- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05863793
Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
May 17, 2023 updated by: Shanghai University of Traditional Chinese Medicine
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jian Pei, Ph.D
- Phone Number: 3534 86-021-64385700
- Email: longhuaacup@aliyun.com
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Longhua Hospital Shanghai University of Traditional Chinese Medicine
-
Contact:
- Jian Pei, Doctor
- Phone Number: 3534 00862164385700
- Email: longhuaacup@aliyun.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual Acupuncture Group
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.
|
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.
|
Sham Comparator: Sham Acupuncture
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peroneal Motor Nerve Conduction Velocity
Time Frame: 12 week
|
Measurement by electromyography
|
12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycated hemoglobin (HbA1c)
Time Frame: 12 week
|
Observe the changes during the study period
|
12 week
|
Fasting plasma glucose (FPG)
Time Frame: 12 week
|
Observe the changes during the study period
|
12 week
|
2-h postprandial blood glucose (2hPG)
Time Frame: 12 week
|
Observe the changes during the study period
|
12 week
|
Michigan Neuropathy Screening Instrument (MNSI) score
Time Frame: 12 week
|
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)
Time Frame: 12 week
|
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
Time Frame: 12 week
|
Measurement by electromyography
|
12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jian Pei, Shanghai University of Traditional Chinese Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Anticipated)
January 1, 2025
Study Completion (Anticipated)
January 1, 2025
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
May 17, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
May 18, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016LCSY028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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