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Laser Acupuncture on Diabetes-induced Peripheral Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
laser acupuncture
sham laser acupuncture
Sponsored by
Taiwan Municipal An-Nan Hospital-China Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring diabetic peripheral neuropathy, laser acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: female or male patients (aged over 18 years) with diabetes mellitus type II. patients have symptoms (numbness, tingling, burning, stabbing, shooting pain, etc.) and signs (symmetric decreased distal sensation, or decreased or absent ankle reflexes) of diabetic neuropathy. presence of abnormal nerve conduction study, or presence of neuropathy is likely tested by Semmes-Weinstein 10-g monofilament, or decreased vibration sensation tested by 128Hz vibration tuning fork patients who have completed titration of pain medication or stopped accepting physical therapy against DPN; must provide written informed consent. Exclusion Criteria: severe DPN with muscular weakness of the proximal leg muscles; neuropathy due to other reasons (such as HIVD, malignancy, severe renal disease, hepatitis, thyroid disease, vitamine B12 deficiency, virus infection (such as: human immunodeficiency virus infection, etc), syphilis, alcohol, neurotoxic drug use, inflammatory disease (such as chronic inflammatory demyelinating polyneuropathy), heavy metal intoxication, hereditary disease, etc) severe peripheral artery disease in Fontaine stage IV(Focal tissue necrosis, ulceration or gangrene); traumatic lesions of the nerves or vessels in the lower extremities; opioid use before inclusion in the study; regular use of cannabis or cannabinoids; severe mental illness; severe impairment of cognitive function; pregnancy or lactation obesity (BMI>35 kg/m2)

Sites / Locations

  • Tainan Municipal An Nan Hospital-China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

laser acupuncture group

sham laser acupuncture group

Arm Description

This study will use the Handylaser Trion laser manufactured by RJ Laser, Germany. It will be used for 40 seconds to deliver 6 J of energy as a pulsed wave (Noiger E) at each acupoint near palms or plantar, such as bilateral LI 4, PC6, KI 3, LR 3. For distal points in the four limbs, the laser will be used for 40 seconds at each acupoint to deliver 6J of energy as a pulsed wave (Noiger B), such as bilateral LI11, GB 34, ST 36, SP 6.

This study will use the sham Handylaser Trion laser manufactured by RJ Laser, without any laser beam delivering. The acupoints of the sham-laser acupuncture are the same as those of the laser acupuncture group.

Outcomes

Primary Outcome Measures

the Brief Pain Inventory-Short Form
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form(Ger, et al. 1999) (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.
the Brief Pain Inventory-Short Form
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form(Ger, et al. 1999) (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.
the Brief Pain Inventory-Short Form
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form(Ger, et al. 1999) (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.

Secondary Outcome Measures

The Michigan Neuropathy Screening Instrument (MNSI)
The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument, the history questionnaire, consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical assessment (completed by health professionals) involving:1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection; 2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe; 3) grading of ankle reflexes and 4) monofilament testing. Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation.
The Michigan Neuropathy Screening Instrument (MNSI)
The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument, the history questionnaire, consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical assessment (completed by health professionals) involving:1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection; 2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe; 3) grading of ankle reflexes and 4) monofilament testing. Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation
Semmes-Weinstein Monofilament(SWM)
SWM is a clinically easy-to-administer, quantifiable, and reliable tool for evaluating protective sensation loss(Kamei, et al. 2005). Measurements were performed using a set of 20 von Frey monofilaments (Semmes-Weinstein von Frey Aesthesiometer, Stoelting Co., Wood Dale, IL, USA), with evaluator size/target forces ranging from 1.65/0.008 g to 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Measurement sites included the sole, tip of the big toe, palm, and tip of the middle finger. All tests were performed by an independent assessor who was blinded to the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer.
Semmes-Weinstein Monofilament(SWM)
SWM is a clinically easy-to-administer, quantifiable, and reliable tool for evaluating protective sensation loss(Kamei, et al. 2005). Measurements were performed using a set of 20 von Frey monofilaments (Semmes-Weinstein von Frey Aesthesiometer, Stoelting Co., Wood Dale, IL, USA), with evaluator size/target forces ranging from 1.65/0.008 g to 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Measurement sites included the sole, tip of the big toe, palm, and tip of the middle finger. All tests were performed by an independent assessor who was blinded to the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer.
Nerve conduction velocity (NCV)
NCV will be performed on both lower extremities at baseline and the week 8 (the end of treatment). Peroneal motor nerve conduction velocity (MNCV), sural sensory nerve conduction velocity (SNCV), and tibial motor nerve conduction velocity (MNCV) will be measured.
Nerve conduction velocity (NCV)
NCV will be performed on both lower extremities at baseline and the week 8 (the end of treatment). Peroneal motor nerve conduction velocity (MNCV), sural sensory nerve conduction velocity (SNCV), and tibial motor nerve conduction velocity (MNCV) will be measured.

Full Information

First Posted
June 15, 2023
Last Updated
June 25, 2023
Sponsor
Taiwan Municipal An-Nan Hospital-China Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05921019
Brief Title
Laser Acupuncture on Diabetes-induced Peripheral Neuropathy
Official Title
The Efficacy of Laser Acupuncture on the Diabetes-induced Peripheral Neuropathy: Basic and Clinical Research
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taiwan Municipal An-Nan Hospital-China Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Diabetic peripheral neuropathy (DPN) is one of the microvascular complications of diabetes mellitus. This can lead to painful and costly clinical sequelae such as foot ulcers, amputation, and neuropathic pain. There are several novel diagnostic methods available for complementary to clinical assessment and may help in the early detection of DPN. However, treatments for DPN and painful DPN are limited. We will conduct a pilot, single-center, randomized controlled trial in patients with DPN to verify the effect of the laser acupuncture on DPN. With designed inclusion and exclusion criteria, 30 eligible participants will be randomized with 1:1 allocation ratio to the following two groups:(1) the laser acupuncture group (N=15), (2) the sham laser acupuncture group (N=15). Each participant will receive 24 interventions within 8 weeks, three times per week. Participants follow the laser acupuncture protocol in our study. All participants will be clinically assessed by (1) Michigan Neuropathy Screening Instrument (MNSI), (2) questionnaires (BPI(SF)-DPN) for diabetic neuropathic pain assessment, and (3) nerve conduction test. This research project will validate our novel preliminary findings demonstrating neuroprotective effects of laser acupuncture treatment. Importantly, our data are expected to elucidate how laser acupuncture induces neuroprotection in the clinical setting and provide a scientific base for developing new approaches in the treatment of DPN.
Detailed Description
This prospective, randomized, single-center, parallel-group study will be cooperatively conducted in the neurology and traditional Chinese medicine department of Tainan Municipal An-Nan Hospital, China Medical University in Tainan, Taiwan. Study approval will be applied from the TMANH Research Ethics Committee. After screening eligibility and completing baseline assessments, we obtained informed consent from all patients before enrollment. Participants were randomized to either the laser acupuncture, the sham laser acupuncture group using a block randomization method with allocation ratio of 1:1(Figure 7). Before study commencement, the statistician created a randomization sequence using IBM® SPSS® Statistics and contained it in sealed envelopes. The balanced sample size was ensured by dividing the participants into blocks of two. All eligible participants and assessors were unaware of the assignment order. Both the physician and participants will be unaware of the group allocation. Participants were allowed to withdraw from the study at any time. • Patient eligibility We included the patients with the following inclusion criteria(Dietzel, et al. 2021): female or male patients (aged over 18 years) with diabetes mellitus type II. patients have symptoms (numbness, tingling, burning, stabbing, shooting pain, etc.) and signs (symmetric decreased distal sensation, or decreased or absent ankle reflexes) of diabetic neuropathy. presence of abnormal nerve conduction study, or presence of neuropathy is likely tested by Semmes-Weinstein 10-g monofilament, or decreased vibration sensation tested by 128Hz vibration tuning fork patients who have completed titration of pain medication or stopped accepting physical therapy against DPN; must provide written informed consent. The main exclusion criteria for the patients are as follows: severe DPN with muscular weakness of the proximal leg muscles; neuropathy due to other reasons (such as HIVD, malignancy, severe renal disease, hepatitis, thyroid disease, vitamine B12 deficiency, virus infection (such as: human immunodeficiency virus infection, etc), syphilis, alcohol, neurotoxic drug use, inflammatory disease (such as chronic inflammatory demyelinating polyneuropathy), heavy metal intoxication, hereditary disease, etc) severe peripheral artery disease in Fontaine stage IV(Focal tissue necrosis, ulceration or gangrene); traumatic lesions of the nerves or vessels in the lower extremities; opioid use before inclusion in the study; regular use of cannabis or cannabinoids; severe mental illness; severe impairment of cognitive function; pregnancy or lactation obesity (BMI>35 kg/m2); • Randomization and Intervention After screening for inclusion/exclusion criteria, eligible participants signed the written informed consent and completed the baseline assessments that included a quantitative sensory test using the SWM and patient-reported outcome measurements, and the nerve conduction study. Eligible participants completed the baseline assessments within seven days before the interventions. According to the previous randomization assignment, each patient will be assigned to 2 groups: (1) the laser acupuncture group and (2) the sham laser acupuncture group. Only the statistician aware of the randomized order for each participant. Each participant will receive 24 interventions within 8 weeks, including three interventions per week for 8 weeks. The selected acupoints for laser acupuncture and electro-acupuncture were the same real acupoints, including bilateral LI 4, PC6, LI11, GB 34, ST 36, SP 6, KI 3, LR 3。 • Statistical analysis All data will be analyzed using IBM® SPSS® Statistics version 22 (Statistical Product and Service Solutions Statistics, I.B.M., Inc., Armonk, NY, USA). For demographic data, continuous data will be analyzed using a two-sample t-test or Mann-Whitney U test, while categorical data will be analyzed using Fisher's exact test. If the data of each group fail to pass the Shapiro-Wilk normal distribution test (all p value < 0.05), the between-group differences will be examined using the nonparametric Mann-Whitney U test, and the intra-group differences will be examined using the Wilcoxon signed-rank test. If the measurements of the baseline values will be as per the Shapiro-Wilk normal distribution test (all p value > 0.05), the difference between groups will be examined using a two-sample t-test, and the intra-group difference was examined using a paired t-test. Differences between or within groups were considered significant at p < 0.05.

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, laser acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomized to either the laser acupuncture, the sham laser acupuncture group using a block randomization method with allocation ratio of 1:1. According to the previous randomization assignment, each patient will be assigned to 2 groups: (1) the laser acupuncture group and (2) the sham laser acupuncture group. Only the statistician is aware of the randomized order for each participant. Each participant will receive 24 interventions within 8 weeks, including three interventions per week for 8 weeks.
Masking
ParticipantOutcomes Assessor
Masking Description
Before study commencement, the statistician created a randomization sequence using IBM® SPSS® Statistics and contained it in sealed envelopes. The balanced sample size was ensured by dividing the participants into blocks of two. All eligible participants and assessors were unaware of the assignment order. Both the physician and participants will be unaware of the group allocation. Participants were allowed to withdraw from the study at any time.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser acupuncture group
Arm Type
Experimental
Arm Description
This study will use the Handylaser Trion laser manufactured by RJ Laser, Germany. It will be used for 40 seconds to deliver 6 J of energy as a pulsed wave (Noiger E) at each acupoint near palms or plantar, such as bilateral LI 4, PC6, KI 3, LR 3. For distal points in the four limbs, the laser will be used for 40 seconds at each acupoint to deliver 6J of energy as a pulsed wave (Noiger B), such as bilateral LI11, GB 34, ST 36, SP 6.
Arm Title
sham laser acupuncture group
Arm Type
Sham Comparator
Arm Description
This study will use the sham Handylaser Trion laser manufactured by RJ Laser, without any laser beam delivering. The acupoints of the sham-laser acupuncture are the same as those of the laser acupuncture group.
Intervention Type
Device
Intervention Name(s)
laser acupuncture
Intervention Description
This study will use the Handylaser Trion laser manufactured by RJ Laser, Germany.
Intervention Type
Device
Intervention Name(s)
sham laser acupuncture
Intervention Description
This study will use the sham Handylaser Trion laser manufactured by RJ Laser, Germany,and without any laser beam delivering
Primary Outcome Measure Information:
Title
the Brief Pain Inventory-Short Form
Description
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form(Ger, et al. 1999) (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.
Time Frame
BPI-SF will be assessed at the baseline
Title
the Brief Pain Inventory-Short Form
Description
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form(Ger, et al. 1999) (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.
Time Frame
BPI-SF will be assessed at the 4th week
Title
the Brief Pain Inventory-Short Form
Description
The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form(Ger, et al. 1999) (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.
Time Frame
BPI-SF will be assessed at the 8th week
Secondary Outcome Measure Information:
Title
The Michigan Neuropathy Screening Instrument (MNSI)
Description
The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument, the history questionnaire, consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical assessment (completed by health professionals) involving:1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection; 2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe; 3) grading of ankle reflexes and 4) monofilament testing. Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation.
Time Frame
MNSI will be assessed at the baseline
Title
The Michigan Neuropathy Screening Instrument (MNSI)
Description
The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. The first part of the screening instrument, the history questionnaire, consists of 15 self-administered "yes or no" questions on foot sensation including pain, numbness and temperature sensitivity. A higher score (out of a maximum of 13 points) indicates more neuropathic symptoms. The second part of the MNSI is a brief physical assessment (completed by health professionals) involving:1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection; 2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe; 3) grading of ankle reflexes and 4) monofilament testing. Patients screening positive on the clinical portion of the MNSI (greater than 2 points on a 10 point scale) are considered neuropathic and referred for further evaluation
Time Frame
MNSI will be assessed at the 8th week
Title
Semmes-Weinstein Monofilament(SWM)
Description
SWM is a clinically easy-to-administer, quantifiable, and reliable tool for evaluating protective sensation loss(Kamei, et al. 2005). Measurements were performed using a set of 20 von Frey monofilaments (Semmes-Weinstein von Frey Aesthesiometer, Stoelting Co., Wood Dale, IL, USA), with evaluator size/target forces ranging from 1.65/0.008 g to 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Measurement sites included the sole, tip of the big toe, palm, and tip of the middle finger. All tests were performed by an independent assessor who was blinded to the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer.
Time Frame
SWM will be assessed at the baseline
Title
Semmes-Weinstein Monofilament(SWM)
Description
SWM is a clinically easy-to-administer, quantifiable, and reliable tool for evaluating protective sensation loss(Kamei, et al. 2005). Measurements were performed using a set of 20 von Frey monofilaments (Semmes-Weinstein von Frey Aesthesiometer, Stoelting Co., Wood Dale, IL, USA), with evaluator size/target forces ranging from 1.65/0.008 g to 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Measurement sites included the sole, tip of the big toe, palm, and tip of the middle finger. All tests were performed by an independent assessor who was blinded to the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer.
Time Frame
SWM will be assessed at the 8th week
Title
Nerve conduction velocity (NCV)
Description
NCV will be performed on both lower extremities at baseline and the week 8 (the end of treatment). Peroneal motor nerve conduction velocity (MNCV), sural sensory nerve conduction velocity (SNCV), and tibial motor nerve conduction velocity (MNCV) will be measured.
Time Frame
NCV will be assessed at the baseline
Title
Nerve conduction velocity (NCV)
Description
NCV will be performed on both lower extremities at baseline and the week 8 (the end of treatment). Peroneal motor nerve conduction velocity (MNCV), sural sensory nerve conduction velocity (SNCV), and tibial motor nerve conduction velocity (MNCV) will be measured.
Time Frame
NCV will be assessed at the 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female or male patients (aged over 18 years) with diabetes mellitus type II. patients have symptoms (numbness, tingling, burning, stabbing, shooting pain, etc.) and signs (symmetric decreased distal sensation, or decreased or absent ankle reflexes) of diabetic neuropathy. presence of abnormal nerve conduction study, or presence of neuropathy is likely tested by Semmes-Weinstein 10-g monofilament, or decreased vibration sensation tested by 128Hz vibration tuning fork patients who have completed titration of pain medication or stopped accepting physical therapy against DPN; must provide written informed consent. Exclusion Criteria: severe DPN with muscular weakness of the proximal leg muscles; neuropathy due to other reasons (such as HIVD, malignancy, severe renal disease, hepatitis, thyroid disease, vitamine B12 deficiency, virus infection (such as: human immunodeficiency virus infection, etc), syphilis, alcohol, neurotoxic drug use, inflammatory disease (such as chronic inflammatory demyelinating polyneuropathy), heavy metal intoxication, hereditary disease, etc) severe peripheral artery disease in Fontaine stage IV(Focal tissue necrosis, ulceration or gangrene); traumatic lesions of the nerves or vessels in the lower extremities; opioid use before inclusion in the study; regular use of cannabis or cannabinoids; severe mental illness; severe impairment of cognitive function; pregnancy or lactation obesity (BMI>35 kg/m2)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Chen Huang, PhD
Phone
886-6-3553111
Ext
2231
Email
chenchinh2013@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Chen Chiu, MD
Phone
886-988517633
Email
epsilonee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Hung Chen, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tainan Municipal An Nan Hospital-China Medical University
City
Tainan
ZIP/Postal Code
709
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Chen Huang, Ph.D.
Phone
886-912125682
Email
chenchinh2013@gmail.com
First Name & Middle Initial & Last Name & Degree
Yi-Hung Chen, PhD
Phone
886-4-22053366
Ext
3607
Email
yihungchen@mail.cmu.edu.tw

12. IPD Sharing Statement

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Laser Acupuncture on Diabetes-induced Peripheral Neuropathy

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