Back to resultsEffects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain
Primary Purpose
Pelvic Girdle Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape (KT)
Pelvic belt (PB)
Educational program
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Girdle Pain focused on measuring kinesio tape, pelvic belt, functional mobility, pain, kinesiophobia, neuroscience education, ergonomic education, activity limitation
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
Sites / Locations
- Bezmialem Vakıf UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Kinesio tape (KT)
Pelvic belt (PB)
Control group
Arm Description
Abdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group.
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.
This group will receive a 1-hour educational program composed of neuroscience education and ergonomic training.
Outcomes
Primary Outcome Measures
change in general pain intensity during activity
The women will be asked to mark their pain intensity during activities in general. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in pain intensity during five times sit to stand test
The women will be asked to mark their pain intensity during five times sit to stand test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in pain intensity during five-stairs climbing test
The women will be asked to mark their pain intensity during five-stairs climbing test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in pain intensity during timed up and go test
The women will be asked to mark their pain intensity during timed up and go test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in impairment during active straight leg raise test
The women will be asked to score their impairment during active straight leg raise test. 0 (not difficult at all)-5 (unable to do) scoring system will be used. Scores for right and left legs will be summed and recorded.
Secondary Outcome Measures
change in kinesiophobia
Turkish version of Tampa Kinesiophobia Scale will be used. The score ranges between 17 and 68, and higher score indicates higher kinesiophobia.
change in activity limitation
Turkish version of Pelvic Girdle Questionnaire will be used. Total score varies between 0 and 75, and higher score indicates higher activity limitation.
change in sleep quality
Quality of sleep will be assessed on a 0 (very bad)-10 (very good) cm VAS.
patient compliance
For PB and KT groups, comfort and easiness of using PB and KT will be assessed by 0 (not at all)-10 (extremely comfortable/easy) cm VASs. All groups will be questioned about the comprehensibility of the educational program on 0 (not at all)-10 (completely comprehensible) cm VASs. Also, degree of following the suggestions given in the educational program will be evaluated by 0 (not at all)-10 (completely) cm VASs.
treatment satisfaction
Treatment satisfaction will be assessed by 0 (not at all)-10 (extremely satisfactory) cm VASs.
Full Information
NCT ID
NCT04266184
First Posted
February 10, 2020
Last Updated
March 2, 2021
Sponsor
Muğla Sıtkı Koçman University
Collaborators
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04266184
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University
Collaborators
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
Keywords
kinesio tape, pelvic belt, functional mobility, pain, kinesiophobia, neuroscience education, ergonomic education, activity limitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kinesio tape (KT)
Arm Type
Experimental
Arm Description
Abdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group.
Arm Title
Pelvic belt (PB)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
This group will receive a 1-hour educational program composed of neuroscience education and ergonomic training.
Intervention Type
Other
Intervention Name(s)
Kinesio tape (KT)
Other Intervention Name(s)
athletic tape, kinesiology tape, k tape, elastic tape
Intervention Description
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
Intervention Name(s)
Pelvic belt (PB)
Other Intervention Name(s)
pelvic compression belt, maternity belt, sacroiliac support belt
Intervention Description
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
Intervention Name(s)
Educational program
Intervention Description
This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.
Primary Outcome Measure Information:
Title
change in general pain intensity during activity
Description
The women will be asked to mark their pain intensity during activities in general. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
Time Frame
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
Title
change in pain intensity during five times sit to stand test
Description
The women will be asked to mark their pain intensity during five times sit to stand test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
Time Frame
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
Title
change in pain intensity during five-stairs climbing test
Description
The women will be asked to mark their pain intensity during five-stairs climbing test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
Time Frame
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
Title
change in pain intensity during timed up and go test
Description
The women will be asked to mark their pain intensity during timed up and go test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
Time Frame
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
Title
change in impairment during active straight leg raise test
Description
The women will be asked to score their impairment during active straight leg raise test. 0 (not difficult at all)-5 (unable to do) scoring system will be used. Scores for right and left legs will be summed and recorded.
Time Frame
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 Outcome Measure Information:
Title
change in kinesiophobia
Description
Turkish version of Tampa Kinesiophobia Scale will be used. The score ranges between 17 and 68, and higher score indicates higher kinesiophobia.
Time Frame
baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Title
change in activity limitation
Description
Turkish version of Pelvic Girdle Questionnaire will be used. Total score varies between 0 and 75, and higher score indicates higher activity limitation.
Time Frame
baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Title
change in sleep quality
Description
Quality of sleep will be assessed on a 0 (very bad)-10 (very good) cm VAS.
Time Frame
baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Title
patient compliance
Description
For PB and KT groups, comfort and easiness of using PB and KT will be assessed by 0 (not at all)-10 (extremely comfortable/easy) cm VASs. All groups will be questioned about the comprehensibility of the educational program on 0 (not at all)-10 (completely comprehensible) cm VASs. Also, degree of following the suggestions given in the educational program will be evaluated by 0 (not at all)-10 (completely) cm VASs.
Time Frame
baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Title
treatment satisfaction
Description
Treatment satisfaction will be assessed by 0 (not at all)-10 (extremely satisfactory) cm VASs.
Time Frame
baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İlkim Çıtak Karakaya
Phone
05323611451
Email
ilkim74@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dilan Aydemir
Phone
+905372199221
Email
dilanaydemir_@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlkim Çıtak Karakaya
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilan Aydemir
Phone
+905372199221
Email
dilanaydemir_@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22133255
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.
Results Reference
background
PubMed Identifier
29138049
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.
Results Reference
background
PubMed Identifier
31564749
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.
Results Reference
background
PubMed Identifier
28544276
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.
Results Reference
background
Learn more about this trial
Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain
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