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IRCT20220330054372N1 IRCT 2022-05-08 Esfahan University of Medical Sciences The effect of the pelvic belt on muscle activity of the pelvis muscles in pregnant women with pregnancy-related pelvic pain: A parallel-groups clinical study The effect of the pelvic belt on muscle activity of the pelvis muscles in pregnant women with pregnancy-related pelvic pain: A parallel-groups clinical study 2022-04-21 anticipated 51 Complete https://irct.ir/trial/62697 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of study groups is a blocking method. The method of doing it is as follows. The size of each block or the number of people in each block is 3 people. Meanwhile, three groups in this study (17 Healthy Pregnant or HP pregnant women, 17 pregnant women with pelvic pain with manual (control group or C) and,17 pregnant women with pelvic pain with the pelvic girdle (group) There is an Intervention Group or IG, the arrangement of the members of each block as (IG, HP, C), (IG, C, HP), (C, IG, HP), (C, HP, IG), (HP, C, IG), (HP, IG, C) In the next step, these 6 states are written on paper and poured into a container. 1 Pelvic pain in pregnant women (in the posterior pelvic area). Intervention 1: Intervention group: This group includes 17 pregnant women with pelvic pain related to pregnancy. This group is given a slim and flexible pelvis. This belt should be located in the pubic area or pubis. First, women adjust the pelvic belt on their body, and then, they adjust the pelvic belt pressure on both sides through Velcro elastic systems. This pelvic belt is adaptable for different stages of pregnancy due to the Velcro and elastic system. On the first day, according to the waist circumference of the person participating in the study, the appropriate size is selected. The person is taught how to wear a belt. The pelvic girdle of the intervention group is worn during awakening and during the day for two hours and thirty minutes, for 14 days. Intervention 2: Control group: This group includes 17 pregnant women with pelvic pain related to pregnancy. These people are given a logbook. Control group members must follow the instructions in the manual for 14 days. The information in this guide includes recommendations for identifying the factors that contribute to pelvic pain and, appropriate lifestyle (posture correction while sitting, walking and sleeping) to prevent and reduce pelvic pain in pregnant women. Intervention 3: Comparison group: This group includes healthy women without pelvic pain, who have no intervention. This group is present in this study only to compare surface electromyography evaluations of muscles with the intervention group. Yes - There is a plan to make this available What will be shared: Study information (other than personal information) is shared with other researchers. When: Information is shared after the results are printed or summarized. To whom: Information will be shared for academic purposes only. Conditions: Information is shared to teach and research applicants. Where to obtain: Individuals can request information from the person in charge. How to obtain: Requests should be sent by email (sadeghi@rehab.mui.ac.ir). Comments:
public Ebrahim Sadeghi-Demneh
School of Rehabilitation, Esfahan University of Medical Sciences, Hezar Jerib St., Esfahan.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5018 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ebrahim Sadeghi-Demneh
School of Rehabilitation, Esfahan University of Medical Sciences, Hezar Jerib St., Esfahan.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5018 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria for pregnant women with pelvic pain: 1. Pregnant women with pelvic pain, between the ages of 25 and 35 who are experiencing their first pregnancy. 2. Pelvic pain in these women, should be from 18 weeks onwards, with pain in the sacroiliac joints and/or pubic area. 3. The result of two tests from the mentioned tests (posterior pelvic pain stimulation test, Patrick Faber's test, Trendelenburg test, and active straight leg test) should be positive during the clinical examination. 4. According to the VAS assessment, the rate of pelvic pain in pregnant women should be higher than 3 out of10. Inclusion criteria for healthy pregnant women without pelvic pain: 1. Healthy pregnant women between the ages of 25 and 35 who are experiencing their first pregnancy. 25 years 35 years Female Exclusion criteria for pregnant women with pelvic pain: 1. Pelvic pain and low back pain before pregnancy. 2. Red flags symptoms 3. Multiple pregnancies 4. Pregnancies with complications and other diseases such as systemic diseases. Exclusion criteria for healthy pregnant women without pelvic pain: 1. Pelvic pain and low back pain before and after pregnancy. 2. During the clinical examination, even if one of the tests for posterior pelvic pain stimulation, Patrick Fabers, the modified Trendelenburg test and, the active straight leg test are positive. 3. Red flag symptoms. 4. Multiple pregnancies. 5. Pregnancies with complications and other diseases such as systemic diseases. R10.2 Pelvic and perineal pain Treatment - Devices Rehabilitation N/A Intervention group: This group includes 17 pregnant women with pelvic pain related to pregnancy. This group is given a slim and flexible pelvis. This belt should be located in the pubic area or pubis. First, women adjust the pelvic belt on their body, and then, they adjust the pelvic belt pressure on both sides through Velcro elastic systems. This pelvic belt is adaptable for different stages of pregnancy due to the Velcro and elastic system. On the first day, according to the waist circumference of the person participating in the study, the appropriate size is selected. The person is taught how to wear a belt. The pelvic girdle of the intervention group is worn during awakening and during the day for two hours and thirty minutes, for 14 days. Control group: This group includes 17 pregnant women with pelvic pain related to pregnancy. These people are given a logbook. Control group members must follow the instructions in the manual for 14 days. The information in this guide includes recommendations for identifying the factors that contribute to pelvic pain and, appropriate lifestyle (posture correction while sitting, walking and sleeping) to prevent and reduce pelvic pain in pregnant women. Comparison group: This group includes healthy women without pelvic pain, who have no intervention. This group is present in this study only to compare surface electromyography evaluations of muscles with the intervention group. Surface electromyography. Timepoint: In the first session, all participants participate in an electromyographic evaluation once. In the same session, after wearing the pelvic belt, the intervention group performs an electromyography evaluation. In the intervention group, the pelvic belt is worn during awakening and during the day for two hours and thirty minutes, for 14 days. The control group (receiving the manual) and the intervention group perform electromyographic evaluations on day 14. Method of measurement: The muscles are evaluated in a standing position, through superficial electrodes in the distal and proximal pelvic muscles (posterior thigh muscles (long biceps and tendon muscle), gluteus maximus, multifidus muscles (level two L1 and L5) and, internal oblique muscles are examined. The signals recorded by the kinesiological EMG ME 6000 electromyography device are stored on the laptop through the Mega Win software. After deleting the beginning and end of the recorded values, the duration is 10 seconds out of 20 seconds. Information processing is done by MATLAB software. (Intensity of pain) Visual Analogue Scale. Timepoint: In the first session, all participants will be assessed for pain intensity once. In the same session again, after wearing the pelvic belt, the intervention group is evaluated. In the intervention group, the pelvic belt is worn during awakening and during the day for two hours and thirty minutes, for 14 days. The control group (receiving the manual) and the intervention group perform electromyographic evaluations on day 14. Method of measurement: It consists of a 10 cm line, which is placed horizontally on a piece of paper. A dot is placed on it at each end. One point of this line indicates "no pain", and the other point indicates "maximum perceived pain intensity". Individuals assess their perceived pain intensity by marking on this horizontal scale line. The distance from the point of no pain to this person-marked mark is measured by a ruler. This symptom is used as the overall score of pain intensity. This distance is measured in millimeters to determine the scores from 0 to 100. The study participant is asked to indicate the pain they are currently experiencing in a vertical line on this scale. Pelvic Girdle Questionnaire. Timepoint: In the first session, all participants will have a pelvic pain questionnaire once. In the same session again, after wearing the pelvic belt, the intervention group is evaluated. In the intervention group, the pelvic belt is worn during awakening and during the day for two hours and thirty minutes, for 14 days. The control group (receiving the manual) and the intervention group perform the evaluations on the 14th day. Method of measurement: The pelvic pain questionnaire is used as an advanced specialized tool to assess patients with pelvic girdle pain. This questionnaire includes items related to the activity, participation and physical symptoms of the person. The pelvic girdle questionnaire is suitable for both pregnant and post-pregnancy women with pelvic pain. Participants are asked to carefully complete the questionnaire form. Pain Catastrophizing Scale. Timepoint: In the first session, all participants will be assessed once on the Catastrophic Pain Scale questionnaire. In the same session again, after wearing the pelvic belt, the intervention group is evaluated. In the intervention group, the pelvic girdle is worn during awakening and during the day for two hours and thirty minutes, for 14 days. The control group (receiving the manual) and the intervention group perform the evaluations on the 14th day.Participants are asked to carefully complete the questionnaire form. Method of measurement: The Catastrophizing Pain Scale Questionnaire, a 13-item scale that assesses patients' catastrophic thoughts and behaviors when faced with pain, consists of three subscales of mental rumination, exaggeration, and despair. Participants are asked to carefully complete the questionnaire form. Esfahan University of Medical Sciences Approved 2022-05-02 Ethics Committee of Esfahan University of Medical Sciences, ‌ Isfahan, Iran School of Rehabilitation, Esfahan University of Medical Sciences, Hezar Jerib St., Esfahan. Esfahan Isfehan Iran (Islamic Republic of)