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IRCT20200925048833N1 IRCT 2020-12-23 University of social welfare and rehabilitation sciences The effect of modified lumbar pelvic belt on back and pelvic muscle activity and pain in pregnant women 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 2021-03-21 anticipated 48 Complete https://irct.ir/trial/53019 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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. . N/A Condition 1: Low back pain. Condition 2: Pelvic pain. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: All of the above will be published in the article. When: There will be access after the article is published. To whom: After the article is published, researchers can access it. Conditions: Other researchers, obstetricians, therapists in the field of medicine and rehabilitation can use this research after the publication of the article. Where to obtain: Refer to the published articles of this research. How to obtain: Refer to the published articles of this research. Comments:
public Zhaleh Heidari
University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blvd, Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2000 webmaster@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Zhaleh Heidari
University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blvd, Evin, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2000 webmaster@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) 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 no limit 40 years Female 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 M54.05 R10.2 Panniculitis affecting regions of neck and back, thoracolumbar region Pelvic and perineal pain Rehabilitation Rehabilitation Rehabilitation 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. 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. 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. Lumbar or pelvic Pain. Timepoint: At the beginning of the study and three weeks after using the belts. Method of measurement: Visual Analogue Scale. Function. Timepoint: At the beginning of the study and three weeks after using the belts. Method of measurement: Pelvic Girdle Questionnaire, Disability Index Oswestry Questionnaire. Lumbar muscle activity. Timepoint: At the beginning of the study and three weeks after using the belts. Method of measurement: Surface Electromyography Device. Pelvic muscle activity. Timepoint: At the beginning of the study and three weeks after using the belts. Method of measurement: Surface Electromyography Device. Quality of life. Timepoint: At the beginning of the study and three weeks after using the belts. Method of measurement: SF36 Questionnaire. University of social welfare and rehabilitation sciences Approved 2020-09-12 Ethics committee of University of Social Welfare and Rehabilitation Sciences University of Social Welfare and Rehabilitation Sciences, kodakyar Ave, daneshjoo Blvd, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)