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| Name | Class |
|---|---|
| The Third Affiliated hospital of Zhejiang Chinese Medical University | OTHER |
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Diabetic peripheral neuropathy (DPN) is a common and disabling complication of diabetes. Many patients experience pain, numbness, and impaired quality of life, while currently available treatments may have limited benefit or cause adverse effects. Electroacupuncture (EA) may provide a safe, non-pharmacological treatment option, but further clinical evidence is needed.
The purpose of this study is to evaluate the efficacy and potential mechanisms of low-frequency (2 Hz) electroacupuncture in patients with DPN. In this prospective, randomized, sham-controlled trial, participants will be assigned to either a verum 2 Hz EA group or a sham EA group. The study will assess nerve conduction velocity, pain intensity, serum neurotrophic factors and inflammatory cytokines, and quality of life.
This study is intended to provide clinical evidence on the use of low-frequency EA for DPN and to examine whether its effects are related to neurotrophic and inflammatory pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EA | Experimental | The primary acupoints, included GB34, ST36, ST39 GB39, SP9, SP6,ST41, LR3, and GB41. Supplementary acupoints were added based on clinical presentation: BL60, ST44, and EX-LE10 for significant lower limb pain; and LI11，LI10) SJ5,LI4, and EX-UE9 for concomitant upper limb pain. Disposable sterile acupuncture needles (Hwato brand) in sizes of 0.18 mm × 25 mm and 0.25 mm × 40 mm were used. Following skin disinfection with 75% alcohol swabs, needles were inserted at selected acupoints to elicit a deqi sensation, characterized by local soreness, numbness, or distension reported by the participant. |
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| Sham EA | Sham Comparator | In the sham EA group, two non-acupoint locations on each lower limb were selected. Superficial insertion to a depth of approximately 1-2 mm was performed at these sites using Hwato brand disposable sterile acupuncture needles (0.18 mm × 25 mm). A Hwato SDZ-IIB electronic acupuncture stimulator with deliberately impaired connecting leads was attached to the needles at the sham sites. After the device was turned on and the frequency and intensity parameters were visibly set on the display screen, participants underwent a 30-minute needle retention period. Although the stimulator screen remained active, no actual electrical current was delivered to the needles throughout the session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EA | Other | Disposable sterile acupuncture needles (Hwato brand) in sizes of 0.18 mm × 25 mm and 0.25 mm × 40 mm were used. Following skin disinfection with 75% alcohol swabs, needles were inserted at selected acupoints to elicit a deqi sensation, characterized by local soreness, numbness, or distension reported by the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower limb nerve conduction velocity | Lower limb nerve conduction velocity (NCV) will be measured at baseline and at the end of the 6-week intervention. Assessments will include motor NCV and sensory NCV of the bilateral common peroneal nerves and tibial nerves. | Baseline (week 0) and week 6 (±3 days) |
| Overall clinical response rate | Overall clinical response rate will be assessed at the end of the 6-week treatment period. Treatment efficacy will be categorized into three levels: marked effective, effective, and ineffective. Marked effective will be defined as significant subjective symptom relief accompanied by an increase in nerve conduction velocity (NCV) of ≥5 m/s on electromyography, or recovery to near-normal levels. Effective will be defined as subjective clinical improvement with an NCV increase of <5 m/s. Ineffective will be defined as no significant improvement in clinical symptoms, tendon reflexes, sensory perception, or NCV. The overall clinical response rate will be calculated as (number of marked effective cases + number of effective cases) / total number of participants × 100%. | At the end of week 6 (±3 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale score | The Visual Analog Scale (VAS) will be used to assess pain, numbness, and burning sensations. Scores range from 0 to 10, with higher scores indicating more severe symptoms. | At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days) |
| Toronto Clinical Scoring System score |
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Inclusion Criteria:
- 1.Aged 18-70 years, with no restriction on disease duration or sex. 2.Met the diagnostic criteria for DPN, evidenced by: decreased NCV on lower-limb electroneurography, and/or persistent pain and/or sensory abnormalities in the limbs (at least in both lower limbs), with diminished ankle reflex (unilateral or bilateral) and reduced vibration sense, and a Toronto Clinical Scoring System (TCSS) score ≥ 6.
3.Able to communicate effectively. 4.No severe systemic medical conditions (e.g., cardiac, cerebral, hepatic, or renal disorders), severe psychiatric illnesses, or cognitive impairment.
5.Mentally competent, voluntarily agree to participate in the study, and provide written informed consent.
Exclusion Criteria:
1.Peripheral neuropathy due to other etiologies (e.g., hypothyroidism, alcohol, medications, hereditary causes), presence of limb ulcers or gangrene, or a history of skin ulceration or poorly healing lesions.
2.Severe comorbid conditions, including renal, cardiovascular, cerebrovascular, pulmonary, or hepatic diseases, infectious diseases, malignancies, or severe psychiatric disorders.
3.History of knee/hip replacement surgery or lower limb fracture within the past 3 months, or any other condition that could interfere with the assessment of neuropathy.
4.Received acupuncture or moxibustion treatment specifically for DPN within the past 3 months.
5.Concurrent participation in another interventional clinical trial. 6.Women who are planning pregnancy, are pregnant, or are lactating. 7.Unwillingness to be randomized to either the waitlist (WL) or EA group. 8.Chronic abuse of opioids, analgesics, illicit drugs, or alcohol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Luo | Contact | +8615083521014 | 921941696@qq.com |
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| Sham EA | Other | Superficial insertion to a depth of approximately 1-2 mm was performed at these sites using Hwato brand disposable sterile acupuncture needles (0.18 mm × 25 mm). A Hwato SDZ-IIB electronic acupuncture stimulator with deliberately impaired connecting leads was attached to the needles at the sham sites. After the device was turned on and the frequency and intensity parameters were visibly set on the display screen, participants underwent a 30-minute needle retention period. Although the stimulator screen remained active, no actual electrical current was delivered to the needles throughout the session. |
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The Toronto Clinical Scoring System (TCSS) will be used to assess the severity of diabetic peripheral neuropathy. The TCSS is a 19-point composite scale consisting of symptom, reflex, and sensory test components. Higher scores indicate greater severity of neuropathy. |
| At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days) |
| Diabetes Quality of Life scale score | The Diabetes Quality of Life (DQoL) scale will be used to assess quality of life. In the version used in this study, the total score ranges from 27 to 135, with lower scores indicating better quality of life. | At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days) |
| Serum nerve growth factor concentration | Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum nerve growth factor (NGF) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). | At baseline (week 0), week 3 (±3 days), week 6 (±3 days) |
| Serum brain-derived neurotrophic factor concentration | Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum brain-derived neurotrophic factor (BDNF) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). | At baseline (week 0), week 3 (±3 days), week 6 (±3 days) |
| Serum tumor necrosis factor-alpha concentration | Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum tumor necrosis factor-alpha (TNF-alpha) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). | At baseline (week 0), week 3 (±3 days), week 6 (±3 days) |
| Serum interleukin-6 concentration | Fasting peripheral venous blood samples will be collected in the morning at each assessment time point. Serum interleukin-6 (IL-6) concentration will be measured using enzyme-linked immunosorbent assay (ELISA). | At baseline (week 0), week 3 (±3 days), week 6 (±3 days) |
| Hemoglobin A1c | Hemoglobin A1c (HbA1c) will be measured to assess glycemic control. | At baseline (week 0), week 6 (±3 days), |
| Fasting plasma glucose | Fasting plasma glucose (FPG) will be measured to assess glycemic control. | At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days) |
| 2-hour postprandial glucose | Two-hour postprandial glucose (2hPG) will be measured to assess glycemic control. | At baseline (week 0), week 3 (±3 days), week 6 (±3 days), and week 10 (±3 days) |