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IRCT20181006041252N13 IRCT 2019-06-27 Sabzevar University of Medical Sciences The effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN). Investigating the effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN). 2019-06-26 anticipated 50 Complete https://irct.ir/trial/40389 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A and B are available to the researcher, Accordingly, 13 blocks were allocated to patients, in each block, 2 from A treatment group, 2 from the B treatment group were placed. Eventually, after completing the blocks group A was treated with Group A is treated with acupuncture and Group B is being treated with placebo (sham acupuncture). First, we determine all sixsome modes in which two individuals are assigned to group A and two to group B. Then we assign one of the digits 1 to 6 to each of the sixsome combinations (which includes thirty-six modes). In the next step, we must randomly select 13 blocks of six and write their combinations in succession. For this we have to make 13 samplings with replacement from a six-member community; 6 times, choose a random number between 1 and 6 and this process will continue until the end of the sampling and the difference between the two groups will not exceed a maximum of two (half the size of the block), Blinding description: Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. Participants are unaware of the groups. It should be noted that acupuncture and placebo (sham acupuncture) are similar in appearance, color, and packaging. 3 Diabetes-related peripheral neuropathy (DPN).. Intervention 1: Intervention group: The treatment group, in addition to routine therapies, will be treated with real acupuncture as a complementary therapy for seven sessions and once a week for 20 minutes each session. Treatment in this group will be in 9 specific areas of the body. These points are marked with standard stainless needles (0.3 mm diameter, 40 mm length, Korea) and stimulated for 20 minutes manually for acupuncture stimulation elicits (DEQI). During the study period, each week will be evaluated for the improvement of neuropathy symptoms. Intervention 2: Control group: The control group will only be treated under the usual treatment of neuropathy and sham acupuncture. Acupuncture will be unrealistic for seven sessions and once a week. In this study, we will use the Streitberger devices. The needle is not fixed inside the copper cloth and the tip is blunt, and when it touches the skin, the feeling of itching is felt in the patient (simulating skin piercing). For the sham acupuncture group, points that are at least 1.5 centimeters away from the 9 main real acupuncture points will be used. During the study period, each week will be evaluated for the improvement of neuropathy symptoms. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Mohammad Sahebkar
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8337 Mohammad.Sahebkar66@gmail.com Sabzevar University of Medical Sciences scientific Dr. Najmeh Rahimi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8337 rahimy.najmeh@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Patients with their neuropathy are caused by type 1 and type 2 diabetes Patients with a pain score of 3 or more are in the form of an assessment of the visual scale of the pain. Patients aged 40 to 60 years. Patients with at least 10 years of diabetes. 40 years 60 years Both Patients with diabetic foot ulcer Patients who drink alcohol or use tobacco. Patients who use immunosuppressive drugs have interfered with the interpretation of results. Patients whose neuropathy is caused by other disorders, such as carpal tunnel syndrome, AIDS, etc. Unwillingness to complete questionnaires and do acupuncture E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Other Treatment - Other Intervention group: The treatment group, in addition to routine therapies, will be treated with real acupuncture as a complementary therapy for seven sessions and once a week for 20 minutes each session. Treatment in this group will be in 9 specific areas of the body. These points are marked with standard stainless needles (0.3 mm diameter, 40 mm length, Korea) and stimulated for 20 minutes manually for acupuncture stimulation elicits (DEQI). During the study period, each week will be evaluated for the improvement of neuropathy symptoms. Control group: The control group will only be treated under the usual treatment of neuropathy and sham acupuncture. Acupuncture will be unrealistic for seven sessions and once a week. In this study, we will use the Streitberger devices. The needle is not fixed inside the copper cloth and the tip is blunt, and when it touches the skin, the feeling of itching is felt in the patient (simulating skin piercing). For the sham acupuncture group, points that are at least 1.5 centimeters away from the 9 main real acupuncture points will be used. During the study period, each week will be evaluated for the improvement of neuropathy symptoms. Determine the amount of pain. Timepoint: Measuring the amount of pain at the beginning of the study (before the intervention) and at the end of each session for seven sessions (weekly) after the start of the intervention. Method of measurement: Visual Analogue Scale (VAS). Determine fatigue. Timepoint: Fatigue measurement at the beginning of the study (before the intervention) and at the end of each session for seven sessions (weekly) after the start of the intervention. Method of measurement: Multidimensional Fatigue Inventory-20= MFI-20. Sabzevar University of Medical Sciences Approved 2019-06-15 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)