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IRCT20250602066020N1 IRCT 2025-06-27 University of social welfare and rehabilitation sciences Effects of transcutaneous auricular vagus nerve stimulation On diabetic neuropathy Effects of transcutaneous auricular vagus nerve stimulation On lower limb nerve conduction velocity and perfusion, foot neuropathic pain and quality of life in individuals with type 2 diabetes-double blined controlled clinical trial 2025-06-22 anticipated 20 Recruiting https://irct.ir/trial/84269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: If patients meet the eligibility criteria for the study, they will be randomly assigned to either the intervention or control group using the block randomization method. Patients will be blinded to their group assignment. After conducting a pilot study and determining the final sample size, participants will be divided into blocks. All blocks will be of equal size. For example, in a two-group trial (intervention and control), blocks of 8 participants will be used, with 4 assigned to the intervention group and 4 to the control group. To determine group assignment, a die will be rolled: even numbers will place the participant in the intervention group, and odd numbers will place them in the control group, Blinding description: This study is double-blind: both the patients and the assessors are unaware of group allocation. The study assessors include the individuals performing the NCV test, ABI test, HRV test, and clinical examinations such as touch sensation, vibration, joint position sense, and balance assessments. The person administering the intervention (electrode placement and current adjustment) and the data analyst are not blinded. N/A Diabetic Neuropathic. Intervention 1: Intervention group: Intervention will be performed via the cochlea of ​​both ears for each participant 3 times a week for 4 weeks. Biphasic symmetrical current with a frequency of 2 Hz and a duration of 200 ms and the intensity increases to the patient's tolerance (maximum 5 mA). Intervention 2: Control group: will be performed via the Ear Lobe of ​​both ears for each participant 3 times a week for 4 weeks. Biphasic symmetrical current with a frequency of 2 Hz and a duration of 200 ms and the intensity increases to the patient's tolerance (maximum 5 mA). No - There is not a plan to make this available Justification or reason for not sharing IPD is For Patient Privacy
public Maryam Alizadeh Cham Khale
No 16, Anoshervan Alley, Haddadi St, Qazvin St
Tehran Iran (Islamic Republic of) 1355865491 +98 21 5572 7721 Maryam.Alizadeh9655@gmail.com University of social welfare and rehabilitation sciences scientific Maryam Alizadeh Cham Khale
No 16, Anoshervan Alley, Haddadi St, Qazvin St
Tehran Iran (Islamic Republic of) 1355865491 +98 21 5572 7721 Maryam.Alizadeh9655@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) 1.Diabetic neuropathy/ 2.40 to 75 years old/ 3.Both sex/ 4.EMG Electrodiagnosis of diabetic neuropathy consist of small fiber neuropathy and axonal diabetic neuropathy /5.Hyposthesia/ 6. Distal foot pain/ 7.Pain score of 3 to 7 NPRS/ 8.Reading and writing ability 40 years 75 years Both 1.Non diabetic neuropathy/ 2. cigarette or alcohol usage/ 3.Peripheral artery disease cause to foot ulcer and amputation/ 4. Alternative medicine/ 5.Pregnancy and breast feeding/ 6.Heart arrhythmia and heart battery/ 7.Spin radiculopathy and lower limb fracture/ 8.Do not like to join study E08.610 Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy Treatment - Other Treatment - Other Intervention group: Intervention will be performed via the cochlea of ​​both ears for each participant 3 times a week for 4 weeks. Biphasic symmetrical current with a frequency of 2 Hz and a duration of 200 ms and the intensity increases to the patient's tolerance (maximum 5 mA) Control group: will be performed via the Ear Lobe of ​​both ears for each participant 3 times a week for 4 weeks. Biphasic symmetrical current with a frequency of 2 Hz and a duration of 200 ms and the intensity increases to the patient's tolerance (maximum 5 mA) Pain. Timepoint: Before and After Trial. Method of measurement: Numeric Pain Rating Scale. Sural Nerve NCV. Timepoint: Before and After Trial. Method of measurement: NCV. Medial Plantar Nerve NCV. Timepoint: Before and After Trial. Method of measurement: NCV. Ankle Brachial Index. Timepoint: Before and After Trial. Method of measurement: Pressure Gauge. Quality of Life. Timepoint: Before and After Trial. Method of measurement: Questionnaire. University of social welfare and rehabilitation sciences Approved 2025-06-11 Ethics committee of Social Welfare and Rehabilitation No16, Anooshirvan Alley, Haddadi St, Qazvin St Tehran Tehran Iran (Islamic Republic of)