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IRCT20250408065257N1 IRCT 2025-05-12 Tehran University of Medical Sciences Effects of Central and Peripheral Stimulation Combined with Exercise in Women with Patellofemoral Pain Syndrome Synergistic Effects of transcranial Direct Current Stimulation, transcranial Alternative Current Stimulation and Neuromuscular Electrical Stimulation Combined with Exercise Therapy on Clinical Outcomes and Electroencephalographic Activity in Women with Patellofemoral Pain Syndrome 2025-05-22 anticipated 42 Recruiting https://irct.ir/trial/82781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All Eligible Patients will be Randomly Assigned Using Block Randomization with Blocks of Size 6, Equally Distributed into Three Groups (with an Allocation Ratio of 1:1:1): NMES+EX, tDCS+EX, and tACS+EX. The Group Allocation for Each Participant will be Concealed Using Sealed Envelopes, Blinding description: This study is double-blinded. Both participants and the outcome assessor will be blinded to the group allocation. All assessments will be performed by a physiotherapist who is independent of the research team and will only work with participant codes. In the tDCS and tACS groups, 20-minute brain stimulation is delivered prior to the exercise in a seated and relaxed position, using a constant intensity of 2 mA. Electrode placement is identical in both groups. The device interface and settings are indistinguishable, and the display screen is masked to prevent revealing the type of current. Participants are informed that the study involves different types of brain stimulation without specifying which type. In the NMES group, electrical stimulation is applied simultaneously with strengthening exercises, which makes complete blinding of participants in this group not feasible. However, the assessor remains blinded throughout and is not involved in any part of the intervention. 3 Patellofemoral Pain Syndrome. Intervention 1: Intervention group: NMES and Exercise Therapy. Intervention 2: Intervention group: tDCS and Exercise Therapy. Intervention 3: Intervention group: tACS and Exercise Therapy. 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 Individuals interested in receiving more information can contact the person responsible for the scientific correspondence of the study via email at karimpour-s@razi.tums.ac.ir.
public Samira Karimpour
No. 24 & 26, Rahmati Bahambari Ave., valiasr Sq.
Tehran Iran (Islamic Republic of) 1594733711 +98 21 7753 3939 karimpour-s@razi.tums.ac.ir Tehran University of Medical Sciences scientific Samira Karimpour
No. 24 & 26, Rahmati Bahambari Ave., valiasr Sq.
Tehran Iran (Islamic Republic of) 1594733711 +98 21 7753 3939 karimpour-s@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women Aged Between 18 and 35 Years History of Unilateral or Bilateral Pain Around or Behind the Patella, Exacerbated by at Least Two of the Following Activities: Squatting, Going Up or Down Stairs, or Prolonged Sitting with Knees Bent Tenderness to Palpation Over the Medial or Lateral Facets of the Patella Pain During Isometric Contraction of the Quadriceps Against Resistance Applied Above the Patella, and Pain During Resisted Knee Extension at Various Degrees of Flexion Non-traumatic Onset of Symptoms Patellofemoral Joint Pain for at Least the Past 3 Months Minimum Literacy Level Equivalent to Completion of Middle School 18 years 35 years Female History of Knee Injuries such as Meniscal, Tendon, or Ligament Damage History of Patellar Subluxation or Dislocation Any Condition Affecting Other Joints Involving the Lower Limbs or the Back History of Fractures in the Spine or Lower Limbs History of Surgery or Arthroscopy in any of the Lower Limb Joints History of Head Trauma, Neurological Disorders, or Mental Health Issues Contraindications for Neuromodulation such as Pregnancy, Presence of Metal Implants, Epilepsy, History of Skull Fracture, or Cardiac Pacemaker Rehabilitation Rehabilitation Rehabilitation Intervention group: NMES and Exercise Therapy Intervention group: tDCS and Exercise Therapy Intervention group: tACS and Exercise Therapy Pain Intensity on Visual Analogue Scale. Timepoint: Pain intensity will be measured at the beginning of the study (before the start of the intervention), after completing 12 intervention sessions, and one month after the end of the intervention. Method of measurement: Visual Analogue Scale. Functional Activity Level. Timepoint: Functional Activity Level will be measured at the beginning of the study (before the start of the intervention), after completing 12 intervention sessions, and one month after the end of the intervention. Method of measurement: Kujala Questionnaire. Dynamic Balance. Timepoint: Dynamic Balance will be measured at the beginning of the study (before the start of the intervention), after completing 12 intervention sessions, and one month after the end of the intervention. Method of measurement: Y-balance test. Functional Performance. Timepoint: Functional Performance will be measured at the beginning of the study (before the start of the intervention), after completing 12 intervention sessions, and one month after the end of the intervention. Method of measurement: Step-Down test. Mean relative power of the EEG frequency bands. Timepoint: Mean relative power of the EEG frequency bands will be measured at the beginning of the study (before the start of the intervention), after completing 12 intervention sessions, and one month after the end of the intervention. Method of measurement: Recording with an EEG device and measurement using sLORETA software. Mean absolute power of the EEG frequency bands. Timepoint: Mean absolute power of the EEG frequency bands will be measured at the beginning of the study (before the start of the intervention), after completing 12 intervention sessions, and one month after the end of the intervention. Method of measurement: Recording with an EEG device and measurement using sLORETA software. Tehran University of Medical Sciences Approved 2025-04-24 Ethics committee of Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)