Clinical trial NCT05521737: Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy
Official title: Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: National Polytechnic Institute, Mexico
name: Instituto Nacional de Salud Publica, Mexico
name: Escuela Superior de Medicina, Instituto Politécnico Nacional
name: Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional
name: Universidad Nacional Autonoma de Mexico
name: Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de Mexico
name: Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de Mexico
name: Facultad de Medicina, UNAM
First posted: 2022-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Detailed description: Controlled clinical trial to evaluate the effect of electroacupuncture on the reduction of neuropathic pain, quality of life; electrophysiological, inflammatory response, oxidative stress, and genetic expression, in patients with type 2 diabetes mellitus, beneficiaries from the family medical centers 20 , 40 and 41 of the Instituto Mexicano del Seguro Social, at north of Mexico City.

Once the acceptance letter has been signed, a series of questionnaires (MNSI, MDNS, DN-4, NRS, and SF-36), and a physical examination will be carried out to meet the necessary criteria to continue participating.

Only candidates with clinical diagnosis of diabetic polyneuropathy will have an electrophysiological examination by nerve conduction velocity study, if so, patients will be randomized to the electroacupunture or sham acupuncture groups.

Before intervention, laboratory studies will be taken after fasting for 8 to 10 hours, to determine biochemichal profile (glucose, urea, creatinine, uric acid , triglycerides, total cholesterol, HDL and LDL), oxidative stress (Malondialdehyde), inflammatory response (IL-6, IL1β, TNF-α, IL-10 and IL-18 cytokines), and gene expression (5-HT1AR, Neurokinin 1, α-adrenoreceptors, NGF, CX3CR1, GAP-43, and NT3).

Intervention will be applied in a total of 32 acupuncture sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between.

At the end of both cycles of interventions, the questionnaires, the nerve conduction velocity study the biochemical and molecular studies will be re-assessed. Finally, this will be re-evaluated after three months post-intervention in order to evaluate the effect of intervention over time.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Nerve Conduction Velocity
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Secondary outcomes:
measure: Michigan Neuropathy Screening Instrument (MNSI).
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
measure: Michigan Diabetic Neuropathy Score (MDNS)
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
measure: Douleur Neuropathique en 4 Questions (DN-4)
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
measure: Numerical Pain Rating Scale (NRS)
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
measure: Quality life (SF-36)
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
measure: Oxidative Stress
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
measure: Inflammatory response
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
measure: Genetic expression
timeFrame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Medical research unit in biochemistry, UMAE "Dr. Bernardo Sepúlveda".Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social.
state: Cuauhtémoc
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: José de Jesús Peralta Romero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.