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IRCT20250621066210N1 IRCT 2026-01-04 Shahroud University of Medical Sciences The effect of transcutaneous electrical nerve stimulation at acupuncture points on hemodynamic indices and back pain in patients undergoing coronary artery catheterization The effect of transcutaneous electrical nerve stimulation at acupuncture points on hemodynamic indices and back pain in patients undergoing coronary artery catheterization: a randomized clinical trial 2025-12-31 anticipated 80 Complete https://irct.ir/trial/84553 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is used to assign individuals to groups. Randomization is performed by generating random numbers from 1 to 80 (80 is the total number of individuals in the control and intervention groups) and assigning each number to one of the groups. This is done based on the sequence obtained from the software. For example, person number one is placed in the control or intervention group, depending on which group the number 1 is assigned to. Also, during randomization, equal numbers of men and women are assigned to the two groups, Blinding description: The present study is triple-blind, meaning that the patients participating in the study are unaware of the type of group assigned (intervention and control). Also, the data collector and analyst will remain blind to the type of group assigned to the patients. Thus, the collection and recording of information including back pain, respiratory rate, pulse, oxygen saturation, and completion of the questionnaires will be done by a second person without knowing the group of individuals. N/A Condition 1: Presence of coronary angioplasty implant and graft. Condition 2: Backache. Intervention 1: Intervention group: Two 5x5 cm plastic electrodes are placed face to face or side by side at acupuncture points for pain relief (acupuncture points with the highest average effect size scores (GB30 and BL 40) connected to a BURJIS device, model ST90, manufactured in Iran and serial number ST90994090, and the burst mode and frequency will be set to 90 Hz and for a duration of 20 minutes. (The BL 40 point is located below the knee, and the GB30 point is located in the lower outer quarter of the gluteal muscle) and the pads will be attached to the leg opposite the angiography site (two small pads at each site, without the need to change the patient's position). Intervention 2: Control group: Two 5x5 cm plastic electrodes are attached at unrelated points (ST36, SP6, which have analgesic and anesthetic effects in the pelvic area and analgesia, respectively), and the burst mode and frequency will be set to 20 Hz (the lowest level) and for a duration of 20 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 No more information available.
public Abbas Asadi
No. 197, Forumandi 11 Ave., Forumandi Blvd.,Esfarayen
Esfarayen Iran (Islamic Republic of) 9661938944 +98 58 3723 9620 shahab.asadi92@gmail.com Shahroud University of Medical Sciences scientific Abbas Asadi
No. 197, Furomandi 11 Ave., Furomandi Blvd., esfarayen
esfarayen Iran (Islamic Republic of) 9661938944 +98 58 3723 9620 shahab.asadi92@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Candidate for coronary angiography Candidate for percutaneous coronary intervention via femoral artery Having full awareness and the power to communicate Presence of normal posterior tibia pulses Score higher than 3 for back pain using the NRS tool People 18 – 65 years old 18 years 65 years Both Use of antihypertensive medication before and during the study Use of painkillers before and during the study Presence of back pain/low back pain in the past week before catheterization Back pain/low back pain at first evaluation after catheterization Patients with stroke, psychosis, history of trauma or blows that have caused damage to the limbs and disrupted the patient's sensation and movement. Complications during angiography, such as hematoma, infection, bleeding, cardiac arrhythmias, and cardiac arrest Cardiac conduction disorders (may be affected by TENS electrical stimulation) History of allergies and skin sensitivity in the area where the electrodes are to be placed The presence of a skin lesion in the area where the electrodes are to be placed Psychological illnesses leading to patient non-cooperation History of TENS (due to familiarity with TENS and the possibility of affecting results) The need for oxygen to follow up on the patient's condition after angiography Z95.5 M54.9 Presence of coronary angioplasty implant and graft Dorsalgia, unspecified Treatment - Other Treatment - Other Intervention group: Two 5x5 cm plastic electrodes are placed face to face or side by side at acupuncture points for pain relief (acupuncture points with the highest average effect size scores (GB30 and BL 40) connected to a BURJIS device, model ST90, manufactured in Iran and serial number ST90994090, and the burst mode and frequency will be set to 90 Hz and for a duration of 20 minutes. (The BL 40 point is located below the knee, and the GB30 point is located in the lower outer quarter of the gluteal muscle) and the pads will be attached to the leg opposite the angiography site (two small pads at each site, without the need to change the patient's position). Control group: Two 5x5 cm plastic electrodes are attached at unrelated points (ST36, SP6, which have analgesic and anesthetic effects in the pelvic area and analgesia, respectively), and the burst mode and frequency will be set to 20 Hz (the lowest level) and for a duration of 20 minutes. Back pain • Score greater than 3 using the NRS tool. Timepoint: Before the intervention, 2, 4, and 6 hours after the intervention. Method of measurement: Numerical rating scale. Hemodynamic indicators. Timepoint: Before the intervention, 2, 4, and 6 hours after the intervention. Method of measurement: Intrusive bedside monitoring and assessment device. Shahroud University of Medical Sciences Approved 2025-09-08 Ethics Committee of Shahrood University of Medical Sciences Shahid Foromandi Street - Foromandi 12 اسفراین North Khorasan Iran (Islamic Republic of)