Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
NCT ID: NCT05863793
Last Updated: 2023-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
118 participants
INTERVENTIONAL
2021-09-01
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Acupuncture
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 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.
Sham Acupuncture
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.
Interventions
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Acupuncture
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 Acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Jian Pei
Role: STUDY_DIRECTOR
Shanghai University of Traditional Chinese Medicine
Locations
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LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016LCSY028
Identifier Type: -
Identifier Source: org_study_id
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