To investigate the immediate effects of a pelvic belt with a textured sacral pad in pregnant women with lumbopelvic pain
Design
This is a randomized crossover study in which 28 pregnant women with pelvic pain diagnosed by an obstetrics and gynecology specialist pelvic symptoms according to specific diagnostic criteria. ،There are three interventions and the order of intervention and testing conditions are randomized. This is a single blind study and in data analysis people are unaware of group designations.
Settings and conduct
This study run in Alzahra hospital, Isfahan, Iran. The testing protocol was started after pelvic belts were fitted and 5 minutes acclimatization. Participants were given about 10 minutes rest before the crossed-over to the next pelvic belt.
Pelvic belt effects were investigated under three random conditions: without pelvic belt application, with a pelvic belt, and adding a textured sacral pad inside the same pelvic belt.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Increase in the pain intensity with changing the position and decrease in the pain with resting
Exclusion Criteria: History of trauma or surgery in the lower back or pelvis, history of sacroiliac pain before the first pregnancy, signs of neural radiculopathy, or presence of visceral or vaginal pains
Intervention groups
Control Group: no pelvic belt (control), intervention group 1: routine pelvic belt, and intervention group 2: Pelvic belt with sacral pad
Main outcome variables
Outcome measures: the hip proprioception, effort during single leg raising, and maximum isometric hip flexion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N2
Registration date:2019-07-18, 1398/04/27
Registration timing:retrospective
Last update:2019-07-18, 1398/04/27
Update count:0
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Ebrahim Sadeghi-Demneh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5235
Email address
sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-08-21, 1396/05/30
Trial completion date
2017-09-21, 1396/06/30
Scientific title
The immediate effects of pelvic compression belt with a textured sacral pad on the sacroiliac function in the pregnant women with lumbopelvic pain
Public title
Pelvic Belt in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Increase in pain intensity with changing position
Decrease in pain intensity with resting
Exclusion criteria:
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
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
IR.MUI-REC-1395.3.318
Health conditions studied
1
Description of health condition studied
Pelvic pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: without pelvic belt
Category
N/A
2
Description
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.
Category
Rehabilitation
3
Description
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