]>
IRCT20190108042292N4 IRCT 2022-11-29 Semnan University of Medical Sciences The effect of radial extracorporeal shock wave therapy on Peyronie’s disease ESWT(extracorporeal shock wave therapy) Comparing the effect of radial extracorporeal shock wave with and without manual penile stretching on Peyronie’s disease: A randomized clinical trial 2023-02-20 anticipated 30 Complete https://irct.ir/trial/67034 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Thirty patients participating in this study are placed randomly in two groups. With 15 patients in intervention group who are treated with extracorporeal shock waves in the stretched position of the penis and 15 patients in control group who are treated with radial extracorporeal shock wave treatment in the resting or flaccid state of the penis, six sessions, 2 times a week, Randomization description: The sample size in each group is 15 people (30 people in total). Permuted block randomization method will be used for randomization. In this regard, blocks of four with numbers 1 to 6 will be used as follows: (in each block, a means the intervention group and b means the control group): 1-aabb 2-abba 3-abab 4-baba 5-baab 6-bbaa After choosing numbers one to six from the table of random numbers (numbers 0 and 7 to 9 are not taken into account), the block associated with each number is determined and the eligible people are enrolled in the study from left to right in each block and will be assigned in one of a or b group. The numbers will be selected seven times and the first 28 people will be grouped in this way, and the last two people will be entered into the group by assigning a coin. Participants, therapists, and evaluators will be unaware of the grouping. To implement the generated random sequence, the method of hiding the box or coded cans is used. In this method, the cans will be numbered based on a random sequence, and inside the boxes, the desired intervention will be given to the therapist with a sheet on which the random allocation is written, with the condition that the boxes are completely sealedو and the therapist will assign patients to intervention and control groups based on the order of arrival, Blinding description: A physiotherapist will be in charge of the treatment process of the intervention group, and another physiotherapist and a radiologist will evaluate the desired variables. Therefore, the future study will be a single-blind study. N/A Peyronie's disease. Intervention 1: Intervention group: The treatment in the intervention group (15 people) will include radial extracorporeal shock wave treatment and manual stretching simultaneously, the skin covering the plaque is locally anesthetized with lidocaine spray. The therapist stretches the head of the penis between the two fingers of one hand to the maximum amount tolerated by the patient and with the other hand applies mechanical pressure to the concavity of the body of the penis. Mechanical pressure of 4 bar with the frequency of 8 Hz and 3000 strokes is given in six sessions and twice a week. Intervention 2: Control group: The control group (15 people) will receive the radial extracorporeal shock wave treatment in the resting or flaccid state of the penis flaccid with the above method. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Cyrus Taghizadeh Delkhoush
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 cyrustaghizadeh@yahoo.com Semnan University of Medical Sciences scientific Dr. Cyrus Taghizadeh Delkhoush
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 cyrustaghizadeh@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Age range older than 18 years old Pain less than 7 in resting and erection according to VAS Men with full erection 18 years no limit Male Drug treatment in three weeks before the intervention Inability to tolerate pain during radial extracorporeal shock wave treatment Any surgery or disease in the urinary-genital tract Psychiatric diseases or psychogenic erectile dysfunction Neurological disease and lumbar sacral peripheral nerve damage Penile abnormalities. N48.6 Peyronie disease, Plastic induration of penis Treatment - Devices Treatment - Devices Intervention group: The treatment in the intervention group (15 people) will include radial extracorporeal shock wave treatment and manual stretching simultaneously, the skin covering the plaque is locally anesthetized with lidocaine spray. The therapist stretches the head of the penis between the two fingers of one hand to the maximum amount tolerated by the patient and with the other hand applies mechanical pressure to the concavity of the body of the penis. Mechanical pressure of 4 bar with the frequency of 8 Hz and 3000 strokes is given in six sessions and twice a week Control group: The control group (15 people) will receive the radial extracorporeal shock wave treatment in the resting or flaccid state of the penis flaccid with the above method Penile plaque dimensions. Timepoint: Before and After the Intervention and one month follow up. Method of measurement: Size of the penile plaque (length, width, circumference, and surface of the plaque) with ultrasonography will be measured. Sexual function, pain, length and angle of penis. Timepoint: Before and After the intervention and one month follow up. Method of measurement: Sexual function with International index of erectile function questionnaire-5 , pain with visual analogue scale, length of the penis with photography and ruler, angle of penile deviation with photography and goniometer will be measured. Semnan University of Medical Sciences Approved 2022-10-24 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services Basj Blvd, Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)