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IRCT20260629070006N1 IRCT 2026-08-25 Razi University, Kermanshah The effects of transcranial electrical brain stimulation on pain, balance, and motor function in female students with anterior knee pain Comparison of The Effects of Single-Site and Concurrent Transcranial Direct Current Stimulation (M1, DLPFC) on Pain Intensity, Balance, Motor Function and Quadriceps Muscle Strength in Female Students with Patellofemoral Pain Syndrome 2026-08-23 anticipated 42 Recruiting https://irct.ir/trial/91872 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants were randomly allocated using simple randomization to three groups of 14 participants each: Experimental Group 1 (receiving transcranial direct current stimulation [tDCS] over the primary motor cortex), Experimental Group 2 (receiving simultaneous tDCS over the primary motor cortex and dorsolateral prefrontal cortex), and the sham group (receiving sham stimulation without an actual therapeutic effect). The random allocation sequence was generated using the Random Allocation Software by an independent individual who was not involved in the study. For allocation concealment, a random code was assigned to each allocation, and the codes generated from the randomization sequence were placed separately in opaque, sealed envelopes. After each eligible participant entered the study, the envelopes were made available to the participant, who randomly selected one envelope. After opening the envelope, the code inside was matched with the randomization list, and the participant’s assigned group was determined. Thus, the participant’s selection of an envelope resulted in random allocation to one of the three groups, and group assignment could not be predicted or observed before the envelope was selected. The unit of randomization was the individual participant, and no block, stratified, or cluster randomization was used, Blinding description: Outcome assessors and participants were blinded to the type of intervention administered. Prior to the commencement of the study, to ensure allocation concealment, the codes generated from the random allocation sequence by an independent individual who was not involved in the study, using the Random Allocation Software, were placed separately in opaque, sealed envelopes. After each eligible participant entered the study, the participant randomly selected one of the envelopes. After opening the envelope, the code inside was matched with the randomization list, and the participant’s assigned group was determined. Thus, group allocation could not be observed or predicted by the participant or the outcome assessor before the envelope was selected and opened. The interventions across the study groups were similar in terms of administration procedure, number and duration of sessions, and conditions of stimulation, with the only difference being the stimulation site in the active intervention groups. In the sham group, sham stimulation was administered using the same procedure. Therefore, participants were unaware of the type of intervention they received and their group allocation. Since participants were also unaware of the type of intervention administered to the other groups, they could not determine which group they had been assigned to. N/A Patellofemoral Pain Syndrome. Intervention 1: Intervention group: Transcranial Direct Current Stimulation Over the Primary Motor Cortex Participants in this group received transcranial direct current stimulation (tDCS) targeting the primary motor cortex. The intervention was administered using a Nerostim2 device manufactured by Medina Teb Gostar, Tehran, Iran, at a current intensity of 2 mA for 20 minutes per session. A total of 6 sessions were conducted, with 3 sessions per week over a period of 2 weeks. The international 10–20 brain mapping system and a dedicated electroencephalography cap were used to determine the precise electrode placement. Sponge electrodes soaked in saline solution were placed over the pre-marked areas. In participants with predominant symptoms in the right knee, the 4 × 5 cm anode was placed over the C3 location, whereas in participants with predominant symptoms in the left knee, the anode was placed over the C4 location. The 4 × 9 cm cathode was placed over the upper region of the contralateral orbit. Intervention 2: Intervention group: Simultaneous Transcranial Direct Current Stimulation Over the Primary Motor Cortex and Dorsolateral Prefrontal Cortex Participants in this group received transcranial direct current stimulation (tDCS) targeting the primary motor cortex and dorsolateral prefrontal cortex simultaneously. The intervention was administered using a Nerostim2 device manufactured by Medina Teb Gostar, Tehran, Iran, at a current intensity of 2 mA for 20 minutes per session. The intervention consisted of a total of 6 sessions, with 3 sessions per week over a period of 2 weeks. The international 10–20 brain mapping system and a dedicated electroencephalography cap were used to determine the electrode placement. Sponge electrodes soaked in saline solution were placed over the marked areas. In this group, two 4 × 5 cm anodes were placed at the F3 and Cz locations. Two 4 × 9 cm cathodes were placed at AF8 and between AFz and FPz, respectively. Intervention 3: Control group: Sham Transcranial Direct Current Stimulation Participants in the control group received sham transcranial direct current stimulation (sham tDCS). The intervention was administered using a Nerostim2 device manufactured by Medina Teb Gostar, Tehran, Iran. To maintain conditions comparable to those of the intervention groups, participants underwent a total of 6 stimulation sessions, with 3 sessions per week over a period of 2 weeks. Each session lasted 20 minutes.The international 10–20 brain mapping system and a dedicated electroencephalography cap were used to determine the electrode placement. Sponge electrodes soaked in saline solution were placed over the designated areas. In the control group, the electrode placement procedure and session conditions were similar to those of the intervention groups. However, in the sham stimulation condition, the electrical current was gradually increased over a period of 30 seconds to mimic the sensation associated with anodal stimulation, after which the current was discontinued and returned to the initial state. Thus, no effective electrical stimulation was delivered to the target areas. No - There is not a plan to make this available Justification or reason for not sharing IPD is To protect the confidentiality and privacy of participants’ information and due to restrictions on sharing individual-level data, the raw and individual participant data will not be made publicly available. The overall study results will be reported in an aggregated form, without any possibility of identifying individual participants.
public Morvarid Ahmadi
Second Taleghani Street, Arabi Intersection, right-hand side, the first cream-colored apartment building, first floor.
Sari Iran (Islamic Republic of) 4818959820 +98 11 3328 5108 ahmadimorvarid177@gmail.com Razi University, Kermanshah, Iran scientific Farzaneh Gandomi
Razi University, University Street, Taq-e Bostan, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7605 gandomi777@gmail.com Razi University, Kermanshah Iran (Islamic Republic of) Sex: Female Age range: 18–35 years The presence of knee valgus, as assessed by the Forward Step-Down Test Unilateral knee pain A minimum pain score of 3 on the Visual Analog Scale (VAS) Anterior knee pain elicited during at least three of the following: prolonged sitting, stair ascent or descent, squatting, palpation of the patellar facets, bilateral squat, or a positive Clarke's test 18 years 35 years Female History of knee injury or surgery involving the ligaments, menisci, or other knee structures. Participants with knee pathologies such as knee osteoarthritis, patellar tendinopathy, meniscal lesions, osteochondral lesions, or ligament injuries. Traumatic or recurrent patellar dislocation Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within the past week Pregnancy Psychiatric disorders Previous treatment within the past 6 months Treatment - Devices Treatment - Devices Other Intervention group: Transcranial Direct Current Stimulation Over the Primary Motor Cortex Participants in this group received transcranial direct current stimulation (tDCS) targeting the primary motor cortex. The intervention was administered using a Nerostim2 device manufactured by Medina Teb Gostar, Tehran, Iran, at a current intensity of 2 mA for 20 minutes per session. A total of 6 sessions were conducted, with 3 sessions per week over a period of 2 weeks. The international 10–20 brain mapping system and a dedicated electroencephalography cap were used to determine the precise electrode placement. Sponge electrodes soaked in saline solution were placed over the pre-marked areas. In participants with predominant symptoms in the right knee, the 4 × 5 cm anode was placed over the C3 location, whereas in participants with predominant symptoms in the left knee, the anode was placed over the C4 location. The 4 × 9 cm cathode was placed over the upper region of the contralateral orbit. Intervention group: Simultaneous Transcranial Direct Current Stimulation Over the Primary Motor Cortex and Dorsolateral Prefrontal Cortex Participants in this group received transcranial direct current stimulation (tDCS) targeting the primary motor cortex and dorsolateral prefrontal cortex simultaneously. The intervention was administered using a Nerostim2 device manufactured by Medina Teb Gostar, Tehran, Iran, at a current intensity of 2 mA for 20 minutes per session. The intervention consisted of a total of 6 sessions, with 3 sessions per week over a period of 2 weeks. The international 10–20 brain mapping system and a dedicated electroencephalography cap were used to determine the electrode placement. Sponge electrodes soaked in saline solution were placed over the marked areas. In this group, two 4 × 5 cm anodes were placed at the F3 and Cz locations. Two 4 × 9 cm cathodes were placed at AF8 and between AFz and FPz, respectively. Control group: Sham Transcranial Direct Current Stimulation Participants in the control group received sham transcranial direct current stimulation (sham tDCS). The intervention was administered using a Nerostim2 device manufactured by Medina Teb Gostar, Tehran, Iran. To maintain conditions comparable to those of the intervention groups, participants underwent a total of 6 stimulation sessions, with 3 sessions per week over a period of 2 weeks. Each session lasted 20 minutes.The international 10–20 brain mapping system and a dedicated electroencephalography cap were used to determine the electrode placement. Sponge electrodes soaked in saline solution were placed over the designated areas. In the control group, the electrode placement procedure and session conditions were similar to those of the intervention groups. However, in the sham stimulation condition, the electrical current was gradually increased over a period of 30 seconds to mimic the sensation associated with anodal stimulation, after which the current was discontinued and returned to the initial state. Thus, no effective electrical stimulation was delivered to the target areas. Pain intensity. Timepoint: Before the intervention (pre-intervention) and after completion of the intervention (post-intervention). Method of measurement: Pain intensity will be measured using the Visual Analog Scale (VAS). Static balance. Timepoint: Before the intervention (pre-intervention) and after completion of the intervention (post-intervention). Method of measurement: Static balance will be assessed using the TECNOBODY Prokin 252 balance system (Italy), located at the Exercise Physiology Laboratory, Faculty of Sport Sciences, Razi University. Dynamic balance. Timepoint: Before the intervention (pre-intervention) and after completion of the intervention (post-intervention). Method of measurement: Dynamic balance will be assessed using the Y-Balance Test (YBT). Forward Step-Down Test score. Timepoint: Before the intervention (pre-intervention) and after completion of the intervention (post-intervention). Method of measurement: The Forward Step-Down Test score will be assessed using the Forward Step-Down Test. During the test, participants will stand on a 20-cm step with their arms crossed over their chest. They will then be instructed to step forward toward the floor while maintaining balance on the weight-bearing limb. After the heel of the non-weight-bearing foot makes initial contact with the floor, they will return to the starting position. Motor function. Timepoint: Before the intervention (pre-intervention) and after completion of the intervention (post-intervention). Method of measurement: Motor function will be assessed using the Anterior Knee Pain Scale (AKPS), also known as the Kujala Questionnaire. This questionnaire evaluates patients' self-reported symptoms and functional limitations related to patellofemoral pain syndrome. It consists of 13 items assessing knee function during daily activities. Quadriceps muscle strength. Timepoint: Before the intervention (pre-intervention) and after completion of the intervention (post-intervention). Method of measurement: Quadriceps muscle strength will be assessed using a hand-held dynamometer. Razi University, Kermanshah Approved 2026-07-01 Research Ethics Committee of Razi University, Kermanshah Faculty of Sport Sciences, Razi University Campus, Baghe Abrisham, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)