Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy

NCT05863793 | Unknown DMC

• 1 other identifier: 2016LCSY028
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Acupuncture Treatment

Outcome Measures

Primary Outcomes (1)

• Peroneal Motor Nerve Conduction Velocity

  Measurement by electromyography

  12 week

Secondary Outcomes (6)

• Glycated hemoglobin (HbA1c)

  12 week

• Fasting plasma glucose (FPG)

  12 week

• 2-h postprandial blood glucose (2hPG)

  12 week

• Michigan Neuropathy Screening Instrument (MNSI) score

  12 week

• Quality of life (QoL)

  12 week

Study Arms (2)

Manual Acupuncture Group

EXPERIMENTAL

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

Sham Acupuncture

SHAM COMPARATOR

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

Interventions

Acupuncture OTHER

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.

Manual Acupuncture Group

Sham Acupuncture OTHER

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18-75 years (either sex)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

LongHua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jian Pei

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Jian Pei, Ph.D

CONTACT

86-021-64385700; longhuaacup@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 18, 2023
• Study Start: September 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)