trial by visiting the research center at month 6 for a follow-up assessment. The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline. Secondary outcomes include peroneal motor nerve action potential amplitude (peroneal MNAP) and latent period (peroneal MNLP), sural sensory nerve conduction velocity (sural SNCV), action potential amplitude (sural SNAP) and latent period (sural SNLP), fasting plasma glucose (FPG), 2-h postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc) at week 12 compared with baseline, Michigan Neuropathy Screening Instrument (MNSI) score and Diabetes Specific Quality of Life scale (DSQL) at week 12 and month 6 compared with baseline. Safety will be assessed during the whole trial. Masking effectiveness will be assessed by patients.

Official Title
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Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Aged 18-75 years (either sex) Patients who meet diagnosis of DPN defined by ADA in 2005：a. DPN is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes, after the exclusion of other causes. b. NP is defined as altered sensitivity to pressure and (1) altered sensitivity to pain or (2) altered sensitivity to vibration or (3) achilles reflex. Symmetric and predominantly sensory, starting from the lower limbs distally and gradually spreading proximally in a glove-and-stocking distribution. Ability to understand study procedures and willingness to comply with them for the entire period of study. Written informed consent Exclusion Criteria: PN caused by conditions other than diabetes (e.g.,alcohol abuse, chemotherapy, hereditary causes, chronic inflammatory, or idiopathic PN) Psychiatric illnesses other than mild depression. Severe or unstable cardiovascular, liver, kidney, respiratory, or hematological disorders. Received acupuncture treatment in the last 3 months. Pregnant or lactating women. Research unit personnel directly related to the study and their immediate family members. Incapable of giving informed consent or following the study instructions due to language disturbances, serious cognitive deficits, or lack of time. Currently participating in other clinical trials.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Acupuncture Group<br>Treatment will be performed by licensed acupuncturists who have at least 5 years of experience in acupuncture. All the acupuncturists will be trained how to locate acupoints, puncture, and manipulate needles before trials. | Other: Acupuncture<br>* The obligatory acupoints include Zhongwan (CV12), bilateral Weiwanxiashu (EX-B3), bilateral Ganshu (BL18), bilateral Pishu (BL20), bilateral Shenshu (BL23), bilateral Zusanli (ST36), bilateral Yanglingquan (GB34), bilateral Sanyinjiao (SP6), bilateral Taixi (KI3), and Bafeng (EX-LE10). Additional acupoints Baxie (EX-UE9) will be added when patients' symptoms appear not only in the lower limbs but also in the upper limbs. After skin disinfection, disposable, stainless steel acupuncture needles will be inserted into the skin of acupoint (approximately 10-20 mm depth), and then manipulations of twirling, lifting, and thrusting will be performed on all needles for at least 10 s to reach De qi (a compositional sensation including soreness, numbness, distention, and heaviness), which is believed to be an essential component for acupuncture efficacy. Needles will be retained in these acupoints for 20 min.<br>|
| Sham Comparator: Sham Acupuncture<br>The procedure and duration of treatment in the sham acupuncture group will be identical in the MA group except the needles are blunt tip and there will be no skin penetration and needle manipulation for De qi. | Other: Sham Acupuncture<br>* Patients in the SA group will receive sham acupuncture. The procedure and duration of treatment in the SA group will be identical in the MA group except the needles are blunt tip and there will be no skin penetration and needle manipulation for De qi.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroneal Motor Nerve Conduction Velocity | Measurement by electromyography | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (HbA1c) | Observe the changes during the study period | 12 week | 
| Fasting plasma glucose (FPG) | Observe the changes during the study period | 12 week | 
| 2-h postprandial blood glucose (2hPG) | Observe the changes during the study period | 12 week | 
| Michigan Neuropathy Screening Instrument (MNSI) score | The MNSI is a clinical and semi-quantitative evaluation of neuropathy that includes medical history and physical assessment. Medical history will be completed by patients with scores ranging between 0 and 13. Physical assessment will be completed by health professionals with five indicators and the aggregate score ranging between 0 and 10: foot appearance (0 and 1 for normal and abnormal, respectively), ulceration (0 and 1 for normal and abnormal, respectively), ankle reflex (0, 0.5, and 1 for normal, reenforced, and absent, respectively), vibration test (0, 0.5, and 1 for normal, weakened, and absent, respectively), and monofilament examination (0, 0.5, and 1 for normal, weakened, and absent, respectively) of feet on both sides. | 12 week | 
| Quality of life (QoL) | Disease-specific QoL will be assessed at baseline and at week 12, month 6 after randomization using Diabetes Specific Quality of Life scale (DSQL). The scale consists of four domains: interference (12 items), psychology (8 items), social relations (4 items), and treatment (3 items). Each item is measured with a 5-point Likert scale ranging from not at all to extremely. Higher scores indicate worse QoL. | 12 week | 
| Sural Sensory Nerve Conduction Velocity | Measurement by electromyography | 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Peripheral Neuropathy, Acupuncture Treatment