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IRCT20131225015932N17 IRCT 2022-10-29 Shiraz University of Medical Sciences Comparison of the effects of transcranial direct current stimulation (tDCS) plus exercise with exercise alone on pain, function and balance in individuals with patellofemoral pain Comparison of the effects of transcranial direct current stimulation (tDCS) plus exercise with exercise alone on pain, function and balance in individuals with patellofemoral pain 2022-12-01 anticipated 24 Complete https://irct.ir/trial/65921 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, according to previous related studies, the necessary sample size of 20 subjects (10 subjects in each group) will be considered, and considering 20% dropout and a 1:1 ratio (intervention: control), at least 12 subjects will be considered for each group. Allocation of participants to groups will be based on the block randomization method. One month after interventions both groups will be evaluated for follow-up, Randomization description: Allocation of patients into 2 intervention and control groups is done by the block randomization method. The allocation sequence is generated using the free web system at http://www.randomization.com. Opaque and sealed envelopes will be used to hide the allocation of patients to groups, Blinding description: The physiotherapist who will measure the outcome measures and the physiotherapist who will analyze the outcome measures will be blinded to the patient’s allocation group. N/A Patellofemoral pain. Intervention 1: Intervention group: real tDCS plus knee, hip, and trunk strengthening exercises: In this group, the participants will receive 20 minutes of real tDCS for one month and 3 sessions per week, with the method of placing the anode on the CZ and the cathode on the middle of the forehead with a current of 2 mA and then they will do stretching exercises for quadriceps, hamstrings, iliotibial band, and calf muscles (3 repetitions, 30-second hold) and knee and hip and trunk strengthening exercises including quadriceps setting, terminal knee extension, straight leg raise, and hip abductor and external rotator, and Transversus abdominis and multifidus muscle training: Quadruped and prone with 10-second isometric contraction in the first and second week and 15 seconds in 3rd and 4th week, Sitting on the Swiss ball: with 20-second isometric contraction in the first and second week and 25 seconds in 3rd and 4th week, ventral bridge and lateral bridge with 30 seconds hold in the first and second week and 35 seconds hold in 3rd and 4th week. Each session almost will take time 60 minutes. Intervention 2: Control group: sham tDCS plus knee, hip, and trunk strengthening exercises: In this group, the participants will receive 20 minutes of sham tDCS for one month and 3 sessions per week, with the method of placing the anode on the CZ and the cathode on the middle of the forehead (but the current is only on for 10 seconds and then it is cut off). And then they will do stretching exercises for quadriceps, hamstring, iliotibial band, and calf muscles (3 repetitions, 30-second hold) and knee and hip and trunk strengthening exercises including quadriceps setting, terminal knee extension, straight leg raise, and hip abductor and external rotator, and Transversus abdominis and multifidus muscle training: Quadruped and prone with 10-second isometric contraction in the first and second week and 15 seconds in 3rd and 4th week, Sitting on the Swiss ball: with 20-second isometric contraction in the first and second week and 25 seconds in 3rd and 4th week, ventral bridge and lateral bridge with 30 seconds hold in the first and second week and 35 seconds hold in 3rd and 4th week. Each session almost will take time 60 minutes. 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 Zahra Mohtashamzade
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
Shiraz Iran (Islamic Republic of) 3366971947 +98 71 3336 1081 z.mohtashamzade@gmail.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) Women and men aged 18-40 years/old with unilateral patellofemoral pain Anterior knee pain provoked by at least 2 of the following activities: prolonged sitting, ascending or descending stairs, squatting, kneeling, jumping, running Pain on palpation of the medial and lateral patellar facets, and positive Clarke's sign Insidious onset of symptoms without a history of trauma and injury Average pain level of at least 3 out of 10 on VAS during the previous week in activities of daily living (ADL) Kujula scores 50-80 The presence of pain for at least 3 months 18 years 40 years Both Other knee joint pathologies such as meniscus and ligament injuries, osteoarthritis and tendon impairments; Self-reported history of patellar subluxation or dislocations; plica syndrome and Osgood-Schlatter disease; trauma in hip; knee or ankle joint Previous knee surgery Radicular pain from other joints including lumbar spine, hip and sacroiliac joints Metabolic disorders such as Diabetes; neurological, and rheumatology diseases such as Stroke; MS; RA and balance disorders and peripheral Neuropathies Professional athletes who participates in a specific sport at least 2 h /day and 3 times a week regularly Pregnancy Heart diseases Consumption of alcohol and drugs that affect the central nervous system and balance such as Dextromethorphan and D_cycloserine Diseases that interfere with tDCS, such as history of epilepsy, history of brain surgery, brain tumor, brain implants Cognitive disorders due to the consumption of alcohol and drugs in the last six months Uncorrected vision and hearing impairment M22.2 Patellofemoral disorders Rehabilitation Rehabilitation Intervention group: real tDCS plus knee, hip, and trunk strengthening exercises: In this group, the participants will receive 20 minutes of real tDCS for one month and 3 sessions per week, with the method of placing the anode on the CZ and the cathode on the middle of the forehead with a current of 2 mA and then they will do stretching exercises for quadriceps, hamstrings, iliotibial band, and calf muscles (3 repetitions, 30-second hold) and knee and hip and trunk strengthening exercises including quadriceps setting, terminal knee extension, straight leg raise, and hip abductor and external rotator, and Transversus abdominis and multifidus muscle training: Quadruped and prone with 10-second isometric contraction in the first and second week and 15 seconds in 3rd and 4th week, Sitting on the Swiss ball: with 20-second isometric contraction in the first and second week and 25 seconds in 3rd and 4th week, ventral bridge and lateral bridge with 30 seconds hold in the first and second week and 35 seconds hold in 3rd and 4th week. Each session almost will take time 60 minutes. Control group: sham tDCS plus knee, hip, and trunk strengthening exercises: In this group, the participants will receive 20 minutes of sham tDCS for one month and 3 sessions per week, with the method of placing the anode on the CZ and the cathode on the middle of the forehead (but the current is only on for 10 seconds and then it is cut off). And then they will do stretching exercises for quadriceps, hamstring, iliotibial band, and calf muscles (3 repetitions, 30-second hold) and knee and hip and trunk strengthening exercises including quadriceps setting, terminal knee extension, straight leg raise, and hip abductor and external rotator, and Transversus abdominis and multifidus muscle training: Quadruped and prone with 10-second isometric contraction in the first and second week and 15 seconds in 3rd and 4th week, Sitting on the Swiss ball: with 20-second isometric contraction in the first and second week and 25 seconds in 3rd and 4th week, ventral bridge and lateral bridge with 30 seconds hold in the first and second week and 35 seconds hold in 3rd and 4th week. Each session almost will take time 60 minutes. Pain intensity. Timepoint: First,12th session and 1 month after interventions. Method of measurement: Visual Analogue Scale (VAS). Function. Timepoint: First, 12th session, and 1 month after interventions. Method of measurement: Kujala questioner. Function. Timepoint: First, 12th session, and 1 month after interventions. Method of measurement: Step down test. Static balance. Timepoint: First,12th session and 1 month after interventions. Method of measurement: Single leg stance balance test. Dynamic balance. Timepoint: First,12th session and 1 month after interventions. Method of measurement: Modified star excursion balance test. Shiraz University of Medical Sciences Approved 2022-09-16 Ethics committee of Shiraz University of Medical Sciences Rehabilitation school of Shiraz University of Medical Sciences, Abivardi Ave., Chamran Boulevard shiraz Fars Iran (Islamic Republic of)