NCT07459231

Brief Summary

The Kinesio Taping® technique and Kinesio Tex® tape were invented by Japanese chiropractor and acupuncturist Dr. in 1973. Developed by 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, pain inhibition, reducing edema, lymphatic drainage and blood flow regulation. It is argued that kinesiology taping, unlike classical taping techniques, provides mechanical support without restricting movement and increases the action mechanism of lymphatic systems and muscle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 4, 2026

Last Update Submit

March 7, 2026

Conditions

Keywords

Laborbirth processKinesio TapingLow Back PainVaginal Birth Self-EfficacyPostpartum ComfortNewborn Apgar Score

Outcome Measures

Primary Outcomes (1)

  • Labor Low Back Pain Intensity

    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: * Active phase of labor (4-8 cm cervical dilation) * Transition phase (8-10 cm cervical dilation) * 5 hours postpartum

    During the active phase of labor (4-8 cm cervical dilatation), transition phase (8-10 cm), and at 5 hours postpartum.

Secondary Outcomes (4)

  • Pain Severity (McGill Melzack Pain Questionnaire Score)

    During active phase of labor (4-8 cm cervical dilatation) and at 5 hours postpartum.

  • Vaginal Childbirth Self-Efficacy

    During active phase of labor (4-8 cm cervical dilatation).

  • Postpartum Comfort Perception

    measured at the fifth hour postpartum

  • Neonatal Apgar Scores

    At 1 and 5 minutes after delivery.

Study Arms (3)

Kinesio Taping Group

EXPERIMENTAL

Application of CE-marked kinesio taping to the lumbar region during active labor.

Device: Kinesio Taping

Placebo Tapping Group

PLACEBO COMPARATOR

Application of non-therapeutic adhesive tape to the lumbar region during active labor.

Device: Placebo Taping

Control Group

NO INTERVENTION

Interventions

Application of elastic therapeutic kinesiology tape to the lumbar region during the active phase of labor in addition to routine obstetric care.

Kinesio Taping Group

Application of non-therapeutic adhesive tape to the lumbar region during the active phase of labor in addition to routine obstetric care.

Placebo Tapping Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe inclusion criteria of the study include only women, provided that they are pregnant.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmır City Hospital

Izmir, Bayrakli, Turkey (Türkiye)

Location

Related Publications (13)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • Kase K. Kinesio taping in pediatrics: Fundamentals and whole-body taping. In: Kase K, Wallis J, Kase T. editors. Newyork: LLC. 2006.

    BACKGROUND
  • Kase K, Wallis J, Kase T. Clinical therapeutic application of the kinesiotaping method. Tokyo, Japan: Ken Ikai Co Ltd; 2003.

    BACKGROUND
  • Cline ME, Herman J, Show F, Marton RD Standardization of the visual analoque scale. Nurs Res.1992; 41(6):378-379.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seyma N Ergun Yilmaz, Degree

    Ege University Institute of Health Sciences

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study was conducted using a single-blind design. Participants were blinded to group allocation to minimize placebo effects and potential bias. Due to the nature of the intervention, the care provider applying the taping and the investigator were not blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a three-arm, parallel-group, randomized controlled clinical investigation. Sample size was calculated using G\*Power 3.1 based on an F test (ANOVA: repeated measures, between factors), assuming a medium effect size (f = 0.50), α = 0.05, and 95% power, yielding a minimum required sample of 45 participants. To account for potential attrition, 60 participants were initially planned. Due to feasibility within the data collection period, 75 participants were enrolled and randomly allocated in a 1:1:1 ratio to Kinesio Taping (n=25), Placebo Taping (n=25), or Control (n=25) groups using computer-generated simple randomization (randomizer.org).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife, MSc Ege University

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

July 20, 2025

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations