Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain

NCT ID: NCT04266184

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-13
• Study Completion Date: 2022-02-28

Brief Summary

This study investigates the effects of pelvic belt (PB) and kinesio taping (KT) applications on pain and functional mobility in pregnancy-related pelvic girdle pain (PGP), in comparison with the control group that received only pain neuroscience education and ergonomic training.

Detailed Description

Although there is strong evidence in the literature that pelvic support belts reduce pain in pregnancy-related pelvic girdle pain, no study investigating its effect on functional mobility with performance-based measurement methods or investigating its effectiveness on kinesiophobia has been found. Studies investigating the efficacy of KT in pregnant women with PGP are few and many are methodologically weak studies, most of which do not contain randomization and control groups. Also, no study has been found in the literature, which compares the effectiveness of PB and KT in pregnant women with PGP. Therefore, the primary aim of this study is to examine the effects of PB and KT on pain and functional mobility in pregnant women with PGP in comparison with the control group, which is only given pain neuroscience education and ergonomic training. The secondary aims are to investigate the effects of these applications on kinesiophobia, activity limitation and sleep quality; and to compare the groups in regard to patient compliance and treatment satisfaction levels of the groups.

Conditions

Pelvic Girdle Pain

Study Design

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

Study Groups

Kinesio tape (KT)

Abdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group.

Group Type: EXPERIMENTAL

Kinesio tape (KT)

Intervention Type: OTHER

For abdominal taping, four I-shaped tapes will be used. Two of them will start from the superior symphisis pubis, follow the rectus abdominis muscle, and finish at the xiphoid process. Other two I-shaped tapes will start from the mid-symphisis pubis, follow the external oblique abdominals, and finish at the spina iliaca anterior superiors.

Symphisis pubis taping will be applied with two I-shaped tapes, by forming a "X" shape.

For lumbopelvic taping, three I-shaped KTs will be used. Two tapes will be applied bilaterally and longitudinally on the lumbar erector spinal muscles. The third tape will start from one sacroiliac joint and end at the other, vertically to the previous two tapes, forming a H-shape.

All tapings will be applied with 15-25% tension (tape-off tension). KTs will stay three days. They will be removed from the site, and the skin will be checked and cleaned. Then, they will be reapplied for the next three days.

Educational program

Intervention Type: OTHER

This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.

Pelvic belt (PB)

A narrow and flexible adjustable pelvic belt will be used in high position (just under the spina iliaca anterior superior). This group will also receive the same educational program with the control group.

Group Type: ACTIVE_COMPARATOR

Pelvic belt (PB)

Intervention Type: OTHER

The women in this group will use the belts, after adjusting them at a comfortable tension, after getting up the bed in the mornings, during daily activities and walking. Evaluation will be made three days after the first application and they will be asked to continue using it for the second three-day period.

Educational program

Intervention Type: OTHER

This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.

Control group

This group will receive a 1-hour educational program composed of neuroscience education and ergonomic training.

Group Type: OTHER

Educational program

Intervention Type: OTHER

This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.

Interventions

Kinesio tape (KT)

For abdominal taping, four I-shaped tapes will be used. Two of them will start from the superior symphisis pubis, follow the rectus abdominis muscle, and finish at the xiphoid process. Other two I-shaped tapes will start from the mid-symphisis pubis, follow the external oblique abdominals, and finish at the spina iliaca anterior superiors.

Symphisis pubis taping will be applied with two I-shaped tapes, by forming a "X" shape.

For lumbopelvic taping, three I-shaped KTs will be used. Two tapes will be applied bilaterally and longitudinally on the lumbar erector spinal muscles. The third tape will start from one sacroiliac joint and end at the other, vertically to the previous two tapes, forming a H-shape.

All tapings will be applied with 15-25% tension (tape-off tension). KTs will stay three days. They will be removed from the site, and the skin will be checked and cleaned. Then, they will be reapplied for the next three days.

Intervention Type: OTHER

Pelvic belt (PB)

The women in this group will use the belts, after adjusting them at a comfortable tension, after getting up the bed in the mornings, during daily activities and walking. Evaluation will be made three days after the first application and they will be asked to continue using it for the second three-day period.

Intervention Type: OTHER

Educational program

This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.

Intervention Type: OTHER

Other Intervention Names

athletic tape; kinesiology tape; k tape; elastic tape; pelvic compression belt; maternity belt; sacroiliac support belt

Eligibility Criteria

Inclusion Criteria

• being able to read and write in Turkish
• being in 2nd or 3rd trimester of pregnancy
• having PGP for more than 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 PGP (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 PGP
• any diagnosed pregnancy complications other than PGP (preeclampsy, hypertension, diabetes,placental/fetal anomaly, preterm labor, etc.)
• high risk pregnancy (multiple gestation, etc.)
• history of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology)
• A positive straight leg raise test result, as well as sensory or motor deficits indicating intervertebral disc pathology
• history of prepregnancy low back or pelvic girdle pain
• using any analgesic or myorelaxant medication
• contraindications to KT or PB (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.)
• previous KT (abdominal or lumbosacral) or PB experience

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

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

Bezmialem Vakıf University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

İlkim Çıtak Karakaya

Role: CONTACT

ilkim74@yahoo.com

05323611451

Dilan Aydemir

Role: CONTACT

dilanaydemir_@hotmail.com

+905372199221

Facility Contacts

Dilan Aydemir

Role: primary

dilanaydemir_@hotmail.com

+905372199221

References

Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

Reference Type: BACKGROUND

PMID: 22133255 (View on PubMed)

Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.

Reference Type: BACKGROUND

PMID: 29138049 (View on PubMed)

Draper C, Azad A, Littlewood D, Morgan C, Barker L, Weis CA. Taping protocol for two presentations of pregnancy-related back pain: a case series. J Can Chiropr Assoc. 2019 Aug;63(2):111-118.

Reference Type: BACKGROUND

PMID: 31564749 (View on PubMed)

Bertuit J, Van Lint CE, Rooze M, Feipel V. Pregnancy and pelvic girdle pain: Analysis of pelvic belt on pain. J Clin Nurs. 2018 Jan;27(1-2):e129-e137. doi: 10.1111/jocn.13888. Epub 2017 Nov 3.

Reference Type: BACKGROUND

PMID: 28544276 (View on PubMed)

Other Identifiers

47921137-050.01.04-E.144981

Identifier Type: -

Identifier Source: org_study_id