Plain English Summary
Background and study aims
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes, which may lead to diabetic foot ulcers and foot or limb amputations. It is commonly treated by acupuncture. There are many published cases reports showing that acupuncture works for DPN. More in-depth research is needed and this is the aim of this study (Wentong Method of Hesantong Method based on Hesantong Method developed by Professor He Puren).
Who can participate?
Participants diagnosed with DPN.
What does the study involve?
Participants are randomly allocated to one of two groups: Wentong Method/Hesantong Method group or Shallow acupuncture at sham points group. Participants undergo a number of tests before and after the 8-week treatment.
What are the possible benefits and risks of participating?
Participants may experience infection, hematoma, syncope, discomfort after the acupuncture.
Where is the study run from?
BeiJing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)
When is study starting and how long is it expected to run for?
August 2013 to July 2015.
Who is funding the study?
BeiJing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)
Who is the main contact?
Professor Yi Jinghong
kycyjh@sina.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of acupuncture using the HeSantong method on diabetic peripheral neuropathy: a randomised controlled trial
Acronym
Study hypothesis
1. The Wentong method and HeSantong method are both specific and holistic. This non-drug therapy has tremendous potential and is likely to treat diabetic peripheral neuropathy as expected.
2. Objective and comprehensive evaluating indexes can improve the credibility of acupuncture using the Wentong method and the HeSantong method on diabetic peripheral neuropathy.
Ethics approval
Ethics Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 29/11/2013, ref. 2013BL-085-01
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetic Peripheral Neuropathy
Intervention
Patients are randomised to receive the following treatments:
1. Acupuncture using the Wentong method and the Hesantong method
Main points: Yanglingquan, Zusanli, Taixi, Ashi points
Needling method: Wentong Method and HeSantong method
Treating course: treatment given twice a week for 8 weeks as one course of treatment
2.Shallow acupuncture at sham points
Points: sham meridians and points
Needling method: Shallow acupuncture at sham points
Treating course: treatment given twice a week for8 weeks as one course of treatment
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Traditional Chinese medicine (TCM) syndrome score at baseline, after treatment for 4 and 8 weeks, and after 4 weeks of completing the treatment
2. Nerve electrophysiological examination at baseline and after 8 weeks treatment
Secondary outcome measures
MDNS at baseline, after treatment for 4 and 8 weeks and after 4 weeks of completing the treatment
Overall trial start date
01/08/2013
Overall trial end date
31/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient has diabetic peripheral neuropathy
2. Patient aged 18 to 70 years
3. Michigan diabetic neuropathy score (MDNS) of 7 to 29
4. Fasting blood glucose (FBG) less than or equal to 8.0mmol/L, Postprandial Plasma Glucose (PPG) less than or equal to 11.0 mmol/L
5. Patient providing informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patient suffering from acute complications of diabetes within one month
2. Patients with spinal cord injury, spinal deformity, stroke sequela and neuromuscular disorders or peripheral neuropathy caused by other factors (such as heredity, alcoholism, uremia, infection, malnutrition, drug intoxication and metal intoxication)
3. Patient having epilepsy or mental illness
4. Patient having arteriovenous disease
5. Patient having the following complications: serious primary diseases of other systems, abnormal liver and kidney function, overwhelming infection or advanced tumor
6. Dipsomanias
7. Drug abuse over the past five years or been exposed to chemical poisons
Recruitment start date
01/08/2013
Recruitment end date
31/07/2015
Locations
Countries of recruitment
China
Trial participating centre
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China
Funders
Funder type
Hospital/treatment centre
Funder name
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list