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IRCT20190726044337N1 IRCT 2019-10-20 Shahid Beheshti University of Medical Sciences The Effect of Tecar Therapy on Peripheral Neuropathy in Patients with Type II Diabetes Comparison of the Effectiveness of Infrared radiation and Tecar Therapy with Infrared radiation on Peripheral Neuropathy in Patients with Type II Diabetes 2019-04-08 anticipated 24 Complete https://irct.ir/trial/41280 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization: Patients were assigned a number according to the order of selection and were divided into treatment and control groups by sortition. The first pulled out number was assigned to the treatment group and the subsequent numbers were assigned to the two groups, respectively, Blinding description: Only the Participants of the Study were Blinded and did not know which of the two treatment and control groups were assigned to them.That way, the Individuals in both groups were treated on separate days. 3 Type II Diabetes. Intervention 1: Intervention group: Patients in this group are treated with Infrared radiation (electromagnetic fields with 890 nanometers ,70-80 centimeters away from the surfaces of the foot) for 60 minutes and Capacitive Tecar Therapy (electromagnetic fields with 300-800 Kilohertz and intensity less than 50%) on Tibial nerve pathway with for 20 minutes in each session.Infrared radiation treatment is applied to dorsal, plantar, medial and lateral surface of the feet for twenty minutes and then, the passive electrode of tecar device is placed anterior surface of legs and its active electrode is moved along the tibial nerve pathway for twenty minutes in prone position. Intervention 2: Control group: Patients in this group are treated with Infrared radiation (electromagnetic fields with 890 nanometers , 70-80 centimeters away from the surfaces of the foot) for 60 minutes and Sham Capacitive Tecar Therapy (electromagnetic fields with 300-800 Kilohertz and Zero intensity ) on Tibial nerve pathway with for 20 minutes in each session.Infrared radiation treatment is applied to dorsal, plantar, medial and lateral surface of the feet for twenty minutes and then, the passive electrode of tecar device is placed anterior surface of legs and its active electrode is moved along the tibial nerve pathway for twenty minutes in prone position; except that the current intensity is zero. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No More Information
public Maryam Niajalili
No. 9, Kheyri Alley, Sardar-e Jangal Ave
lahijan Iran (Islamic Republic of) 4418786769 +98 13 4222 4593 Maryam_Niajalili@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Asghar Rezasoltani
School of Rehabilitation Shahid Beheshti University of Medical Science, Damavand Ave, Emam Hossein Sq
Tehran Iran (Islamic Republic of) 1616913111 009877561721 A_rezasoltani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age: 18-75 The least duration of illness affliction was more than six months Patients have type II diabetes Mellitus with signs and Symtoms of mild(I) to moderate(II) Peripheral Neuropathy Pain Intensity which was based on VAS (Visual Analog Scale) scores were more than three 18 years 75 years Both Pregnancy Diabetic Infectious Wound Involvement of Cardiovascular system Involvement of Respiratory system To have Pace maker E11.4 Type 2 diabetes mellitus with neurological complications Rehabilitation Rehabilitation Intervention group: Patients in this group are treated with Infrared radiation (electromagnetic fields with 890 nanometers ,70-80 centimeters away from the surfaces of the foot) for 60 minutes and Capacitive Tecar Therapy (electromagnetic fields with 300-800 Kilohertz and intensity less than 50%) on Tibial nerve pathway with for 20 minutes in each session.Infrared radiation treatment is applied to dorsal, plantar, medial and lateral surface of the feet for twenty minutes and then, the passive electrode of tecar device is placed anterior surface of legs and its active electrode is moved along the tibial nerve pathway for twenty minutes in prone position. Control group: Patients in this group are treated with Infrared radiation (electromagnetic fields with 890 nanometers , 70-80 centimeters away from the surfaces of the foot) for 60 minutes and Sham Capacitive Tecar Therapy (electromagnetic fields with 300-800 Kilohertz and Zero intensity ) on Tibial nerve pathway with for 20 minutes in each session.Infrared radiation treatment is applied to dorsal, plantar, medial and lateral surface of the feet for twenty minutes and then, the passive electrode of tecar device is placed anterior surface of legs and its active electrode is moved along the tibial nerve pathway for twenty minutes in prone position; except that the current intensity is zero. Intensity of pain. Timepoint: Before treatment, after ten session, Follow up for six weeks. Method of measurement: Base on visual analogue scale. Tactile sensation of feet. Timepoint: Before treatment, After ten session, Follow up for six weeks. Method of measurement: Monofilament 5.07/10 g. Shahid Beheshti University of Medical Sciences Approved 2018-12-18 Ethics committee of Shahid Beheshti University of Medical Sciences 3th Floor, Medical school, Next to the Taleghani Hospital, Evin, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)