Clinical trial NCT05863793: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetic Peripheral Neuropathy
Acupuncture Treatment
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Peroneal Motor Nerve Conduction Velocity
timeFrame: 12 week
Secondary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: 12 week
measure: Fasting plasma glucose (FPG)
timeFrame: 12 week
measure: 2-h postprandial blood glucose (2hPG)
timeFrame: 12 week
measure: Michigan Neuropathy Screening Instrument (MNSI) score
timeFrame: 12 week
measure: Quality of life (QoL)
timeFrame: 12 week
measure: Sural Sensory Nerve Conduction Velocity
timeFrame: 12 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: LongHua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jian Pei
role: STUDY_DIRECTOR
References: