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IRCT20230103057034N1 IRCT 2023-05-02 Arak University of Medical Sciences Effects of transcutaneous electrical nerve stimulation (TENS) on pain due fracture Effects of transcutaneous electrical nerve stimulation (TENS) on reduction pain feeling after hip and proximal of femoral fractures surgury 2022-04-03 anticipated 74 Complete https://irct.ir/trial/67820 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sampling will be available. Then, the examined samples in this study are placed in the investigated groups (control and TENS intervention) using random allocation of patients. Two-group randomization on the web (www.graphpad.com) is used to create a simple random sequence. Enter the number of the sample size (74) on the website and the software randomly divided the numbers 1 to 74 into two equal groups A and B, and we considered the numbers A as the TENS group and B as the control group, Blinding description: The present study is double-blind because the person collecting the information will not be aware of the group of people. The data analyst will not be aware of the group of people. N/A Osteoporotic hip and femur fractures. Intervention 1: Intervention group: In the intervention group, after receiving the standard post-surgery treatment, physiotherapy with a device with a frequency of 180-250 volts is performed every morning for 30 minutes by a physiotherapist, depending on the patient's tolerance. Each treatment session includes transfer training, balance exercises, lower limb exercises and ambulatory exercises that are performed at the end of the session. Before walking, four self-adhesive neuromuscular stimulation electrodes measuring 4 square centimeters are attached to the patient's skin on both sides of the surgical incision. Electrical stimulation (TENS) is performed every morning for 30 minutes for 5 days. On the first day, TENS treatment is provided after the physiotherapy session. On days 2 to 5, TENS is applied during ambulatory exercise (10 to 15 minutes) and a seated rest period afterward. Intervention 2: Control group: patients in the control group only receive the standard treatment of postoperative patients. 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 Due to the continuation of the study, no decision has been made to publish it yet.
public Mohammadreza Rasouli
Valiasr hospital, Valiasr Squre, Arak
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mrr1996@yahoo.com Arak University of Medical Sciences scientific Mohammadreza Rasouli
Valiasr hospital, Valiasr Squre, Arak
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mrr1996@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients who, according to the clinical and radiographic findings, suffered a fracture in the pelvis or proximal femur. no limit no limit Both Patients who die during surgery or after discharge Patients who do not want to cooperate M80 Osteoporosis with current pathological fracture Treatment - Other Treatment - Other Intervention group: In the intervention group, after receiving the standard post-surgery treatment, physiotherapy with a device with a frequency of 180-250 volts is performed every morning for 30 minutes by a physiotherapist, depending on the patient's tolerance. Each treatment session includes transfer training, balance exercises, lower limb exercises and ambulatory exercises that are performed at the end of the session. Before walking, four self-adhesive neuromuscular stimulation electrodes measuring 4 square centimeters are attached to the patient's skin on both sides of the surgical incision. Electrical stimulation (TENS) is performed every morning for 30 minutes for 5 days. On the first day, TENS treatment is provided after the physiotherapy session. On days 2 to 5, TENS is applied during ambulatory exercise (10 to 15 minutes) and a seated rest period afterward. Control group: patients in the control group only receive the standard treatment of postoperative patients. After the surgery, the level of pain is checked with the help of the vas score questionnaire during a 5-day intervention period as explained below: once during the first 24 hours after the surgery, before applying physiotherapy and TENS, and then Immediately before each session of physiotherapy and TENS application, by asking the participant, the intensity of pain at night and at rest, the amount of pain experienced the night before and while resting in bed or sitting in a chair during the day is evaluated.In the following, the pain level is assessed once in two weeks after the surgery when the patient visits the orthopedic clinic. Also, the pain level will be measured once with the help of VAS 3 months after the surgery. Timepoint: once during the first 24 hours after the surgery, before applying physiotherapy and TENS, and then Immediately before each session of physiotherapy and TENS application, by asking the participant, the intensity of pain at night and at rest, the amount of pain experienced the night before and while resting in bed or sitting in a chair during the day is evaluated.In the following, the pain level is assessed once in two weeks after the surgery when the patient visits the orthopedic clinic. Also, the pain level will be measured once with the help of VAS 3 months after the surgery. Method of measurement: VAS questionnaire to measure the pain level of patients: Visual analog scale (VAS) is a tool that is widely used to measure pain. The patient is asked to indicate their perceived pain intensity (usually) along a 100 mm horizontal line and this rating is then measured from the left edge (= VAS score). VAS score correlates well with acute pain level. Partial weight walking. Timepoint: Before discharge. Method of measurement: The amount of distance traveled in two minutes. Full weight walkinf. Timepoint: After discharg. Method of measurement: The time required to reach the full weight setup of 10 steps. Arak University of Medical Sciences Approved 2022-03-12 Research ethics committees of Arak University of Medical Sciences ŮŽArak Univercity of Medical Science, Arak Arak Markazi Iran (Islamic Republic of)