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

NCT04139603 | Completed

• 1 other identifier: 47921137-050.01.04-E.109998
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in activity limitation

  baseline, three days after the first taping, and one week after the first taping

Study Arms (3)

Lumbopelvic kinesio taping (LPKT)

ACTIVE COMPARATOR

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.

Other: Lumbopelvic kinesio taping

Abdominal supported lumbopelvic kinesio taping (ALPKT)

EXPERIMENTAL

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.

Other: Abdominal supported lumbopelvic kinesio taping

Placebo taping

PLACEBO COMPARATOR

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

Other: Placebo tapng

Interventions

Lumbopelvic kinesio taping 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.

Also known as: Ergonomic education

Lumbopelvic kinesio taping (LPKT)

Abdominal supported lumbopelvic kinesio taping 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.

Also known as: Ergonomic education

Abdominal supported lumbopelvic kinesio taping (ALPKT)

Placebo tapng 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.

Also known as: Ergonomic education

Placebo taping

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead
• Zeynep Kamil Women's and Children's Diseases Training and Research Hospital: collaborator

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28035911 BACKGROUND

• 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.

  PMID: 29277836 BACKGROUND

• 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.

  PMID: 29303216 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• İlkim Çıtak Karakaya

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 25, 2019
• Study Start: January 27, 2020
• Primary Completion: February 1, 2022
• Study Completion: June 22, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)