Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy

NCT05521737 | Recruiting DMC

• 3 other identifiers: R-2020-785-07009-CEI-009-2016060117 CI 09 015 006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a controlled clinical trial with the aim to study the effects of electroacupuncture on neuropathic pain reduction, quality of life and changes in sensory and motor nerve conduction velocity in patients with type 2 diabetes mellitus, beneficiaries of the familiar medical centers 20, 40 and 41 of the Instituto Mexicano del Seguro Social, at north of Mexico City, in colaboration with the human acupuncture specialty of the Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico.

Conditions

Electroacupuncture; Acupuncture; Diabetic Polyneuropathy; Diabetic Peripheral Neuropathy; Diabetic Peripheral Neuropathic Pain; Nerve Conduction

Keywords

Electroacupuncture; Acupuncture; Diabetic Polyneuropathy; Diabetic Peripheral Neuropathy; Diabetic Peripheral Neuropathic Pain; Nerve Conduction; Diabetic Pain

Outcome Measures

Primary Outcomes (1)

• Nerve Conduction Velocity

  Measured by Nerve Conduction Velocity Study using the VIKING LIFE-SAVING EQUIPMENT, to determine Motor and Sensitive Nerve Conduction Velocity of common peroneal nerve, sural nerve, and tibial nerve. Sensitive Nerve Conduction (SCV). Distance between the receiving point and the stimulus point. SCV normal values: Peroneal nerve ≥ 41 m/s, tibial nerve ≥ 44 m/s, sural nerve ≥ 50 m/s. Motor Conduction Velocity (MCV). Distance between two points and the difference in incubation between them after superstimulation of the corresponding nerve branch. MCV normal values: Peroneal nerve ≥ 41 m/s, tibial nerve ≥ 44 m/s, sural nerve ≥ 60 m/s. \*Values below those stipulated above indicate that NCV has slowed down, and is abnomal. The investigators expect a diminishment of SCV and MCV in sham acupuncture group from the first cycle of intervention whereas electroacupuncture group remains unchanged or even increases SCV and MCV.

  Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.

Secondary Outcomes (8)

• Michigan Neuropathy Screening Instrument (MNSI).

  Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.

• Michigan Diabetic Neuropathy Score (MDNS)

  Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.

• Douleur Neuropathique en 4 Questions (DN-4)

  Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.

• Numerical Pain Rating Scale (NRS)

  Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.

• Quality life (SF-36)

  Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.

Study Arms (2)

Sham group

SHAM COMPARATOR

Sham acupuncture will be administered in a total of 32 sessions within five months.

Procedure: Sham Acupuncture

Interventional group

EXPERIMENTAL

Electroacupuncture will be administered in a total of 32 sessions within five months.

Procedure: Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

Intervention consists of a total of 32 sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between. EA is applied for 20 minutes at an alternating frequency of 2 Hz. Acupunctural points are Zusanli (E36), Fenlong (E40), Yinlingquan (B9), Sanyinjiao (B6), Taichong (H3) and Zulinqi (VB41).

Also known as: EA

Interventional group

Sham Acupuncture PROCEDURE

Intervention consists of a total of 32 sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between. Sham acupuncture will be applied using a nonpuncture device without electrical stimulation at the same acupunctural points as in the EA group.

Also known as: Sham

Sham group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes.
• Patients with clinical diabetic peripheral polyneuropathy.
• Patients with electrophysiological diagnosis of diabetic peripheral polyneuropathy in its different types of classification.

You may not qualify if:

• Type 1 Diabetes or gestational diabetes.
• Systemic autoimmune diseases.
• Hematological disorders.
• HIV diagnosis.
• Cancer in treatment.
• Pregnancy.
• Other types of neurological disorders or neuropathies.
• Intervention with acupuncture six months previously.
• Patients with pacemarkers.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• National Polytechnic Institute, Mexico: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator
• Escuela Superior de Medicina, Instituto Politécnico Nacional: collaborator
• Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator
• Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de Mexico: collaborator
• Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de Mexico: collaborator
• Facultad de Medicina, UNAM: collaborator

Study Sites (1)

Medical research unit in biochemistry, UMAE "Dr. Bernardo Sepúlveda".Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social.

Mexico City, Cuauhtémoc, 06720, Mexico

RECRUITING

Related Publications (2)

• Perez Hernandez MF, Calderon Vallejo A, Aguilar Castillo SJ, Gomez Jimenez DC, Rodriguez Guerrero E, Aguilar Morales F, Moreno Tovar MG, Zurita Munoz MA, Bautista Cortez AE, Calzada Mendoza CC, De Nova Ocampo MA, Ordonez Rodriguez JM, Gomez Esquivel ML, Garcia Mendez A, Flores Gil O, Macias Zaragoza VM, Cortes Moreno GY, Salinas Lara C, Velazquez Garcia G, Saldivar Ceron HI, Perez Navarro LM, Avila Jimenez L, Gomez Zamudio JH, Diaz Flores M, Cruz Lopez M, Ocharan Hernandez ME, Peralta Romero JJ. Electroacupuncture efficacy in diabetic polyneuropathy: Study protocol for a double-blinded randomized controlled multicenter clinical trial. BMC Complement Med Ther. 2024 Feb 15;24(1):90. doi: 10.1186/s12906-024-04375-8.

  PMID: 38360684 BACKGROUND

• Perez Hernandez MF, Rodriguez Guerrero E, Ocharan Hernandez ME, Gomez Jimenez DC, Gomez Esquivel ML, Aguilar Castillo SJ, Flores Hernandez VD, Romo Duenas S, Torres Mendoza MR, Calderon Vallejo A, Velazquez Garcia G, Moreno Tovar MG, Cruz Lopez M, Ordonez Rodriguez JM, Pena Juarez KA, Miranda Gastelum X, Castro Diaz JM, Aguirre Guerrero A, Macias Zaragoza VM, Peralta Romero JJ. Effect of electroacupuncture for pain relief in diabetic distal symmetric polyneuropathy: a pilot randomized clinical trial. BMC Complement Med Ther. 2025 Dec 9;25(1):438. doi: 10.1186/s12906-025-05135-y.

  PMID: 41366387 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Electroacupuncture; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• José de Jesús Peralta Romero, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José de Jesús Peralta Romero, PhD

CONTACT

5532318563; drjjperalta@gmail.com

María Fernanda Pérez Hernández, MsC

CONTACT

5574021093; marferperezh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient masking: During the application of the intervention, a bandage is placed over the patients eyes so that the participants cannot see the type of therapy applied (electroacupuncture or sham acupuncture). Statistical masking: The researcher in charge of the statistical analysis is unaware of the type of intervention received by the patients and delivers the results to the responsible researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, head of clinical department of the Medical Research Unit in Biochemistry, UMAE

Model Details: The protocol consists of two study groups, including a control group of sham acupuncture, and an interventional group of Electroacupuncture. Both interventions will be applied in a total of 32 sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between. ,Acupuncture points are Zusanli (E36), Fenlong (E40), Yinlingquan (B9), Sanyinjiao (B6), Taichong (H3) and Zulinqi (VB41).

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: November 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)