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IRCT20150210021034N2 IRCT 2019-07-18 Esfahan University of Medical Sciences Pelvic Belt in pregnant women The immediate effects of pelvic compression belt with a textured sacral pad on the sacroiliac function in the pregnant women with lumbopelvic pain 2016-09-22 anticipated 25 Complete https://irct.ir/trial/40275 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: This is a randomized controlled crossover study, during which participants acted as their controls (no pelvic belt) and compared to two pelvic belts (including a routine pelvic belt and pelvic belt with a textured sacral pad) in a single session.The order of intervention and testing conditions were randomized and determined by taking a concealed draw from a hat. N/A Pelvic pain. Intervention 1: Control group: without pelvic belt. Intervention 2: Intervention group 1: Routine pelvic belt. The belt used in this study was a non-stretchable material made of nylon webbing, which was about 5 cm wide at the anterior and 7 cm at the posterior side. Four different sizes of the belt were available, were selected according to the pelvic circumference of each participant. The belt was fastened with a Velcro and positioned just below the anterior superior iliac spine. The compression force applied on the fastening Velcro was set at 50N and controlled within the study conditions using a force measurement apparatus. Intervention 3: Intervention group2: Pelvic belt with textured sacral pad. The sacral pad attached to the pelvic belt (Intervention 2) was an equilateral triangle (each side: 12 cm) made by silicone rubber (thickness of base: 1.5cm, shore value: A40). Twelve convex circular spikes (with 1cm height) were incorporated over the sacral pad; the pick-to-pick distance of the spikes was 2 cm. Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shred with other researchers or systematic reviewers. When: No time limit is set. To whom: No specific limitation is considered. Conditions: No terms and conditions is considered for sharing the data. Where to obtain: People can sent their request to the correspondence and obtain the data. How to obtain: Request can be sent through an email. Comments:
public Ebrahim Sadeghi-Demneh
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5235 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ebrahim Sadeghi-DEmneh
Hezar Jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5235 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Increase in pain intensity with changing position Decrease in pain intensity with resting no limit no limit Female History of trauma or surgery in the lower back or pelvis History of sacroiliac pain before the first pregnancy Signs of radiculopathy Presence of visceral or vaginal pains R10.2 Pelvic and perineal pain N/A Rehabilitation Rehabilitation Control group: without pelvic belt Intervention group 1: Routine pelvic belt. The belt used in this study was a non-stretchable material made of nylon webbing, which was about 5 cm wide at the anterior and 7 cm at the posterior side. Four different sizes of the belt were available, were selected according to the pelvic circumference of each participant. The belt was fastened with a Velcro and positioned just below the anterior superior iliac spine. The compression force applied on the fastening Velcro was set at 50N and controlled within the study conditions using a force measurement apparatus. Intervention group2: Pelvic belt with textured sacral pad. The sacral pad attached to the pelvic belt (Intervention 2) was an equilateral triangle (each side: 12 cm) made by silicone rubber (thickness of base: 1.5cm, shore value: A40). Twelve convex circular spikes (with 1cm height) were incorporated over the sacral pad; the pick-to-pick distance of the spikes was 2 cm Hip proprioception. Timepoint: This outcome is measured immediately after fastening the pelvic belt. Method of measurement: Hip proprioception is evaluated by measurement of the active angle reproduction in hip abduction. The participant's eyes are closed during proprioceptive testing. Participate are positioned supine and instructed to abduct the thigh with an extended knee until it reached 20 degrees abduction at the hip and the assessor indicated "stop". They are asked to concentrate on this target angle for 5 seconds and memorize it. The lower limb passively returned to the starting position by the assessor. Participants attempted to reproduce the target angle with an active thigh abduction. Each test is repeated three times for each side, and angle error was calculated as a mean absolute error and used as the proprioceptive outcome measure. Maximum isometric hip flexion. Timepoint: This outcome is measured immediately after fastening the pelvic belt. Method of measurement: The maximum isometric hip flexion is measured with an extended knee at the end of active single leg raising test (20 cm above the table). A non-elastic 5 cm width belt restricted the hip flexion once the ankle reached 20 cm height and the force that applied to the belt was recorded using a digital force gauge. Effort in active single leg raising. Timepoint: This outcome is measured immediately after fastening the pelvic belt. Method of measurement: Participants are asked to rate their effort in performing active single leg raising on a six-point Likert scale: 0=not difficult, 1=minimally difficult, 2=somewhat difficult, 3=fairly difficult, 4=very difficult, and 5=unable to perform. Esfahan University of Medical Sciences Approved 2016-05-21 Ethics committe of Isfahan University of Medical Sciences Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)