Laser Acupuncture on Diabetes-induced Peripheral Neuropathy

NCT05921019 | Unknown

• 1 other identifier: ANHRF111-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

diabetic peripheral neuropathy; laser acupuncture

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  BPI-SF will be assessed at the 8th week

Secondary Outcomes (6)

• The Michigan Neuropathy Screening Instrument (MNSI)

  MNSI will be assessed at the baseline

• The Michigan Neuropathy Screening Instrument (MNSI)

  MNSI will be assessed at the 8th week

• Semmes-Weinstein Monofilament(SWM)

  SWM will be assessed at the baseline

• Semmes-Weinstein Monofilament(SWM)

  SWM will be assessed at the 8th week

• Nerve conduction velocity (NCV)

  NCV will be assessed at the baseline

Study Arms (2)

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.

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.

Device: sham laser acupuncture

Interventions

laser acupuncture DEVICE

This study will use the Handylaser Trion laser manufactured by RJ Laser, Germany.

laser acupuncture group

sham laser acupuncture DEVICE

This study will use the sham Handylaser Trion laser manufactured by RJ Laser, Germany,and without any laser beam delivering

sham laser acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• regular use of cannabis or cannabinoids;
• severe mental illness;
• severe impairment of cognitive function;
• pregnancy or lactation
• obesity (BMI\>35 kg/m2)

Sponsors & Collaborators

• Taiwan Municipal An-Nan Hospital-China Medical University: lead

Study Sites (1)

Tainan Municipal An Nan Hospital-China Medical University

Tainan, 709, Taiwan

RECRUITING

Study Officials

• Yi-Hung Chen, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Chen Huang, PhD

CONTACT

886-6-3553111; chenchinh2013@gmail.com

Yu Chen Chiu, MD

CONTACT

886-988517633; epsilonee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 27, 2023
• Study Start: August 31, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

TW (1)