Protocol summary
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Study aim
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The design and construction of the modified lumbar pelvic belt and compares its effect on back and pelvic muscle activity and pain with the conventional pelvic belt in pregnant women
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Design
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According to clinical trial studies, participants in the study (48 people) were randomly divided into three groups. One group will be given a common pelvic girdle, the other group will be given a modified pelvic girdle belt made by the research team, to the third group none of the belts Will not be prescribed (control group).
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Settings and conduct
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This study will be performed in Kosar specialized and sub-specialized clinic in Arak. Pelvic Girdle, SF36, DIO, and pain intensity questionnaires will be used. The muscular activity of the lumbar and pelvic muscles will be evaluated during the ASLR, trunk flexion extension, sitting-standing up, and walking in different positions using the belts. Blinding is one-sided
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include:
Pregnant women from the 20th week of pregnancy
Pregnant women with moderate to severe pain
Age under 40 years
Single pregnancy
Clinical diagnosis of low back pain or pelvic pain based on what people say
Criteria for non-entry include:
Pregnant women with a history of surgery on the spine or pelvis
Pregnant women with a history of back pain and pelvic pain before pregnancy
Systemic diseases
Any signs of high-risk pregnancy
Twin pregnancy
Depression
Neurological diseases
Common use of NSAIDs or any medication containing corticosteroids in the last 30 days
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Intervention groups
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The first intervention group will be given a common pelvic girdle, the second intervention group will be given a modified pelvic girdle made by the research team, and the control group will not be given any of the belts.
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Main outcome variables
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Lumbar or Pelvic pain; Lumbar muscle activity; Pelvic muscle activity; Function; Quality of life
General information
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Reason for update
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Add a new variable
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200925048833N1
Registration date:
2020-12-23, 1399/10/03
Registration timing:
prospective
Last update:
2022-09-10, 1401/06/19
Update count:
1
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Registration date
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2020-12-23, 1399/10/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-21, 1400/01/01
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Expected recruitment end date
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2021-05-22, 1400/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The design and construction of the modified lumbar pelvic belt and compares its effect on back and pelvic muscle activity and pain with the conventional pelvic belt in pregnant women
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Public title
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The effect of modified lumbar pelvic belt on back and pelvic muscle activity and pain in pregnant women
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women from the 20th week of pregnancy
Pregnant women with moderate to severe pain (Pain intensity 4 and above in VAS)
Age under 40 years
Single pregnancy
Clinical diagnosis of low back pain or pelvic pain based on the individual's own statement, negative answer to research questions and positive result of at least one of the following tests:1. Patrick's/Faber Test 2. posterior pelvic pain provocation 3.Modified Trendelenberg Test with direct palpation of the symphysis pubis 4.Active straight leg raise test
Exclusion criteria:
Pregnant women with a history of surgery on the spine or pelvis
Pregnant women with a history of back pain and pelvic pain before pregnancy
Systemic diseases such as restrictive lung diseases, heart disease and diabetes
Any signs of high-risk pregnancy
Twin pregnancy
Depression
Neurological diseases
Common use of NSAIDs or any medication containing corticosteroids in the last 30 days
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Age
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To 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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According to clinical trial studies, participants in the study are randomly divided into three groups (first intervention, second intervention and control).The method of allocating samples in control and intervention groups is done in a simple randomization based on the lottery of sample members (individual randomization unit).In this method, using a table of random numbers, one of the numbers is touched and moved in one of the predetermined directions, each member of the sample whose number was selected, will be divided into one of the study groups, respectively. .
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-12, 1399/06/22
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Ethics committee reference number
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IR.USWR.REC.1399.161
Health conditions studied
1
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Description of health condition studied
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Low back pain
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ICD-10 code
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M54.05
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ICD-10 code description
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Panniculitis affecting regions of neck and back, thoracolumbar region
2
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Description of health condition studied
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Pelvic pain
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ICD-10 code
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R10.2
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ICD-10 code description
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Pelvic and perineal pain
Primary outcomes
1
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Description
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lumbar or pelvic Pain
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Timepoint
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At the beginning of the study and three weeks after using the belts
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Method of measurement
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Visual Analogue Scale
2
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Description
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function
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Timepoint
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At the beginning of the study and three weeks after using the belts
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Method of measurement
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Pelvic Girdle Questionnaire, Disability Index Oswestry Questionnaire
3
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Description
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lumbar muscle activity
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Timepoint
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At the beginning of the study and three weeks after using the belts
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Method of measurement
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Surface Electromyography Device
4
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Description
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pelvic muscle activity
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Timepoint
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At the beginning of the study and three weeks after using the belts
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Method of measurement
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Surface Electromyography Device
5
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Description
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Quality of life
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Timepoint
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At the beginning of the study and three weeks after using the belts
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Method of measurement
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SF36 Questionnaire
Intervention groups
1
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Description
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Intervention group 1: Common pregnancy pelvic belt with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion and extension, sitting and standing up, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Pain Intensity Scale, Pelvic Girdle questionnaire, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
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Category
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Rehabilitation
2
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Description
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Intervention group 2: Pregnancy lumbar and pelvic belt made by the research team with common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyographic device in the positions of Active straight leg raise test, trunk flexion, and extension, sitting and standing, and walking. As a result, muscle activity is assessed immediately before the belt is fastened and after the belt is administered. After three weeks of using the belts for 4 to 5 hours daily and during the activity, the pain intensity Scale, Pelvic Girdle questionnaire, Disability Index Oswestry, and SF36 are completed for them again. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded without using and using the belt in all previous cases.
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Category
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Rehabilitation
3
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Description
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Control group: Common advice For individuals, demographic questionnaires, visual analogue scale, Pelvic Girdle questionnaire to assess pain, activity, and disability, Disability Index Oswestry questionnaire to assess performance, and SF36 questionnaire to evaluate the quality of life will be completed. Also, the muscular activity of the back and pelvis is performed and recorded using a surface electromyography device in the positions of - active straight leg raise test - trunk flexion and extension - sitting and standing - walking. Then They are given common advice on preventing back and pelvic pain. After three weeks, they complete the Pain Intensity Scale, the Pelvic Girdle Questionnaire, the Disability Index Oswestry, and SF36. Also, the muscular activity of the lumbar and pelvic muscles is performed and recorded in all previous cases.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of social welfare and rehabilitation sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All of the above will be published in the article.
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When the data will become available and for how long
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There will be access after the article is published.
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To whom data/document is available
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After the article is published, researchers can access it.
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Under which criteria data/document could be used
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Other researchers, obstetricians, therapists in the field of medicine and rehabilitation can use this research after the publication of the article.
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From where data/document is obtainable
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Refer to the published articles of this research.
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What processes are involved for a request to access data/document
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Refer to the published articles of this research.
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Comments
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