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

Lumbopelvic Pain Clinical Trial

Official title:

Gebeliğe Bağlı Lumbopelvik Ağrıda İki Farklı Kinezyo Bant Uygulamasının Ağrı ve Fonksiyonel Mobilite Üzerine Etkisi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139603
• Other study ID #: 47921137-050.01.04-E.109998
• Status: Completed
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: June 22, 2022

Study information

• Verified date: March 2023
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 22, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbopelvic Pain

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Women's and Children's Disease Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University	Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity during resting	0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.	baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Primary	Change in pain intensity during timed up and go (TUG) test	0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.	baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Primary	Change in pain intensity during five times sit to stand test	0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.	baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Primary	Change in pain intensity during stair climbing test	0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.	baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Primary	Change in time of completing timed up and go test (seconds)	All participants will perform the test from a chair (height: 46 cm) with back-support. They will be asked to stand up, walk three meters, turn around, walk back to the chair, and sit down as fast as they can. Time to complete the test will be recorded (sec). Lower times indicate better functional mobility level for walking.	baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Primary	Change in time of completing five times sit to stand test (seconds)	The participants will sit on a straight back chair (43 cm height) with arms folded across their chest. They will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Time for completing the test will be recorded (sec). Lower times indicate better functional mobility level for sit to stand activity.	baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Primary	Change in time of completing stair climbing test (seconds)	The participants will be asked to ascend and descend 10 stairs. Time of completing the test will be recorded in seconds. Lower times indicate better functional mobility level in stair activities	baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Secondary	Change in activity limitation	Turkish version of Pelvic Girdle Questionnaire will be used. Total score of the questionnaire varies between 0 and 75, and higher scores indicate higher activity limitation.	baseline, three days after the first taping, and one week after the first taping