Comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis

Aim is comparison of tDCS and Sham tDCS for reduction of pain in patients with knee osteoarthritis attending to Imam-Reza Hospital in 2019-2020

Clinical trial with a control group with parallel groups, single-blind, randomized.

This study was conducted as a clinical trial in Imam Reza Hospital and in patients with knee osteoarthritis, this is a single-blind study in which patients will blinded. This is in phase 4 and in this 54 patients with a block method are divided into two groups, 27 patients in first intervention group and receive tDCS, and 27 patients in second intervention group receiving Sham tDCS. Based on this, at first and three month after starting treatment, pain of patients will assessed.

Patients with knee osteoarthritis, age between 20 to 70 years, pain over 6 months, VAS between 3 and 7 and Being able to express the intensity of pain will included in study, also patents with a metal or device in the head, carbamazepine use in the last 6 months, drug addiction, alcohol consumption in the last 6 months, history of neurological diseases, history of neurosurgery and a history of severe depression will excluded from study.

In first group, stimulation will performed using transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 20 minutes, and in another stimulation will performed using Sham transcranial direct current stimulation (tDCS) for 5 sessions and for 5 consecutive days using a 35 cm 2 electrode with a current of 2 mA, each stimulation was performed for 30 seconds.

Pain of Knee Osteoarthritis

The dates had been erroneously typed. Blinding statement had been written in the section Randomization. The randomization protocol had been written as "simple" (Now, it has been corrected into "block") We consider a placebo-sham control group in our study.

We use block randomization to ensure that the two groups are of the same size. Patients are randomized by blocked randomization of size two or four to the two groups of active or sham tDCS. Random numbers are generated in an independent statistical room using a computer. The units of randomization are individuals. There is no stratification in the randomization process.

Our study is a single-blind randomized trial. The participants will be unaware of the sham or active treatment they would receive throughout the study. The investigators and clinicians are not masked to the patients' group assignment.