Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

Not Applicable

Not yet recruiting

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Procedure: Basal therapy+EA; Other: Basal therapy

• Registration Number: NCT06054087
• Lead Sponsor: Zhejiang Chinese Medical University

Brief Summary

Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus, which mainly manifests symmetric pain, numbness, ankylosis, or with abdominal distension, abnormal sweating, and accompanied by glove-sock-like hyperalgesia or loss of sensation as the main symptom, which seriously affects the quality of life of patients. Although drug treatment has some effect, from the overall long-term perspective, long-term medication is easy to produce drug dependence, and often easy to cause ataxia, blurred vision, constipation, diplopia, nausea and other adverse drug reactions. Electroacupuncture treatment for DPN has certain advantages, with clear efficacy and no toxic side effects, and is being increasingly recognised by the public and professionals. The study is designed to observe the therapeutic effect and safety of electroacupuncture (EA) in the treatment of DPN.

Detailed Description

A total of 104 subjects with DPN who meet the inclusion criteria will be included in the study. Subjects will be classified as mild, moderate and severe in terms of severity by using the toronto clinical scoring system（TCSS）, and subsequently randomised into the EA group and the waiting list group by using a central randomisation system. The indexes of main outcome evaluation are: sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (MNCV) of the tibial and peroneal nerves of the lower extremities. The indexes of secondary outcome evaluation are: 1) Overall clinical effectiveness rate; 2) TCSS score; 3) Chinese medicine symptom score; 4) patient's global impression of change (PGIC); 5) regional temperature test; and 6) laboratory tests (glycosylated haemoglobin, fasting blood glucose, and postprandial 2h blood glucose). This study will evaluate the effectiveness of EA in treating DPN and assess the difference in the efficacy of EA in treating patients with DPN of different severity, as well as explore the feasibility of regional temperature as an indicator for assessing the efficacy of DPN. And based on the results, a standardised, effective and convenient EA treatment protocol will be established for promotion.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-26
• Last Update Posted: 2023-09-26
• Study Start: 2023-10
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. 18 years ≤ age ≤ 85 years, disease duration is not limited, gender is not limited;
2. Lower limb neuromuscular electromyography showing reduced conduction velocity, and/or persistent pain and/or sensory abnormalities in the extremities (at least in both lower limbs), bilateral or unilateral weakened ankle reflexes, reduced vibration sensation, and a TCSS score ≥ 6;
3. Have normal communication skills;
4. No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment;
5. those who voluntarily obeyed the study protocol and signed the informed consent form.

Exclusion Criteria

1. Persons with peripheral neuropathy, ulcers and gangrene of the limbs caused by a variety of other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or persons with a history of skin ulcers or lesions that do not heal easily;
2. Presence of serious diseases, including renal disease, cardiovascular disease, pulmonary disease, liver disease or infectious disease, or malignant tumour and serious mental illness, etc;
3. Prior history of knee/hip replacement surgery or lower limb fracture within the past 3 months, and other conditions that may affect the assessment of neuropathy
4. Patients who have received acupuncture or moxibustion treatment for DPN within the past 3 months;
5. Volunteers who are participating in other interventional clinical trials;
6. Women who are preparing for pregnancy, pregnant or breastfeeding;
7. Those who have scars or hyperpigmentation of the skin at the testing site, which affects the accuracy of the test;
8. Unwilling to be randomly assigned to the waiting treatment group or electroacupuncture treatment group;
9. Chronic abuse of opioids, analgesics, illicit drugs or alcohol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EA group	Basal therapy+EA	Subjects in this group received electroacupuncture along with the basic treatment at a frequency of 2 treatments per week for 6 weeks for a total of 12 interventions. The follow-up period is one month.
Waiting list group	Basal therapy	The subjects in this group will receive only basal treatment with no additional therapies during the study period. After the end of the study period, patients were given 12 acupuncture treatments

Primary Outcome Measures

Name	Time	Method
Sensory conduction velocity of superficial peroneal nerve	Baseline, 6 weeks
Motor conduction velocity of tibial nerve	Baseline, 6 weeks
Motor conduction velocity of Peroneal nerve	Baseline, 6 weeks
Sensory conduction velocity of sural nerve	Baseline, 6 weeks

Secondary Outcome Measures

Name	Time	Method
Regional temperatures of instep	Baseline, 6 weeks	Before and after treatment, the temperature of the instep will be measured using an infrared thermal imager
Patient Global Impression of Change(PGIC)	Baseline, 3 weeks, 6 weeks, 10 weeks	PGIC is scored on a 7-point scale, with higher scores representing poorer efficacy. a score of 1 indicates that the subject perceives a great improvement in efficacy, 4 is no change before and after acupuncture treatment, and 7 is much worse after treatment.
Toronto clinical scoring system（TCSS）	Baseline, 3 weeks, 6 weeks, 10 weeks	The scale is an assessment of foot sensation and has a total score of 19, divided into three sections: symptom score of 6, reflex score of 8 and sensory score of 5. Symptom score: 0 = absent, 1 = present; reflex score: 0 = normal, 1 = diminished, 2 = absent; sensory score: 0 = normal, 1 = abnormal.
TCM syndromes efficacy score scale	Baseline, 3 weeks, 6 weeks, 10 weeks	TCM syndromes efficacy score is 42, ranging from 0 (least severe) to 42 (most severe).
Regional temperatures of palm	Baseline, 6 weeks	Before and after treatment, the regional temperature of the palm will be measured using an infrared thermal imager.
Glycated haemoglobin (HbA1c）	Baseline, 6 weeks
Fasting blood glucose (FPG)	Baseline, 3 weeks, 6 weeks, 10 weeks
2-hour postprandial blood glucose (2hPG)	Baseline, 3 weeks, 6 weeks, 10 weeks
Overall clinical effectiveness rate	3 weeks, 6 weeks, 10 weeks	Total effective rate = \[(number of cured cases + number of effective cases)/total number of cases \] × 100%.
Regional temperatures of sole of the foot	Baseline, 6 weeks	Before and after treatment, the temperature of the sole of the foot will be measured using an infrared thermal imager
Regional temperatures of back of the hand	Baseline, 6 weeks	Before and after treatment, the regional temperature of the back of the hand will be measured using an infrared thermal imager.

Trial Locations

Locations (1)

the Third affiliated hospital of Zhejiang Chinese Medical university; 🇨🇳 Hangzhou, Zhejiang, China