Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain

Study Overview
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Brief Summary
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This study investigates the effects of pelvic belt (PB) and kinesio taping (KT) applications on pain and functional mobility in pregnancy-related pelvic girdle pain (PGP), in comparison with the control group that received only pain neuroscience education and ergonomic training.

Detailed Description
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Although there is strong evidence in the literature that pelvic support belts reduce pain in pregnancy-related pelvic girdle pain, no study investigating its effect on functional mobility with performance-based measurement methods or investigating its effectiveness on kinesiophobia has been found. Studies investigating the efficacy of KT in pregnant women with PGP are few and many are methodologically weak studies, most of which do not contain randomization and control groups. Also, no study has been found in the literature, which compares the effectiveness of PB and KT in pregnant women with PGP. Therefore, the primary aim of this study is to examine the effects of PB and KT on pain and functional mobility in pregnant women with PGP in comparison with the control group, which is only given pain neuroscience education and ergonomic training. The secondary aims are to investigate the effects of these applications on kinesiophobia, activity limitation and sleep quality; and to compare the groups in regard to patient compliance and treatment satisfaction levels of the groups.

Official Title
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Gebeliğe Bağlı Pelvik Kuşak Ağrısında Pelvik Kemer ve Kinezyo Bant Uygulamalarının Ağrı ve Fonksiyonel Mobilite Üzerine Etkileri

Conditions
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Pelvic Girdle Pain

Intervention / Treatment
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* Other: Kinesio tape (KT)
* Other: Pelvic belt (PB)
* Other: Educational program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being able to read and write in Turkish being in 2nd or 3rd trimester of pregnancy having PGP for more than one week signing the informed consent form for the study Exclusion Criteria: visual, auditory or cognitive problems which may prevent participation to the study health problems other than pregnancy-related PGP (orthopedic, neurologic, cardiorespiratory, etc.) or trauma history, which may affect standing from sitting, walking or stair climbing activities any gynecological or urological problems which may mimic pregnancy related PGP any diagnosed pregnancy complications other than PGP (preeclampsy, hypertension, diabetes,placental/fetal anomaly, preterm labor, etc.) high risk pregnancy (multiple gestation, etc.) history of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology) A positive straight leg raise test result, as well as sensory or motor deficits indicating intervertebral disc pathology history of prepregnancy low back or pelvic girdle pain using any analgesic or myorelaxant medication contraindications to KT or PB (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.) previous KT (abdominal or lumbosacral) or PB experience

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesio tape (KT)<br>Abdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group. | Other: Kinesio tape (KT)<br>* For abdominal taping, four I-shaped tapes will be used. Two of them will start from the superior symphisis pubis, follow the rectus abdominis muscle, and finish at the xiphoid process. Other two I-shaped tapes will start from the mid-symphisis pubis, follow the external oblique abdominals, and finish at the spina iliaca anterior superiors. Symphisis pubis taping will be applied with two I-shaped tapes, by forming a X shape. For lumbopelvic taping, three I-shaped KTs will be used. Two tapes will be applied bilaterally and longitudinally on the lumbar erector spinal muscles. The third tape will start from one sacroiliac joint and end at the other, vertically to the previous two tapes, forming a H-shape. All tapings will be applied with 15-25% tension (tape-off tension). KTs will stay three days. They will be removed from the site, and the skin will be checked and cleaned. Then, they will be reapplied for the next three days.<br>* Other names: elastic tape;Other: Educational program<br>* This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.<br>|
| Active Comparator: Pelvic belt (PB)<br>A narrow and flexible adjustable pelvic belt will be used in high position (just under the spina iliaca anterior superior). This group will also receive the same educational program with the control group. | Other: Pelvic belt (PB)<br>* The women in this group will use the belts, after adjusting them at a comfortable tension, after getting up the bed in the mornings, during daily activities and walking. Evaluation will be made three days after the first application and they will be asked to continue using it for the second three-day period.<br>* Other names: sacroiliac support belt;Other: Educational program<br>* This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.<br>|
| Other: Control group<br>This group will receive a 1-hour educational program composed of neuroscience education and ergonomic training. | Other: Educational program<br>* This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in general pain intensity during activity | The women will be asked to mark their pain intensity during activities in general. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used. | baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| change in pain intensity during five times sit to stand test | The women will be asked to mark their pain intensity during five times sit to stand test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used. | baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| change in pain intensity during five-stairs climbing test | The women will be asked to mark their pain intensity during five-stairs climbing test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used. | baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| change in pain intensity during timed up and go test | The women will be asked to mark their pain intensity during timed up and go test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used. | baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| change in impairment during active straight leg raise test | The women will be asked to score their impairment during active straight leg raise test. 0 (not difficult at all)-5 (unable to do) scoring system will be used. Scores for right and left legs will be summed and recorded. | baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in kinesiophobia | Turkish version of Tampa Kinesiophobia Scale will be used. The score ranges between 17 and 68, and higher score indicates higher kinesiophobia. | baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| change in activity limitation | Turkish version of Pelvic Girdle Questionnaire will be used. Total score varies between 0 and 75, and higher score indicates higher activity limitation. | baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| change in sleep quality | Quality of sleep will be assessed on a 0 (very bad)-10 (very good) cm VAS. | baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| patient compliance | For PB and KT groups, comfort and easiness of using PB and KT will be assessed by 0 (not at all)-10 (extremely comfortable/easy) cm VASs. All groups will be questioned about the comprehensibility of the educational program on 0 (not at all)-10 (completely comprehensible) cm VASs. Also, degree of following the suggestions given in the educational program will be evaluated by 0 (not at all)-10 (completely) cm VASs. | baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 
| treatment satisfaction | Treatment satisfaction will be assessed by 0 (not at all)-10 (extremely satisfactory) cm VASs. | baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kinesio tape, pelvic belt, functional mobility, pain, kinesiophobia, neuroscience education, ergonomic education, activity limitation