- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07459231
The Effect of Kinesio Taping During Labor on Low Back Pain, Vaginal Birth Self-Efficacy, Postpartum Comfort Perception, and Newborn Apgar Scores (kinesio tape)
Effect of Kinesio Taping Applied During Labor on Maternal Low Back Pain, Vaginal Birth Self-Efficacy, Postpartum Comfort, and Neonatal Apgar Scores: A Three-Arm Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The kinesio taping technique (The Kinesio Taping® technique) and kinesio tape (Kinesio Tex® tape) were developed in 1973 by Japanese chiropractor and acupuncturist Dr. Kenzo Kase . This method emerged with the idea that good results could be obtained with a taping method that resembles the flexibility and structural properties of the skin without restricting the individual's normal joint movements . The purpose of taping is to reduce pain and improve healing in soft tissues; It has many effects such as increasing proprioception, reducing muscle fatigue, improving muscle function, reducing delayed-onset muscle pain, inhibiting pain, reducing edema, regulating lymphatic drainage and blood flow . It is argued that kinesio taping, unlike classical taping techniques, provides mechanical support without restricting movement and increases the mechanism of action of the lymphatic systems and muscles.
There are 6 different taping techniques developed with increasing experience over the years. These techniques are titled as Mechanical Correction Technique, Fascia Correction Technique, Area Correction Technique, Functional Correction Technique, Ligament Correction Technique, Lymphatic Correction Technique. The application method of the tape is determined according to the desired effect and the muscle type to be applied. The tape has I, Y, X, Fan, Web and Ring (Donut) application methods, while I and Y techniques are preferred if pain and edema are at the forefront. I tape is known as the most preferred taping method especially in acute muscle pain and is thought to reduce pain and edema. Area Correction Technique is applied to leave more space on the painful and inflamed area. Increasing the space area by lifting the skin over the expected area of effect; provides a decrease in the pressure in this area, while the irritation on the chemoreceptors is eliminated and the pain in the area is reduced. As sensory input increases, the gate control mechanism is activated; tension is applied to the middle 1/3 of the I-shaped strip , it is placed in the area where field correction is desired, and the ends of the strip are glued without applying tension. A single strip or strips glued on top of each other can be used.
With the kinesiology taping technique, which has a very large area of effect, especially the musculoskeletal system, different techniques and indications are added every day and the number of studies and investigations on this subject is increasing day by day. Kinesio-tape can also be applied during pregnancy with the protocol defined by Kase. Pain relief is the most important criterion in treatment because pain can seriously affect the pregnant woman. The key to using kinesio tape to relieve pain is how to choose the appropriate position, how to adjust the appropriate tension and how to determine the duration of the adhesive. Since patients and clinicians tend to avoid medications and invasive treatments during pregnancy, kinesio taping offers a new treatment for low back pain during pregnancy as a drug-free and safe alternative treatment. The functional movement and healing effect of the tape is better than physical therapy and does not harm the fetus. In recent years, clinical attention has been drawn to the effect of kinesio taping on low back pain during pregnancy, and relevant studies have been published showing that kinesio taping has a significant effect on low back pain during pregnancy. In a prospective study conducted by Pawel et al. on 106 pregnant women in the third trimester of pregnancy, patients were divided into two groups; 'I' shaped taping was applied to the kinesio-therapy group, additional transverse taping to the same area and abdominal taping to support the abdominal muscles and reduce lumbar load were applied and followed for one week. Pain intensity was followed immediately after taping on the same day, 2 days after taping and on the 5th day, with the kinesio tape removed and the 7th day with VAS pain score and RMDQ (Roland Morris Disability Questionnaire). The control group was taped as placebo. In this study, it was determined that kinesio taping was superior to placebo and its effect continued after the tape was removed. In a study conducted by Xue et al., it was observed that kinesio taping intervention reduced low back pain in the second and third trimesters compared with the control group, and the differences were statistically significant. This suggests that kinesio taping has a positive effect in improving low back pain and low back dysfunction during pregnancy, is superior to other methods including placebos, medications, and other general physical therapy methods, and therefore may serve as a useful therapeutic alternative.
This taping technique, which has been proven to be effective in many areas and has given positive responses in studies on managing back pain during pregnancy, has not been studied in the literature, although it has been proven to relieve back pain in different trimesters of pregnancy. Although labor pain varies from person to person, it is known as a universal symptom of labor. Pain varies according to the stages of labor. While the pain in the first stage of labor is mostly tissue-specific pain caused by uterine contractions and stimulation of the cervix, the pain in the second stage is somatic due to stretching in the vagina and perineum, traction on the uterus and pelvic organs, and distension of the pelvic floor muscles. The pain in the third and fourth stages of labor is tissue-related and traumatic and is caused by expulsion of the placenta and uterine involution. Although the neural mechanism of labor pain is similar to other acute pains, it has many characteristics specific to labor pain. In the first stage of labor, pain is felt in the areas where the uterus and adnexa are located due to mechanical tension in the lower segment of the uterus and dilatation of the cervix, hypoxia and ischemia in the uterus during contraction, pressure and tension in the adnexa, parietal peritoneum and structures surrounding them, bladder, urethra, rectum and pelvis, pressure in the lumbosacral plexus and spasms in the skeletal muscles. The uterus and cervix receive transmission from the sympathetic nerves in the uterine and cervical plexus. Pain receptors are transmitted by small, unmyelinated C fibers. It passes from the lumbar and inferior trochanteric sympathetic chain to the T10-11-12 and L1 nerves. Contraction pain is transmitted by T10-11-12 and L1 fibers and is poorly localized. In the early first stage, a dull pain is felt in the T11-T12 region. As labor progresses, pain gradually intensifies and is transmitted to the abdomen, waist and upper sacral region via the T10-L1 nerves. During this period, pain spreads from the waist to the back and legs, becoming increasingly severe. Research shows that ineffective coping with back pain during labor can cause fatigue, anxiety, stress, prolonged labor, deterioration in the pregnancy-fetus relationship, risk of cesarean section, decreased birth satisfaction, negative thoughts about future births, and early or late postpartum depression. Ineffective coping with back pain during birth reduces the amount of oxygen passing to the fetus, and the rate of hypoxia, distress, perinatal morbidity and mortality in the fetus increases. Therefore, by minimizing back pain during labor, the pregnant woman can actively participate in the birth, the labor process is shortened, the mother and baby interaction after birth is stronger, and it helps to reduce anxiety about birth and increase the comfort level. With the use of the kinesio taping method for back pain felt during birth; pain relief, experiencing labor as a more comfortable and relaxed process, and positive effects on the health of the newborn can be observed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bayrakli
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Izmir, Bayrakli, Turkey (Türkiye)
- Izmır City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Women aged 18-45 years
- Singleton pregnancy
- Gestational age between 37-40 weeks
- In the active phase of labor (≥4 cm cervical dilation)
- Experiencing low back pain during labor
- No previous diagnosed lumbar spine disease
- No dermatological condition preventing kinesio or placebo taping
- Able and willing to provide written informed consent
Exclusion Criteria
- Multiple pregnancy
- Cesarean delivery
- Pharmacological induction during labor (e.g., prostaglandins or oxytocin)
- Displacement or removal of the applied tape during labor
- Infection, sensory loss, or skin lesion at the taping site
- Allergy to kinesio tape or adhesive materials
- Withdrawal of consent at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Kinesio Taping Group
Application of CE-marked kinesio taping to the lumbar region during active labor.
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Application of elastic therapeutic kinesiology tape to the lumbar region during the active phase of labor in addition to routine obstetric care.
|
|
Placebo Comparator: Placebo Tapping Group
Application of non-therapeutic adhesive tape to the lumbar region during active labor.
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Application of non-therapeutic adhesive tape to the lumbar region during the active phase of labor in addition to routine obstetric care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Labor Low Back Pain Intensity
Time Frame: During the active phase of labor (4-8 cm cervical dilatation), transition phase (8-10 cm), and at 5 hours postpartum.
|
Low back pain intensity measured using the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Pain will be measured at three time points:
|
During the active phase of labor (4-8 cm cervical dilatation), transition phase (8-10 cm), and at 5 hours postpartum.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Severity (McGill Melzack Pain Questionnaire Score)
Time Frame: During active phase of labor (4-8 cm cervical dilatation) and at 5 hours postpartum.
|
Pain severity assessed using the McGill Melzack Pain Questionnaire (MPQ), a validated multidimensional instrument measuring sensory and affective dimensions of pain.
The questionnaire was administered during the active phase of labor and at 5 hours postpartum.
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During active phase of labor (4-8 cm cervical dilatation) and at 5 hours postpartum.
|
|
Vaginal Childbirth Self-Efficacy
Time Frame: During active phase of labor (4-8 cm cervical dilatation).
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Childbirth self-efficacy assessed using the validated Vaginal Childbirth Self-Efficacy Scale, measuring the woman's confidence in coping with labor and birth.
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During active phase of labor (4-8 cm cervical dilatation).
|
|
Postpartum Comfort Perception
Time Frame: measured at the fifth hour postpartum
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Postpartum comfort perception assessed using the validated Postpartum Comfort Scale.
|
measured at the fifth hour postpartum
|
|
Neonatal Apgar Scores
Time Frame: At 1 and 5 minutes after delivery.
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Neonatal well-being assessed using Apgar scores evaluated at 1 and 5 minutes after birth.
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At 1 and 5 minutes after delivery.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seyma N Ergun Yilmaz, Degree, Ege University Institute of Health Sciences
- Study Director: Zehra Baykal Akmese, Assoc.Prof.Dr., Ege University Institute of Health Sciences
- Study Director: Yasam K Akpak, Assoc.Prof.Dr., Izmir City Hospital, Department of Obstetrics and Gynecology University of Health Sciences, İzmir Faculty of Medicine, Department of Obstetrics and Gynecology
- Study Director: Mehmet Ozkeskin, Assoc.Prof.Dr., Ege University Faculty of Health Sciences
Publications and helpful links
General Publications
- Jaron A, Konkol B, Gabrysz-Trybek E, Bladowska J, Grzywacz A, Nedjat A, Trybek G. Kinesio taping in various fields of medicine, dentistry, sport and physiotherapy. Balt J Health Phys Act. 2021, 13(2), 11-25. Doi: 10.29359/BJHPA.13.2.02
- Gutke A, Betten C, Degerskär K, Pousette S, Olsén MF. Treatments for pregnancy-related lumbopelvic pain: A systematic review of physiotherapy modalities. Acta Obstet Gynecol Scand. 2015, 94(11), 1156-67. Doi: 10.1111/aogs.12681
- Kalinowski P, Krawulska A. Kinesio taping vs. placebo in reducing pregnancy-related low back pain: A cross-over study. Medical Science Monitor, 2017, 23, 6114-6120. Doi:10.12659/Msm.904766
- Xue X, Chen Y, Mao X, Tu H, Yang X, Deng Z, Li N. Effect of kinesio taping on low back pain during pregnancy: A systematic review and meta-analysis. BMC Pregnancy and Childbirth, 2021, 21(1), 712. Doi: 10.1186/S12884-021-04197-3
- Uysal, C., İlkay, B. O. Z., & SALMAN, S. (2022). Doğum Eyleminin Aktif Fazında Yaşanan Bel Ağrısının Yönetiminde Steril Su Enjeksiyonunun Etkisi: Randomize, Plasebo Kontrollü Bir Çalışma. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 15(2), 163-174.
- Kase K. Kinesio taping in pediatrics: Fundamentals and whole-body taping. In: Kase K, Wallis J, Kase T. editors. Newyork: LLC. 2006.
- Kase K, Wallis J, Kase T. Clinical therapeutic application of the kinesiotaping method. Tokyo, Japan: Ken Ikai Co Ltd; 2003.
- Cline ME, Herman J, Show F, Marton RD Standardization of the visual analoque scale. Nurs Res.1992; 41(6):378-379.
- Chu, K.H., Chen, A.C., Tai, C.J., Chen, S.H., Chien, L.Y. (2017). Development and validation of the selfefficacy regarding vaginal birth scale. JOGNN, 46, e13-e2
- Chinchilla-Ochoa D, Peón PBC, FarfánLabonne BE, Garza-Morales S, LeffGelman P, Flores-Ramos M. Depressive symptoms in pregnant women with high trait and state anxiety during pregnancy and postpartum. International Journal of Women's Health 2019; 11:257
- Açıkyol T., Lumbar disk hernisi olan hastalarda kinezyo bantlama ve manuel terapi etkilerinin karşılaştırılması, Hasan Kalyoncu Ünı̇versı̇tesı̇ Sağlık Bı̇lı̇mlerı̇ Enstı̇tüsü, Gaziantep, 2020, Yüksek Lisans Tezi
- Baykal, Z. (2008). Bel ağrısı olan gebelerde progresif gevşeme egzersizlerinin ağrı algısına ve yaşam kalitesi üzerine etkisi. Ege Üniversitesi Sağlık Bilimleri Enstitüsü, Yüksek Lisans Tezi, İzmir.
- Biz C, Nicoletti P, Tomasin M, Bragazzi NL, Di Rubbo G, Ruggieri P. Is kinesio taping effective for sport performance and ankle function of athletes with chronic ankle ınstability (CAI) A systematic review and meta-analysis. Medicina (Kaunas, Lithuania), 2022, 58(5), 620. Doi:10.3390/Medicina58050620
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGE-SBE-SEY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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