Clinical trial NCT04266184: Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain
Official title: Gebeliğe Bağlı Pelvik Kuşak Ağrısında Pelvik Kemer ve Kinezyo Bant Uygulamalarının Ağrı ve Fonksiyonel Mobilite Üzerine Etkileri
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Girdle Pain
Keywords: kinesio tape
pelvic belt
functional mobility
pain
kinesiophobia
neuroscience education
ergonomic education
activity limitation
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2020-02-12
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in general pain intensity during activity
timeFrame: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: change in pain intensity during five times sit to stand test
timeFrame: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: change in pain intensity during five-stairs climbing test
timeFrame: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: change in pain intensity during timed up and go test
timeFrame: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: change in impairment during active straight leg raise test
timeFrame: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Secondary outcomes:
measure: change in kinesiophobia
timeFrame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: change in activity limitation
timeFrame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: change in sleep quality
timeFrame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: patient compliance
timeFrame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
measure: treatment satisfaction
timeFrame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: İlkim Çıtak Karakaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.