Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy (EA&DPN)
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| ClinicalTrials.gov Identifier: NCT05521737 |
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Recruitment Status :
Recruiting
First Posted : August 30, 2022
Last Update Posted : September 29, 2023
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| Condition or disease | Intervention/treatment | Phase |
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| Electroacupuncture Acupuncture Diabetic Polyneuropathy Diabetic Peripheral Neuropathy Diabetic Peripheral Neuropathic Pain Nerve Conduction | Procedure: Electroacupuncture Procedure: Sham Acupuncture | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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). |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes |
| Actual Study Start Date : | November 1, 2021 |
| Estimated Primary Completion Date : | February 2024 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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Sham Comparator: Sham group
Sham acupuncture will be administered in a total of 32 sessions within five months.
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Procedure: 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 Name: Sham |
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Experimental: Interventional group
Electroacupuncture will be administered in a total of 32 sessions within five months.
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Procedure: 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).
Other Name: EA |
- 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.
- 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. ]
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.
- 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. ]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.
- 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. ]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.
- 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. ]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.
- 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. ]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.
- Oxidative Stress [ Time Frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention. ]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.
- Inflammatory response [ Time Frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention. ]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.
- Genetic expression [ Time Frame: Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention. ]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.
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05521737
| Contact: José de Jesús Peralta Romero, PhD | 5532318563 | drjjperalta@gmail.com | |
| Contact: María Fernanda Pérez Hernández, MD | 5574021093 | marferperezh@gmail.com |
| Mexico | |
| Medical research unit in biochemistry, UMAE "Dr. Bernardo Sepúlveda".Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social. | Recruiting |
| Mexico City, Cuauhtémoc, Mexico, 06720 | |
| Contact: José de Jesús Peralta Romero, PhD 5532318563 drjjperalta@gmail.com | |
| Contact: María Fernanda Pérez Hernández, MD 5574021093 marferperezh@gmail.com | |
| Sub-Investigator: Sergio de Jesús Aguilar Castillo, MD | |
| Sub-Investigator: Alejandra Calderón Vallejo, MD | |
| Sub-Investigator: Cuauhtémoc Daniel Gómez Jiménez, MsC | |
| Sub-Investigator: Eduardo Rodríguez Guerrero, MsC | |
| Sub-Investigator: Macedonia Guadalupe Moreno Tovar, MD | |
| Sub-Investigator: Fátima Aguilar Morales, MD | |
| Sub-Investigator: María Esther Ocharan Hernández, PhD | |
| Sub-Investigator: Germán Velázquez García, MsC | |
| Sub-Investigator: Citlaltépetl Salinas Lara, PhD | |
| Sub-Investigator: Claudia Camelia Calzada Mendoza, PhD | |
| Sub-Investigator: Miguel Cruz López, PhD | |
| Principal Investigator: | José de Jesús Peralta Romero, PhD | Instituto Mexicano del Seguro Social |
Documents provided by José de Jesús Peralta Romero, Instituto Mexicano del Seguro Social:
| Responsible Party: | José de Jesús Peralta Romero, Principal investigator, head of clinical department of the Medical Research Unit in Biochemistry, UMAE, Instituto Mexicano del Seguro Social |
| ClinicalTrials.gov Identifier: | NCT05521737 |
| Other Study ID Numbers: |
R-2020-785-070 09-CEI-009-20160601 ( Other Identifier: CONBIOÉTICA ) 17 CI 09 015 006 ( Other Identifier: COFEPRIS ) |
| First Posted: | August 30, 2022 Key Record Dates |
| Last Update Posted: | September 29, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Electroacupuncture Acupuncture Diabetic Polyneuropathy Diabetic Peripheral Neuropathy |
Diabetic Peripheral Neuropathic Pain Nerve Conduction Diabetic Pain |
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Diabetic Neuropathies Peripheral Nervous System Diseases Neuralgia Polyneuropathies Diabetes Mellitus Endocrine System Diseases |
Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Diabetes Complications |