The Effects of Lumbosacral Orthosis on the Pain Management and Load Transfer of the Sacroiliac Joint in Women with Postpartum Pelvic Pain: A Parallel-Group Clinical Study
This study aimed to compare the effectiveness of sacroiliac belt as an usual intervention and new-designed lumbosacral orthosis (LSO) on pain management and load transfer in women with post-partum posterior pelvic pain.
Design
This study will be a prospective randomized-controlled clinical trial with two parallel groups. Based on previous study, the target sample size of 60 will be randomly assigned into control or intervention group by block randomization method.
Settings and conduct
Eligible subject will be recruited from the obstetric-outpatient clinics of Isfahan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) Primipara women, natural delivery (one-month before) (2) Self-reported pregnancy-related pelvic pain (3) Pain score of at least 30 (4) Effort score of higher than 2 (5) Age between 18 and 45 years (6) Ability to read and write in Persian language (7) Unilateral sacroiliac joint pain
Exclusion criteria: (1) Presence of low back and/or pelvic pain before pregnancy (2) History of spine, pelvis, and lower extremities surgery (3) Limb length discrepancy (4) Congenital anomaly in the spine, pelvis, and lower extremities (5) History of any fracture in lower extremities (6) Using any other conservative treatment for pain relief (7) Symptoms of pathological disease like fever and involuntary weight loss (8) Score of pain ≥ 8 (9) Neurological, inflamatory diseases
Intervention groups
Two groups will be considered for this study. Control and intervention group will receive sacroilaic belt and lumbosacral orthosis (LSO) , respectively
Main outcome variables
Pain during active straight leg raise (ASLR)
Effort score during ASLR
Maximum isometric hip flexion force
Maximum isometric trunk rotation force
Maximum isometric hip external rotation force
Joint position reproduction (JPR) of hip abduction
Disability score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N11
Registration date:2021-05-31, 1400/03/10
Registration timing:registered_while_recruiting
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
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
2021-04-09, 1400/01/20
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Lumbosacral Orthosis on the Pain Management and Load Transfer of the Sacroiliac Joint in Women with Postpartum Pelvic Pain: A Parallel-Group Clinical Study
Public title
The Effects of Lumbosacral Orthosis on Pain in Postpartum Pelvic Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primipara women experienced natural delivery (one-month before)
Self-reported pregnancy-related pelvic pain
A pain score of at least 30 out of 100 on the visual analog scale (VAS)
A score of higher than 2 out of 5 on a 6-point Likert scale
Age between 18 and 45 years
Ability to read and write in Persian language
Confirm the unilateral sacroiliac joint pain
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Intervention allocation will be carried out by block randomization method such that an equal number will be assigned to each study group. Once participant is confirmed eligible, she will be randomly assigned to either pelvic belt (control) or LSO (intervention) group (ratio 1:1). Based on block randomization (each block, n=4), there will be 6 possible ways to assign participants to a block: 1122, 1212, 1221, 2112, 2121, 2211 (1= pelvic belt, 2= LSO). Examiner will choose blocks randomly and will allocate participants according to the serial assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In present study, only researcher will be aware about the intervention allocated to each participant. Examiner will choose blocks randomly and will allocate participants according to the serial assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-24, 1400/03/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.007
Health conditions studied
1
Description of health condition studied
Pregnancy related sacroiliac posterior pelvic pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Pain severity
Timepoint
Pain score will be measured at three stages: a) The first session is to assess the outcome measure at baseline and the immediate effect of interventions. b) The second session will be a follow-up four-week after the initial assessments. c) The third session will measure at one-week after discontinuing intervention.
Method of measurement
She will score her pain during the test by visual analog scale (VAS) ranged from 0 to 10; zero means no pain, and 10 presents the worst imaginable pain.
2
Description
Effort score during active straight leg raising test
Timepoint
Effort score will be measured at three stages: a) The first session is to assess the outcome measure at baseline and the immediate effect of interventions. b) The second session will be a follow-up four-week after the initial assessments. c) The third session will measure at one-week after discontinuing intervention.
Method of measurement
Participants will score the difficulty to perform the test on a 6-point Likert scale ranging from 0 to 5; zero presents no difficulty, and five means unable to do
3
Description
Maximum isometric hip flexion force
Timepoint
Effort score will be measured at three stages: a) The first session is to assess the outcome measure at baseline and the immediate effect of interventions. b) The second session will be a follow-up four-week after the initial assessments. c) The third session will measure at one-week after discontinuing intervention.
Method of measurement
Digital force gauge , SF-500, Akurasi, 0.001kg, will be attached to the metal bar and adjusted in which is located just above the ankle. The participant will be asked to raise her involved leg and compress the force gauge probe while the leg is still lying on the table.
4
Description
Maximum isometric hip external rotation force
Timepoint
Effort score will be measured at three stages: a) The first session is to assess the outcome measure at baseline and the immediate effect of interventions. b) The second session will be a follow-up four-week after the initial assessments. c) The third session will measure at one-week after discontinuing intervention.
Method of measurement
Participants will undergo isometric muscle strength testing for hip external rotation using digital force gauge and a stabilization strap. The subject will be instructed to pull her leg inward with maximal effort until force value is displayed on the force gauge.
5
Description
Maximum isometric trunk rotation force
Timepoint
Effort score will be measured at three stages: a) The first session is to assess the outcome measure at baseline and the immediate effect of interventions. b) The second session will be a follow-up four-week after the initial assessments. c) The third session will measure at one-week after discontinuing intervention.
Method of measurement
This variable will be measured using digital force gauge (Model: SF-500, Akurasi, 0.001kg) Participant will be positioned on the chair in the upright sitting position. The subjects will be asked to rotate her trunk toward the opposite side and exert isometric force to force gauge probe.
6
Description
Joint position reproduction (JPR) of hip abduction
Timepoint
Effort score will be measured at three stages: a) The first session is to assess the outcome measure at baseline and the immediate effect of interventions. b) The second session will be a follow-up four-week after the initial assessments. c) The third session will measure at one-week after discontinuing intervention.
Method of measurement
This variable will be measured while subject standing. Three passive markers will be attached to the apex of the iliac crest, greater trochanter, and lateral femur epicondyle. Movement kinematics of markers will be captured using a Canon camera (EOS-500D, DS126231, Japan) placed behind the participant at a distance of 2.5m. The camera’s tracking angles will be analyzed by Kinovea software (0.9.2, GPLv2 license, 2019).
7
Description
Disability score
Timepoint
Effort score will be measured at three stages: a) The first session is to assess the outcome measure. b) The second session will be a follow-up four-week after the initial assessments. c) The third session will measure at one-week after discontinuing intervention.
Method of measurement
The Persian version of ODI will be used to quantify disability in women with post-partum pelvic pain. The tool is a 10-item questionnaire which mainly questioning about pain intensity related to the daily activities.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lumbosacral orhosis (LSO) The participants will receive LSO. It is made from breathable textile material to provide comfort for the participant. The LSO will provide circumferential pressure on the torso and pelvic area. The LSO includes four semi-rigid bars inserted vertically to the posterior part to support the stability of the lower back. Three anterior panels (width about 10cm) will be incorporated in the orthosis. Transverse compression panel will be fastened just under anterior superior iliac spine (ASIS) in pelvic belt location. Two diagonal straps are obliquely fastened around the abdominal wall (like oblique muscle orientation) .Both orthoses will be available in different sizes and fitted individually by a trained examiner to provide the best possible personalized orthosis.
Category
Treatment - Devices
2
Description
Control group: Pelvic belt The participants will receive a pelvic belt. It is made from breathable textile material to provide comfort for the participant. The pelvic belt will be an adjustable strap (width 10-15cm) fastened just under ASIS. Belt will be available in different sizes and fitted individually by a trained examiner to provide the best possible personalized orthosis. The fitting method of orthosis will be explained and demonstrated to all users.