Clinical trial NCT04139603: Effects of Two Different Kinesio Taping Applications on Pain and Functional Mobility in Pregnants With Lumbopelvic Pain
Official title: Gebeliğe Bağlı Lumbopelvik Ağrıda İki Farklı Kinezyo Bant Uygulamasının Ağrı ve Fonksiyonel Mobilite Üzerine Etkisi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbopelvic Pain
Keywords: kinesio tape
pain
functional mobility
ergonomic education
pelvic girdle questionnaire
five times sit to stand test
timed up and go test
stair climb test
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
First posted: 2019-10-25
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain intensity during resting
timeFrame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
measure: Change in pain intensity during timed up and go (TUG) test
timeFrame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
measure: Change in pain intensity during five times sit to stand test
timeFrame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
measure: Change in pain intensity during stair climbing test
timeFrame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
measure: Change in time of completing timed up and go test (seconds)
timeFrame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
measure: Change in time of completing five times sit to stand test (seconds)
timeFrame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
measure: Change in time of completing stair climbing test (seconds)
timeFrame: baseline, approximately one-hour after the first taping, three days after the first taping, and one week after the first taping
Secondary outcomes:
measure: Change in activity limitation
timeFrame: baseline, three days after the first taping, and one week after the first taping
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Women's and Children's Disease Training and Research Hospital
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: İlkim Çıtak Karakaya
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.