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IRCT20150210021034N11 IRCT 2021-05-31 Esfahan University of Medical Sciences The Effects of Lumbosacral Orthosis on Pain in Postpartum Pelvic Pain 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 2021-04-09 anticipated 60 Complete https://irct.ir/trial/54808 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Pregnancy related sacroiliac posterior pelvic pain. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shared with other researchers or systematic reviewers. When: Data will be shared once findings are come up or summary date is published. To whom: Data will be shared personally and for academic purposes only. Conditions: Data will be shared for teaching or research. Dr Sadeghi (correspondence) will review the requests. Where to obtain: People can sent their request to the correspondence and obtain the data. How to obtain: Request should be sent through an email (sadeghi@rehab.mui.ac.ir). Comments:
public Ebrahim Sadeghi
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5053 sadeghi@rehab.mui.ac.ir Esfarayen University of Medical Sciences scientific Ebrahim Sadeghi
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5053 sadeghi@rehab.mui.ac.ir Esfarayen University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Female R10.2 Pelvic and perineal pain Treatment - Devices Treatment - Devices 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. 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. 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. 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. 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. 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. 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. 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). 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. Esfahan University of Medical Sciences Approved 2021-05-24 Ethical committee of Isfahan University of Medical Sciences, Isfahan, Iran Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)