Effect of acupuncture using the HeSantong method on diabetic peripheral neuropathy
| ISRCTN | ISRCTN96103936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96103936 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/12/2013
- Registration date
- 17/02/2014
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Mei Shu Guan Hou Jie
Dong Cheng District
Beijing
100010
China
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of acupuncture using the HeSantong method on diabetic peripheral neuropathy: a randomised controlled trial |
| Study objectives | 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(s) | Ethics Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 29/11/2013, ref. 2013BL-085-01 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2013 |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2013 |
| Date of final enrolment | 31/07/2015 |
Locations
Countries of recruitment
- China
Study participating centre
100010
China
Sponsor information
Hospital/treatment centre
c/o Jinghong YI
23 Mei Shu Guan Hou Jie
Dong Cheng District
Beijing
100010
China
"ROR" |
https://ror.org/057vq6e26 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/09/2020: No publications found.
