PMID- 38360684
OWN - NLM
STAT- MEDLINE
DCOM- 20240219
LR  - 20240219
IS  - 2662-7671 (Electronic)
IS  - 2662-7671 (Linking)
VI  - 24
IP  - 1
DP  - 2024 Feb 15
TI  - Electroacupuncture efficacy in diabetic polyneuropathy: Study protocol for a 
      double-blinded randomized controlled multicenter clinical trial.
PG  - 90
LID - 10.1186/s12906-024-04375-8 [doi]
LID - 90
AB  - BACKGROUND: Diabetic peripheral neuropathy (DPN) is the most common complication 
      of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on 
      symptomatic improvement. However, as pharmacological therapy causes multiple 
      adverse effects, the implementation of acupunctural techniques, such as 
      electroacupuncture (EA) has been suggested as an alternative treatment. 
      Nonetheless, there is a lack of scientific evidence, and its mechanisms are still 
      unclear. We present the design and methodology of a new clinical randomized 
      trial, that investigates the effectiveness of EA for the treatment of DPN. 
      METHODS: This study is a four-armed, randomized, controlled, multicenter clinical 
      trial (20-week intervention period, plus 12 weeks of follow-up after concluding 
      intervention). A total of 48 T2DM patients with clinical signs and symptoms of 
      DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be 
      treated by acupuncture specialists in outpatient units in Mexico City. Patients 
      will be randomized in a 1:1 ratio to one of the following four groups: (a) short 
      fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and 
      (d) axonal DPN with sham EA treatment. The intervention will consist of 32 
      sessions, 20 min each, per patient over two cycles of intervention of 8 weeks 
      each and a mid-term rest period of 4 weeks. The primary outcome will be NCS 
      parameters, and secondary outcomes will include DPN-related symptoms and pain by 
      Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy 
      Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, 
      Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form 
      Health Survey (SF-36). To measure quality of life and improve oxidative stress, 
      the inflammatory response; and genetic expression; will be analysed at the 
      beginning and at the end of treatment. DISCUSSION: This study will be conducted 
      to compare the efficacy of EA versus sham EA combined with conventional diabetic 
      and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and 
      symptoms, oxidative stress, inflammatory response, and genetic expression, and it 
      could be considered a potential coadjutant treatment for the management of DPN 
      with a possible remyelinating effect. TRIAL REGISTRATION: ClinicalTrials.gov. 
      NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry 
      Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].
CI  - (c) 2024. The Author(s).
FAU - Perez Hernandez, Maria Fernanda
AU  - Perez Hernandez MF
AD  - Unidad de Investigacion Medica en Bioquimica, Unidad Medica de Alta Especialidad 
      "Dr. Bernardo Sepulveda", Centro Medico Nacional Siglo XXI, IMSS, Mexico City, 
      06720, Mexico.
AD  - Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, 
      Instituto Politecnico Nacional, Mexico City, 11340, Mexico.
AD  - Red MEDICI. Carrera de Medico Cirujano. FES Iztacala, UNAM, Estado de Mexico, 
      State of Mexico, 54090, Mexico.
FAU - Calderon Vallejo, Alejandra
AU  - Calderon Vallejo A
AD  - Departamento de Neurologia de la Unidad Medica de Alta Especialidad "Dr. Bernardo 
      Sepulveda", Centro Medico Nacional Siglo XXI, IMSS, Mexico City, 06720, Mexico.
FAU - Aguilar Castillo, Sergio de Jesus
AU  - Aguilar Castillo SJ
AD  - Departamento de Neurofisiologia de la Unidad Medica de Alta Especialidad "Dr. 
      Bernardo Sepulveda", Centro Medico Nacional Siglo XXI, IMSS, Mexico City, 06720, 
      Mexico.
FAU - Gomez Jimenez, Daniel Cuauhtemoc
AU  - Gomez Jimenez DC
AD  - Seccion de Estudios de Posgrado e Investigacion, Especialidad en Acupuntura 
      Humana, Escuela Nacional de Medicina y Homeopatia, Instituto Politecnico 
      Nacional, Mexico City, 07320, Mexico.
FAU - Rodriguez Guerrero, Eduardo
AU  - Rodriguez Guerrero E
AD  - Seccion de Estudios de Posgrado e Investigacion, Especialidad en Acupuntura 
      Humana, Escuela Nacional de Medicina y Homeopatia, Instituto Politecnico 
      Nacional, Mexico City, 07320, Mexico.
FAU - Aguilar Morales, Fatima
AU  - Aguilar Morales F
AD  - Unidad de Medicina Familiar No. 41, IMSS, Mexico City, 07760, Mexico.
FAU - Moreno Tovar, Macedonia Guadalupe
AU  - Moreno Tovar MG
AD  - Unidad de Medicina Familiar No. 41, IMSS, Mexico City, 07760, Mexico.
FAU - Zurita Munoz, Miguel Alfredo
AU  - Zurita Munoz MA
AD  - Unidad de Medicina Familiar No. 20, IMSS, Mexico City, 07760, Mexico.
FAU - Bautista Cortez, Antonio Eduardo
AU  - Bautista Cortez AE
AD  - Unidad de Medicina Familiar No. 44, IMSS, Mexico City, 07320, Mexico.
FAU - Calzada Mendoza, Claudia Camelia
AU  - Calzada Mendoza CC
AD  - Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, 
      Instituto Politecnico Nacional, Mexico City, 11340, Mexico.
FAU - De Nova Ocampo, Monica Ascencion
AU  - De Nova Ocampo MA
AD  - Seccion de Estudios de Posgrado e Investigacion, Escuela Nacional de Medicina y 
      Homeopatia del Instituto Politecnico Nacional. Maestria en Ciencias en 
      Biomedicina Molecular, Mexico City, 07320, Mexico.
FAU - Ordonez Rodriguez, Juan Manuel
AU  - Ordonez Rodriguez JM
AD  - Seccion de Estudios de Posgrado e Investigacion, Especialidad en Acupuntura 
      Humana, Escuela Nacional de Medicina y Homeopatia, Instituto Politecnico 
      Nacional, Mexico City, 07320, Mexico.
FAU - Gomez Esquivel, Monica Luz
AU  - Gomez Esquivel ML
AD  - Seccion de Estudios de Posgrado e Investigacion, Especialidad en Acupuntura 
      Humana, Escuela Nacional de Medicina y Homeopatia, Instituto Politecnico 
      Nacional, Mexico City, 07320, Mexico.
FAU - Garcia Mendez, Alberto
AU  - Garcia Mendez A
AD  - Unidad de Medicina Familiar No. 41, IMSS, Mexico City, 07760, Mexico.
FAU - Flores Gil, Octavio
AU  - Flores Gil O
AD  - Coordinacion de Internado y Servicio Social, Escuela Nacional de Medicina y 
      Homeopatia, Instituto Politecnico Nacional, Mexico City, 07320, Mexico.
FAU - Macias Zaragoza, Victor Manuel
AU  - Macias Zaragoza VM
AD  - Carrera de Medico Cirujano Facultad de Estudios Superiores Zaragoza, UNAM, Mexico 
      City, 09239, Mexico.
FAU - Cortes Moreno, Gabriela Yanet
AU  - Cortes Moreno GY
AD  - Subdireccion de Servicios de Salud, Petroleos Mexicanos (PEMEX), Mexico City, 
      11311, Mexico.
FAU - Salinas Lara, Citlaltepetl
AU  - Salinas Lara C
AD  - Red MEDICI. Carrera de Medico Cirujano. FES Iztacala, UNAM, Estado de Mexico, 
      State of Mexico, 54090, Mexico.
AD  - Departamento de Neuropatologia, Instituto Nacional de Neurologia y Neurocirugia, 
      Mexico City, 14269, Mexico.
FAU - Velazquez Garcia, German
AU  - Velazquez Garcia G
AD  - Red MEDICI. Carrera de Medico Cirujano. FES Iztacala, UNAM, Estado de Mexico, 
      State of Mexico, 54090, Mexico.
AD  - Carrera de Medico Cirujano Facultad de Estudios Superiores Zaragoza, UNAM, Mexico 
      City, 09239, Mexico.
AD  - Universidad Intercultural del Estado de Mexico Plantel Tepetlixpa, Tepetlixpa, 
      Estado de Mexico, 56880, Mexico.
FAU - Saldivar Ceron, Hector Ivan
AU  - Saldivar Ceron HI
AD  - Red MEDICI. Carrera de Medico Cirujano. FES Iztacala, UNAM, Estado de Mexico, 
      State of Mexico, 54090, Mexico.
AD  - Carrera de Medico Cirujano, Facultad de Estudios Superiores Iztacala, UNAM, 
      Tlalnepantla, State of Mexico, 54090, Mexico.
AD  - Unidad de Biomedicina (UBIMED), Facultad de Estudios Superiores Iztacala, UNAM, 
      Tlalnepantla, State of Mexico, 54090, Mexico.
FAU - Perez Navarro, Lucia Monserrat
AU  - Perez Navarro LM
AD  - Departamento de Nefrologia, Hospital General de Mexico "Dr. Eduardo Liceaga", 
      Mexico City, 06720, Mexico.
FAU - Avila Jimenez, Laura
AU  - Avila Jimenez L
AD  - Coordinacion Auxiliar Medica de Investigacion en Salud, Jefatura de Servicios de 
      Prestaciones Medicas, Delegacion Estatal Morelos, IMSS, Cuernavaca, Morelos, 
      62000, Mexico.
FAU - Gomez Zamudio, Jaime Hector
AU  - Gomez Zamudio JH
AD  - Unidad de Investigacion Medica en Bioquimica, Unidad Medica de Alta Especialidad 
      "Dr. Bernardo Sepulveda", Centro Medico Nacional Siglo XXI, IMSS, Mexico City, 
      06720, Mexico.
FAU - Diaz Flores, Margarita
AU  - Diaz Flores M
AD  - Unidad de Investigacion Medica en Bioquimica, Unidad Medica de Alta Especialidad 
      "Dr. Bernardo Sepulveda", Centro Medico Nacional Siglo XXI, IMSS, Mexico City, 
      06720, Mexico.
FAU - Cruz Lopez, Miguel
AU  - Cruz Lopez M
AD  - Unidad de Investigacion Medica en Bioquimica, Unidad Medica de Alta Especialidad 
      "Dr. Bernardo Sepulveda", Centro Medico Nacional Siglo XXI, IMSS, Mexico City, 
      06720, Mexico.
FAU - Ocharan Hernandez, Maria Esther
AU  - Ocharan Hernandez ME
AD  - Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina, 
      Instituto Politecnico Nacional, Mexico City, 11340, Mexico.
FAU - Peralta Romero, Jose de Jesus
AU  - Peralta Romero JJ
AD  - Unidad de Investigacion Medica en Bioquimica, Unidad Medica de Alta Especialidad 
      "Dr. Bernardo Sepulveda", Centro Medico Nacional Siglo XXI, IMSS, Mexico City, 
      06720, Mexico. drjperalta@hotmail.com.
AD  - Seccion de Estudios de Posgrado e Investigacion, Especialidad en Acupuntura 
      Humana, Escuela Nacional de Medicina y Homeopatia, Instituto Politecnico 
      Nacional, Mexico City, 07320, Mexico. drjperalta@hotmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT05521737
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20240215
PL  - England
TA  - BMC Complement Med Ther
JT  - BMC complementary medicine and therapies
JID - 101761232
SB  - IM
MH  - Humans
MH  - *Diabetic Neuropathies/therapy
MH  - *Electroacupuncture/methods
MH  - *Diabetes Mellitus, Type 2/complications/therapy
MH  - Quality of Life
MH  - *Acupuncture Therapy
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
PMC - PMC10868023
OTO - NOTNLM
OT  - Acupuncture
OT  - Controlled clinical trial
OT  - Diabetes
OT  - Diabetic neuropathy
OT  - Electroacupuncture
COIS- The authors declare no competing interests.
EDAT- 2024/02/16 00:43
MHDA- 2024/02/19 06:44
PMCR- 2024/02/15
CRDT- 2024/02/15 23:39
PHST- 2023/12/28 00:00 [received]
PHST- 2024/01/23 00:00 [accepted]
PHST- 2024/02/19 06:44 [medline]
PHST- 2024/02/16 00:43 [pubmed]
PHST- 2024/02/15 23:39 [entrez]
PHST- 2024/02/15 00:00 [pmc-release]
AID - 10.1186/s12906-024-04375-8 [pii]
AID - 4375 [pii]
AID - 10.1186/s12906-024-04375-8 [doi]
PST - epublish
SO  - BMC Complement Med Ther. 2024 Feb 15;24(1):90. doi: 10.1186/s12906-024-04375-8.