Effects of Two Different Kinesio Taping Applications on Pain and Functional Mobility in Pregnants With Lumbopelvic Pain

NCT ID: NCT04139603

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2022-06-22

Brief Summary

This study evaluates and compares the effects of two different kinesio taping applications on pain and functional mobility in pregnancy related lumbopelvic pain.

Detailed Description

Literature studies on the effectiveness of kinesio taping (KT) in pregnancy related lumbopelvic pain (LPP) are limited in number and have methodological shortcomings such as lack of randomization, a control group or assessor and/or patient blindness. Although generally presenting a significant effectiveness of KT on intensity of pain and disability, these parameters are evaluated by subjective methods, and the findings do not rely on quantitative data, in general.

In addition, the intervention parameters used in these studies, such as the KT techniques used, amount of KT tension and duration of the intervention are different from each other, and there is lack of studies comparing the effectiveness of different KT techniques.

In this study, effectiveness of two different KT applications will be compared with placebo KT:

1. Lumbopelvic KT (LPKT): Two I-shaped kinesio tapes in 40 cm length will be applied bilaterally, beginning from 5 cm below the spina iliaca posterior superiors (SIPSs) to the level of the 12th costae, in maximum trunk flexion position, on the paravertebral muscles, by inhibition technique of muscle correction techniques. The tapes will be placed with no tension at 5 cm of both ends, and with 15-25% tension in between. In addition, an extra I-shaped tape will be placed perpendicullar to these tapes with the ligament correction technique, while the pregnant women are in the vertical upright position, at the level of the sacroiliac joints, starting with a tensile strength of 75-100% from the middle, and then with no tension at two ends.

2. Abdominal supported LPKT (ALPKT): An abdominal support tape will be added to the LPKT. In order to reduce the tension of the uterus ligaments, and to help perception of the normal elasticity of the target tissues, ligament technique will be used. The middle part of an I-shaped tape will be placed to the midpoint of the lower abdomen, and then will be progressed laterally and above with 50% tension.

For placebo application, a Micropore™ surgical plaster of the same color with KT will be applied with no tension, as described in the LPKT technique.

All participants will undergo a 45-60 minutes of standard ergonomic education after initial assessments and following the first taping applications, They will be observed in regard to their behaviours during different activities such as standing, sitting, walking, turning in bed and standing from the bed. Necessary warnings will be given about correcting their posture and behaviors in terms of ergonomic principles.

Conditions

Lumbopelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lumbopelvic kinesio taping (LPKT)

Two I-shaped kinesio tapes in 40 cm length will be applied bilaterally, beginning from 5 cm below the spina iliaca posterior superiors (SIPSs) to the level of the 12th costae, in maximum trunk flexion position, on the paravertebral muscles, by inhibition technique of muscle correction techniques. The tapes will be placed with no tension at 5 cm of both ends, and with 15-25% tension in between. In addition, an extra I-shaped tape will be placed perpendicullar to these tapes with the ligament correction technique, while the pregnant women are in the vertical upright position, at the level of the sacroiliac joints, starting with a tensile strength of 75-100% from the middle, and then with no tension at two ends.

Group Type: ACTIVE_COMPARATOR

Lumbopelvic kinesio taping

Intervention Type: OTHER

Kinesio tapes applied to the lumbopelvic region will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.

An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.

Abdominal supported lumbopelvic kinesio taping (ALPKT)

An abdominal support tape will be added to the LPKT. In order to reduce the tension of the uterus ligaments, and to help perception of the normal elasticity of the target tissues, ligament technique will be used. The middle part of an I-shaped tape will be placed to the midpoint of the lower abdomen, and then will be progressed laterally and above with 50% tension.

Group Type: EXPERIMENTAL

Abdominal supported lumbopelvic kinesio taping

Intervention Type: OTHER

Kinesio tapes applied to the lumbopelvic region and abdominal area will stay 3 days. They will be removed from the sites, and the skin will be checked and cleaned, and then reapplied for the next 3 days.

An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.

Placebo taping

A Micropore™ surgical plaster of the same color with KT will be applied with no tension, as described in the LPKT technique.

Group Type: PLACEBO_COMPARATOR

Placebo tapng

Intervention Type: OTHER

Placebo tapes (just like Kinesio tapes) applied to the lumbopelvic region without any tension will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.

An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.

Interventions

Lumbopelvic kinesio taping

Kinesio tapes applied to the lumbopelvic region will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.

An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.

Intervention Type: OTHER

Abdominal supported lumbopelvic kinesio taping

Kinesio tapes applied to the lumbopelvic region and abdominal area will stay 3 days. They will be removed from the sites, and the skin will be checked and cleaned, and then reapplied for the next 3 days.

An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.

Intervention Type: OTHER

Placebo tapng

Placebo tapes (just like Kinesio tapes) applied to the lumbopelvic region without any tension will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.

An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided.

Intervention Type: OTHER

Other Intervention Names

Ergonomic education; Ergonomic education; Ergonomic education

Eligibility Criteria

Inclusion Criteria

• being able to read and write in Turkish,
• being in 2nd or 3rd trimester of pregnancy,
• having lumbar or pelvic girdle pain for at least 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 lumbopelvic pain (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 lumbopelvic pain
• Any ddiagnosed pregnancy complications (preeclampsy, pregnancy related hypertension, diabetes, fetal anomaly, etc.)
• Multiple gestation
• History of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology
• Positive straight leg raising test result or peripheral sensory or motor impairments which may indicate lumbar interbertebral disc pathology
• History of prepregnancy low back pain
• Using any analgesic or myorelaxant medication
• Contraindications to KT (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.)
• previous KT experience

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

UNKNOWN

Sponsor Role: collaborator

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

İlkim Çıtak Karakaya, PT. PhD. Prof.

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlkim Çıtak Karakaya

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Locations

Zeynep Kamil Women's and Children's Disease Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Reyhan AC, Dereli EE, Colak TK. Low back pain during pregnancy and Kinesio tape application. J Back Musculoskelet Rehabil. 2017;30(3):609-613. doi: 10.3233/BMR-160584.

Reference Type: BACKGROUND

PMID: 28035911 (View on PubMed)

Kalinowski P, Krawulska A. Kinesio Taping vs. Placebo in Reducing Pregnancy-Related Low Back Pain: A Cross-Over Study. Med Sci Monit. 2017 Dec 26;23:6114-6120. doi: 10.12659/msm.904766.

Reference Type: BACKGROUND

PMID: 29277836 (View on PubMed)

Kuciel N, Sutkowska E, Cienska A, Markowska D, Wrzosek Z. Impact of Kinesio Taping application on pregnant women suffering from pregnancy-related pelvic girdle pain - preliminary study. Ginekol Pol. 2017;88(11):620-625. doi: 10.5603/GP.a2017.0111.

Reference Type: BACKGROUND

PMID: 29303216 (View on PubMed)

Other Identifiers

47921137-050.01.04-E.109998

Identifier Type: -

Identifier Source: org_study_id