Diabetic Peripheral NeuropathyNCT05863793
Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
A study testing Acupuncture in people with Diabetic Peripheral Neuropathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Jian Pei, Doctor, 00862164385700 ext. 3534, longhuaacup@aliyun.com
About this study
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Diabetic Peripheral Neuropathy, Acupuncture Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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.
Sham AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroneal Motor Nerve Conduction Velocity
Measurement by electromyography
Measured: 12 week
Secondary outcomes (6)
Glycated hemoglobin (HbA1c)
Observe the changes during the study period
Measured: 12 week
Fasting plasma glucose (FPG)
Observe the changes during the study period
Measured: 12 week
2-h postprandial blood glucose (2hPG)
Observe the changes during the study period
Measured: 12 week
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.
Measured: 12 week
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.
Measured: 12 week
Sural Sensory Nerve Conduction Velocity
Measurement by electromyography
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Sep 2021
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Pei, Study director, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863793
- Sponsor's protocol ID
- 2016LCSY028
- Status last verified
- May 2023
- First submitted
- 24 Mar 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05863793
- Acronym / sponsor ID
- 2016LCSY028
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetic Peripheral Neuropathy, Acupuncture Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Acupuncture Group | Experimental | Other: AcupunctureTreatment 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. |
| Sham Acupuncture | Sham comparator | Other: Sham AcupunctureThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Other | Manual Acupuncture Group |
| Sham AcupuncturePatients 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. | Other | Sham Acupuncture |
Primary outcome
Peroneal Motor Nerve Conduction Velocity
Time frame: 12 week
Measurement by electromyography
6 secondary outcomes
Glycated hemoglobin (HbA1c)
Time frame: 12 week
Fasting plasma glucose (FPG)
Time frame: 12 week
2-h postprandial blood glucose (2hPG)
Time frame: 12 week
Michigan Neuropathy Screening Instrument (MNSI) score
Time frame: 12 week
Quality of life (QoL)
Time frame: 12 week
Sural Sensory Nerve Conduction Velocity
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Pei study director
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Diabetic Peripheral Neuropathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Pei, Ph.D (86-021-64385700 ext. 3534, longhuaacup@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peroneal Motor Nerve Conduction Velocity (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.