ElectroacupunctureEA&DPNNCT05521737
Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy
A study testing Electroacupuncture in people with Electroacupuncture and Acupuncture, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Electroacupuncture, Acupuncture, Diabetic Polyneuropathy
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Type 1 Diabetes or gestational diabetes.
- Systemic autoimmune diseases.
- Hematological disorders.
- HIV diagnosis.
- Cancer in treatment.
- Pregnancy.
Show all 9Show fewer
- Other types of neurological disorders or neuropathies.
- Intervention with acupuncture six months previously.
- Patients with pacemarkers.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Medical research unit in biochemistry, UMAE "Dr. Bernardo Sepúlveda".Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social.
Mexico City, Cuauhtémoc, 06720
José de Jesús Peralta Romero, PhD, 5532318563, drjjperalta@gmail.com
María Fernanda Pérez Hernández, MsC, 5574021093, marferperezh@gmail.com
About this study
Official title: Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes
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.
Read the 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.
- Conditions
- Electroacupuncture, Acupuncture, Diabetic Polyneuropathy, Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain, Nerve Conduction
- Being tested
- Electroacupuncture, Sham Acupuncture
- Keywords
- Electroacupuncture, Acupuncture, Diabetic Polyneuropathy, Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain, Nerve Conduction, Diabetic Pain
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Also called EA
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 AcupunctureProcedure or surgery
Also called Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham group | Sham comparator | Sham acupuncture will be administered in a total of 32 sessions within five months. Receives: Procedure: Sham Acupuncture |
| Interventional group | Experimental | Electroacupuncture will be administered in a total of 32 sessions within five months. Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
It will be assessed with a lower extremity examination by a health professional of both feet in search of deformities, dry skin, calluses, infections, fissures and ulcers. Complemented with measurement of vibratory sensation, ankle reflexes, and Semmes-Weinstein monofilament test.
The investigators expect improvement in the physical aspect of the foot in the electroacupuncture group, while in the sham acupuncture group the complication progresses.
Measured: 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)
Composed of three items where the sensory compromise is evaluated with the perception of vibration, 10 gr. monofilament and pin prick, in addition to the muscular strength of the toes, and the bicipital, tricipital, quadriceps and achilles muscle reflexes. The investigators expect a diminishment of MDNS score and clinical improvement in the electroacupuncture group and progression of clinical manifestations in the sham group.
Measured: 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)
A screening tool for neuropathic pain consisting of 10 interview questions (DN4-interview) and physical tests. A score greater than 4 points suggests neuropathic pain. The investigators expect decreased scores in the electroacupuncture group and increased or persistent scores in the sham group.
Measured: 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)
Patients are only asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that best matches the intensity of their pain currently and in the last 7 days, where zero usually represents "no pain", while the upper limit represents "the worst pain of their life". The investigators expect diminishment of rating scale in electroacupuncture group and an increase in sham acupuncture group.
Measured: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Quality life (SF-36)
It will be measured by The Short Form-36 Health Survey (SF-36) a measure of health status that consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. The investigators expect quality life improvement in electroacupuncture group while in sham acupuncture group might worsen.
Measured: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Oxidative Stress
Determined by quantifying the concentrations of the lipoperoxidation product Malondialdehyde (MDA). An increase of MDA is expected in the sham group, while in the electroacupuncture group it is expected to decrease.
Measured: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Inflammatory response
Assessed by changes in serum concentrations of proinflammatory (IL-6, IL1β, TNF-α and IL-18) and anti-inflammatory (IL-10) cytokines determined by quantitative ELISA by flow cytometry. The investigators expect increase of anti-inflammatory cytokine and decrease of proinflammatory cytokines in the electroacupuncture group, while in the sham group this is inversely presented.
Measured: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Genetic expression
mRNA expression of 5-HT1AR, Neurokinin 1, α-adrenoreceptors, NGF (Nerve growth factor), CX3CR1, GAP-43 (Growth associated protein 43) and Neurotrophin (NT3), (Chemoline receptor 1) genes quantified by real-time PCR. The investigators expect an increase in gene expression in patients with electroacupuncture while in sham patients it is decreased or even unchanged.
Measured: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ElectroacupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- National Polytechnic Institute, Mexico, Instituto Nacional de Salud Publica, Mexico, Escuela Superior de Medicina, Instituto Politécnico Nacional, Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Universidad Nacional Autonoma de Mexico, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de Mexico, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de Mexico, Facultad de Medicina, UNAM
- Responsible party
- Principal investigator, José de Jesús Peralta Romero, Instituto Mexicano del Seguro Social
- Investigators
- José de Jesús Peralta Romero, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521737
- Sponsor's protocol ID
- R-2020-785-070
- Other IDs
- 09-CEI-009-20160601, 17 CI 09 015 006
- Acronym
- EA&DPN
- Status last verified
- May 2024
- First submitted
- 22 Aug 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38360684Perez 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.
PubMed 41366387
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes
- ClinicalTrials.gov ID
- NCT05521737
- Acronym / sponsor ID
- EA&DPN / R-2020-785-070
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- National Polytechnic Institute, Mexico, Instituto Nacional de Salud Publica, Mexico, Escuela Superior de Medicina, Instituto Politécnico Nacional, Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Universidad Nacional Autonoma de Mexico, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de Mexico, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de Mexico, Facultad de Medicina, UNAM
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Sham group | Sham comparator | Procedure: Sham AcupunctureSham acupuncture will be administered in a total of 32 sessions within five months. |
| Interventional group | Experimental | Procedure: ElectroacupunctureElectroacupuncture will be administered in a total of 32 sessions within five months. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Type 1 Diabetes or gestational diabetes.
- Systemic autoimmune diseases.
- Hematological disorders.
- HIV diagnosis.
- Cancer in treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAlso: EAIntervention 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). | Procedure or surgery | Interventional group |
| Sham AcupunctureAlso: ShamIntervention 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. | Procedure or surgery | Sham group |
Primary outcome
Nerve Conduction Velocity
Time frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
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.
8 secondary outcomes
Michigan Neuropathy Screening Instrument (MNSI).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Quality life (SF-36)
Time frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Oxidative Stress
Time frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Inflammatory response
Time frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Genetic expression
Time frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 38360684Perez 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.
- Derived from this study: PubMed 41366387Perez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José de Jesús Peralta Romero, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Electroacupuncture and Acupuncture, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José de Jesús Peralta Romero, PhD (5532318563, drjjperalta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve Conduction Velocity (time frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521737, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.