Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Nerve Conduction Velocity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Sham group
Sham acupuncture will be administered in a total of 32 sessions within five months.
Intervention: Sham Acupuncture (Procedure)
Interventional group
Electroacupuncture will be administered in a total of 32 sessions within five months.
Intervention: Electroacupuncture (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Michigan Neuropathy Screening Instrument (MNSI).(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)(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)(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)(Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.)
- Quality life (SF-36)(Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.)
- Oxidative Stress(Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.)
- Inflammatory response(Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.)
- Genetic expression(Baseline evaluation, after the first and second cycle of intervention, respectively, and three months after the end of the intervention.)
Investigators
José de Jesús Peralta Romero
Principal investigator, head of clinical department of the Medical Research Unit in Biochemistry, UMAE
Instituto Mexicano del Seguro Social