Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy
NCT ID: NCT05521737
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-11-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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Sham group
Sham acupuncture will be administered in a total of 32 sessions within five months.
Sham Acupuncture
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.
Interventional group
Electroacupuncture will be administered in a total of 32 sessions within five months.
Electroacupuncture
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).
Interventions
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Electroacupuncture
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).
Sham Acupuncture
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with clinical diabetic peripheral polyneuropathy.
* Patients with electrophysiological diagnosis of diabetic peripheral polyneuropathy in its different types of classification.
Exclusion Criteria
* 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.
40 Years
75 Years
ALL
No
Sponsors
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National Polytechnic Institute, Mexico
OTHER
Instituto Nacional de Salud Publica, Mexico
OTHER
Escuela Superior de Medicina, Instituto Politécnico Nacional
UNKNOWN
Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional
UNKNOWN
Universidad Nacional Autonoma de Mexico
OTHER
Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de Mexico
UNKNOWN
Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de Mexico
UNKNOWN
Facultad de Medicina, UNAM
UNKNOWN
Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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José de Jesús Peralta Romero
Principal investigator, head of clinical department of the Medical Research Unit in Biochemistry, UMAE
Principal Investigators
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José de Jesús Peralta Romero, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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Medical research unit in biochemistry, UMAE "Dr. Bernardo Sepúlveda".Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social.
Mexico City, Cuauhtémoc, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol: COMITEE PROTOCOL REAPPROVAL 2022 - 2023
Document Type: Study Protocol: COMITEE PROTOCOL APPROVAL 2020 - 2021
Document Type: Study Protocol: COMITEE PROTOCOL REAPPROVAL 2021 - 2022
Document Type: Study Protocol: Publication of Study Protocol
Document Type: Study Protocol: RESEARCH COMITEE PROTOCOL REAPPROVAL 2023 - 2024
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Study Documents
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Document Type: Protocol reapproval report
View DocumentOther Identifiers
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09-CEI-009-20160601
Identifier Type: OTHER
Identifier Source: secondary_id
17 CI 09 015 006
Identifier Type: OTHER
Identifier Source: secondary_id
R-2020-785-070
Identifier Type: -
Identifier Source: org_study_id
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