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IRCT20221101056365N1 IRCT 2022-12-18 Arak University of Medical Sciences Effect of Trans cutaneous Electrical Nerve Stimulation(TENS) on fractures Effect of Trans cutaneous Electrical Nerve Stimulation (TENS) on health-related quality of life , Harris hip score and mortality rate in patients after surgical treatment of osteoporotic hip and pre-trochanteric fractures 2022-03-29 anticipated 370 Complete https://irct.ir/trial/66696 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Non-random sampling will be available. Then, the examined samples in this study will be placed in the investigated groups (control and TENS intervention) random allocation sequence was done using Random Allocation software. In the software, enter the sample size number (370) and the software randomly divided the numbers from 1 to 370 into two equal groups, A and B, and we considered the numbers A as the control group and B as the TENS group, Blinding description: The present study is double-blind because the participants who receive the intervention are aware of the intervention. 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 is performed by the physiotherapist every morning for 30 minutes with a device with a frequency of 180-250 volts, 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 yet.
public Mohammad Reza Bozorgmanesh
Valiasr hospital, Valiasr square, Arak
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 m.bozorgmanesh@arakmu.ac.ir Arak University of Medical Sciences scientific Mohammad Reza Bozorgmanesh
Valiasr hospital, Valiasr square, Arak
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 m.bozorgmanesh@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Osteoporotic hip and pre-trochanteric fractures patients Over 50 years patients 50 years no limit Both Patients with unwillingness to cooperate M16 Osteoarthritis of hip Treatment - Other Treatment - Other Intervention group: In the intervention group, after receiving the standard post-surgery treatment, physiotherapy is performed by the physiotherapist every morning for 30 minutes with a device with a frequency of 180-250 volts, 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. Quality of life. Timepoint: 1, 3, 6 , 12 month after surgery. Method of measurement: SF36 questionnaire. Hip function. Timepoint: 1, 3, 6 and 12 month after surgery. Method of measurement: Harris hip score. Mortality. Timepoint: Immediately and 1, 3 , 6 , 12 month after surgery. Method of measurement: Check list. Arak University of Medical Sciences Approved 2022-04-02 Research ethics committees of Arak University of Medical Sciences ŮŽArak Univercity of Medical Science, Arak Arak Markazi Iran (Islamic Republic of)