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IRCT20220216054035N2 IRCT 2025-08-05 Shahid Beheshti University of Medical Sciences The effects of active and passive mobilization of tibial nerve in neuropathy of type 2 diabetic patients Comparing the effects of active and passive mobilization of tibial nerve on pain intensity and conduction velocity of tibial nerve in neuropathy of type 2 diabetic patients 2025-09-03 anticipated 30 Recruiting https://irct.ir/trial/80725 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the simple individual randomization method, patients who meet the study entry criteria after evaluation randomly select one of two types of sealed envelopes, corresponding to the active or passive mobilization method, and thus their type of intervention group is determined, Blinding description: Participants are unaware of which treatment group they will be placed in. Participants in two different groups will be treated at different times so that they do not realize the differences in the treatments through observation and conversation with each other. N/A Neuropathy of diabetes. Intervention 1: Intervention group 1: Active mobilization of tibial nerve is performed five sessions per week for 3 weeks in supervised manner. To perform the neurodynamic gliding exercise of the tibial nerve: The patient sits in a slump position. In the starting position, the neck, trunk, and knee are in flexion, the ankle is in plantar flexion and inversion, that brings the neck, trunk, and knee into extension and the ankle into dorsiflexion and eversion. This cycle lasts 4 seconds each time and we ask the patient to repeat this 10 times sitting on the bed. Intervention 2: Intervention group 2: passive mobilization of tibial nerve with the patient in the supine position five sessions per week for 3 weeks. Tibial nerve glide The patient is in the supine position, in the starting position the patient's knee is in extension and the ankle is in plantarflexion and inversion, and the therapist moves the ankle to dorsiflexion and eversion and the knee to flexion.Tibial nerve tension with the shock lock method: The patient is in the supine position, in the starting position the patient's knee is in flexion and the ankle is in plantarflexion and inversion, and the therapist moves the ankle to dorsiflexion and eversion and the knee to extension. This method is performed 10 times for the patient in each session. Yes - There is a plan to make this available What will be shared: Pain intensity When: Six months after publication of the paper To whom: All people Conditions: People that research in this field Where to obtain: Via email: monireaalem@gmail.com How to obtain: Send a request via email and state for what purpose he/she need the data. Comments:
public Monire Alem
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali hospital, Damavand Street
Tehran Iran (Islamic Republic of) 1985713871 +98 21 7754 2057 monireaalem@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyyed Majid Hossaini
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali hospital, Damavand Street
Tehran Iran (Islamic Republic of) 1985713871 +98 21 7754 2057 majidhosseini44@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Passing at least 2 years since the onset of diabetes Their leg pain is 3 or higher Their blood sugar levels are in the range of 100-250 It has been 6 months since the onset of neuropathy symptoms Men and women with type 2 diabetes In the age group of 40-75 years Grade 1 and 2 neuropathy via monofilament instrument, Michigan questionnaire, and tibial nerve conduction velocity assessment 40 years 75 years Both Diabetic foot ulcer Irritable pain Lumbar disc herniation Damage to the nerves of the lower extremities History of cardiovascular disease Musculoskeletal deformity Lack of cooperation or understanding during sensory testing or manual therapy Dependency to drug or alcohol Lumbar disc herniation Damage to the nerves of the lower extremities Retinopathy History of cardiovascular disease E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified Rehabilitation Treatment - Other Intervention group 1: Active mobilization of tibial nerve is performed five sessions per week for 3 weeks in supervised manner. To perform the neurodynamic gliding exercise of the tibial nerve: The patient sits in a slump position. In the starting position, the neck, trunk, and knee are in flexion, the ankle is in plantar flexion and inversion, that brings the neck, trunk, and knee into extension and the ankle into dorsiflexion and eversion. This cycle lasts 4 seconds each time and we ask the patient to repeat this 10 times sitting on the bed. Intervention group 2: passive mobilization of tibial nerve with the patient in the supine position five sessions per week for 3 weeks. Tibial nerve glide The patient is in the supine position, in the starting position the patient's knee is in extension and the ankle is in plantarflexion and inversion, and the therapist moves the ankle to dorsiflexion and eversion and the knee to flexion.Tibial nerve tension with the shock lock method: The patient is in the supine position, in the starting position the patient's knee is in flexion and the ankle is in plantarflexion and inversion, and the therapist moves the ankle to dorsiflexion and eversion and the knee to extension. This method is performed 10 times for the patient in each session. Conduction velocity of tibial nerve. Timepoint: Before intervention and end of treatment sessions (19th day). Method of measurement: Electromyography. Pain. Timepoint: Before intervention and end of treatment sessions (19th day). Method of measurement: Visual analog scale (VAS). Neuropathy score on the Michigan Questionnaire. Timepoint: Before intervention and end of treatment sessions (19th day). Method of measurement: With Michigan questionnaire, this questionnaire consists of two parts: Part A,ranging from 0 to a score of 13, with a higher score indicating greater severity of neuropathy , and Part B, where a score above 2 indicates neuropathy. Quality of life questionnaire score. Timepoint: Before intervention and end of treatment sessions (19th day). Method of measurement: Quality of life Questionnaire with 15 questions. Leg raising range of motion. Timepoint: Before intervention and end of treatment sessions (19th day). Method of measurement: Goniometer. Shahid Beheshti University of Medical Sciences Approved 2024-12-14 Ethics committee of Shahid Beheshti University of Medical Sciences No. 8, Shams Alley, before Tavanir, Valiasr Street, Tehran Tehran Tehran Iran (Islamic Republic of)