Diabetic Peripheral NeuropathyNCT05921019
Laser Acupuncture on Diabetes-induced Peripheral Neuropathy
A study testing laser acupuncture in people with Diabetic Peripheral Neuropathy, run by Taiwan Municipal An-Nan Hospital-China Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2022to 31 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- severe mental illness;
- severe impairment of cognitive function;
- pregnancy or lactation
- obesity (BMI>35 kg/m2)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tainan Municipal An Nan Hospital-China Medical University
Tainan, 709
Chien-Chen Huang, Ph.D., 886-912125682, chenchinh2013@gmail.com
Yi-Hung Chen, PhD, 886-4-22053366 ext. 3607, yihungchen@mail.cmu.edu.tw
About this study
Official title: The Efficacy of Laser Acupuncture on the Diabetes-induced Peripheral Neuropathy: Basic and Clinical Research
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- laser acupuncture, sham laser acupuncture
- Keywords
- diabetic peripheral neuropathy, laser acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureDevice
This study will use the Handylaser Trion laser manufactured by RJ Laser, Germany.
sham laser acupunctureDevice
This study will use the sham Handylaser Trion laser manufactured by RJ Laser, Germany,and without any laser beam delivering
| Study group | Role | What they receive |
|---|---|---|
| laser acupuncture group | Experimental | 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. Receives: Device: laser acupuncture |
| sham laser acupuncture group | Sham comparator | 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. Receives: Device: sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: BPI-SF will be assessed at the baseline
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.
Measured: BPI-SF will be assessed at the 4th week
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.
Measured: BPI-SF will be assessed at the 8th week
Secondary outcomes (6)
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.
Measured: MNSI will be assessed at the baseline
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
Measured: MNSI will be assessed at the 8th week
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.
Measured: SWM will be assessed at the baseline
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.
Measured: SWM will be assessed at the 8th week
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.
Measured: NCV will be assessed at the baseline
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.
Measured: NCV will be assessed at the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start31 Aug 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (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
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Municipal An-Nan Hospital-China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Chen, Chiu, Taiwan Municipal An-Nan Hospital-China Medical University
- Investigators
- Yi-Hung Chen, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921019
- Sponsor's protocol ID
- ANHRF111-06
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Laser Acupuncture on the Diabetes-induced Peripheral Neuropathy: Basic and Clinical Research
- ClinicalTrials.gov ID
- NCT05921019
- Acronym / sponsor ID
- ANHRF111-06
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- diabetic peripheral neuropathy, laser acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taiwan Municipal An-Nan Hospital-China Medical UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 27 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| laser acupuncture group | Experimental | Device: laser acupunctureThis 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. |
| sham laser acupuncture group | Sham comparator | Device: sham laser acupunctureThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| laser acupunctureThis study will use the Handylaser Trion laser manufactured by RJ Laser, Germany. | Device | laser acupuncture group |
| sham laser acupunctureThis study will use the sham Handylaser Trion laser manufactured by RJ Laser, Germany,and without any laser beam delivering | Device | sham laser acupuncture group |
Primary outcome
the Brief Pain Inventory-Short Form
Time frame: BPI-SF will be assessed at the baseline
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
Time frame: BPI-SF will be assessed at the 4th week
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
Time frame: BPI-SF will be assessed at the 8th week
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.
6 secondary outcomes
The Michigan Neuropathy Screening Instrument (MNSI)
Time frame: MNSI will be assessed at the baseline
The Michigan Neuropathy Screening Instrument (MNSI)
Time frame: MNSI will be assessed at the 8th week
Semmes-Weinstein Monofilament(SWM)
Time frame: SWM will be assessed at the baseline
Semmes-Weinstein Monofilament(SWM)
Time frame: SWM will be assessed at the 8th week
Nerve conduction velocity (NCV)
Time frame: NCV will be assessed at the baseline
Nerve conduction velocity (NCV)
Time frame: NCV will be assessed at the 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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.
Yi-Hung Chen, PhD principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture in people with Diabetic Peripheral Neuropathy, run by Taiwan Municipal An-Nan Hospital-China Medical University at 1 site in Taiwan.
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 10 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 27 Jun 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 Taiwan. 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 Chien-Chen Huang, PhD (886-6-3553111 ext. 2231, chenchinh2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Brief Pain Inventory-Short Form (time frame: BPI-SF will be assessed at the baseline). The study lists 3 primary outcomes in all. 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 27 Jun 2023.