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IRCT20131225015932N18 IRCT 2023-02-10 Shiraz University of Medical Sciences The evaluation of the priming effect of transcranial direct current stimulation over primary motor cortex and primary somatosensory cortex on the effect of exercise training on pain, function, balance, kinesiophobia and quality of life in patients with knee osteoarthritis-a randomized controlled trial The evaluation of the priming effect of transcranial direct current stimulation over primary motor cortex and primary somatosensory cortex on the effect of exercise training on pain, function, balance , kinesiophobia and quality of life in patients with knee osteoarthritis-a randomized controlled trial 2023-04-04 anticipated 45 Complete https://irct.ir/trial/67931 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: The randomization list was prepared with the Random Allocation software, based on the permuted block randomization method in which the block size was 3 and the number of blocks was 15, Blinding description: The researcher who assigns the volunteers to different groups based on the random list is different from the researcher who performs the treatment and another researcher will also analyze the data. N/A Knee osteoarthritis. Intervention 1: Control group: Exercise therapy and placebo tDCS. Intervention 2: Intervention group: Exercise therapy and anodal tDCS on M1. Intervention 3: Intervention group: Exercise therapy and cathodal tDCS on S1. 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 I haven't decided yet
public Amin Rastgar sangari
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 3366971947 00 71 3336 1081 rastgar.amin@yahoo.com Shiraz University of Medical Sciences scientific Dr. Alireza Motealleh
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 3366971947 +98 71 3336 1081 motealleh@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of osteoarthritis in one or both knees by an orthopedic specialist for these patients (having at least three of the six criteria of the American College of Rheumatology, including age over 50 years, morning stiffness less than half an hour, tenderness in bone margins, crepitus in active joint movements, bone enlargement and no palpable increase in temperature People aged 50 to 70 who are willing and eager to enter the study and can cooperate in various stages of evaluation, treatment and follow-up Grade two or three of diseases in the knee osteoarthritis classification system (Kllgren and Lawrence system classification) according to a radiograph that was taken at most one year ago minimum pain intensity of four out of ten (while walking in the last week) in Visual analogue scale of pain. 50 years 70 years Both Traumatic knee injuries Acute joint inflammation Rheumatology diseases such as Rheumatoid arthritis, lupus erythematosus and Fibromyalgia, Neurological diseases that affect the function of the lower limbs, such as stroke, Parkinson's disease, MS, peripheral neuropathy and a history of seizures or their occurrence, severe headaches after the first session of receiving the electrical current, mental and cognitive problems (Mini-Mental Status Exam score ≤ 23),Cardiovascular problems such as high blood pressure or heart attack History of surgery (such as joint replacement or tibial osteotomy) in one or both knees, history of head surgery, Brain tumor or metal implant in the head, history of lower limb surgery in the last six months Inability to walk without an assistive device, receiving treatment or rehabilitation services for knee osteoarthritis in the last three months Taking drugs that affect the central nervous system such as dextromethorphan and D-cycloserine in the last six months Drug or alcohol abuse Being hospitalized for the past year due to mental illnesses M17 Osteoarthritis of knee Placebo Treatment - Devices Treatment - Devices Control group: Exercise therapy and placebo tDCS Intervention group: Exercise therapy and anodal tDCS on M1 Intervention group: Exercise therapy and cathodal tDCS on S1 Pain. Timepoint: Before treatment, third week of treatment, fourth week of treatment and one month after treatment. Method of measurement: Visual analogue scale. Balance. Timepoint: Before treatment, third week of treatment, fourth week of treatment and one month after treatment. Method of measurement: Modified star excursion balance test. Quality of life. Timepoint: Before treatment, third week of treatment, fourth week of treatment and one month after treatment. Method of measurement: SF36 questionnaire. Kinesiophobia. Timepoint: Before treatment, third week of treatment, fourth week of treatment and one month after treatment. Method of measurement: Tampa scale. Function. Timepoint: Before treatment, third week of treatment, fourth week of treatment and one month after treatment. Method of measurement: WOMAC. Shiraz University of Medical Sciences Approved 2023-01-30 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences Building, Zand Street,shiraz. Shiraz Fars Iran (Islamic Republic of)