Back to resultsClinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Diabetic Peripheral Neuropathy, Acupuncture Treatment
Eligibility Criteria
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.
Sites / Locations
- LongHua Hospital Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Manual Acupuncture Group
Sham Acupuncture
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Peroneal Motor Nerve Conduction Velocity
Measurement by electromyography
Secondary Outcome Measures
Glycated hemoglobin (HbA1c)
Observe the changes during the study period
Fasting plasma glucose (FPG)
Observe the changes during the study period
2-h postprandial blood glucose (2hPG)
Observe the changes during the study period
Michigan Neuropathy Screening Instrument (MNSI) score
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.
Quality of life (QoL)
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.
Sural Sensory Nerve Conduction Velocity
Measurement by electromyography
Full Information
NCT ID
NCT05863793
First Posted
March 24, 2023
Last Updated
May 17, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05863793
Brief Title
Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
Official Title
Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Diabetic Peripheral Neuropathy, Acupuncture Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual Acupuncture Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peroneal Motor Nerve Conduction Velocity
Description
Measurement by electromyography
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c)
Description
Observe the changes during the study period
Time Frame
12 week
Title
Fasting plasma glucose (FPG)
Description
Observe the changes during the study period
Time Frame
12 week
Title
2-h postprandial blood glucose (2hPG)
Description
Observe the changes during the study period
Time Frame
12 week
Title
Michigan Neuropathy Screening Instrument (MNSI) score
Description
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.
Time Frame
12 week
Title
Quality of life (QoL)
Description
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.
Time Frame
12 week
Title
Sural Sensory Nerve Conduction Velocity
Description
Measurement by electromyography
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Pei, Ph.D
Phone
86-021-64385700
Ext
3534
Email
longhuaacup@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Pei
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
LongHua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Pei, Doctor
Phone
00862164385700
Ext
3534
Email
longhuaacup@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
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