Pelvic Girdle PainNCT04266184
Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain
A study testing Kinesio tape (KT), Pelvic belt (PB) and Educational program in people with Pelvic Girdle Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- Kinesio tape (KT), Pelvic belt (PB) and Educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2020to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf University
Istanbul
Dilan Aydemir, +905372199221, dilanaydemir_@hotmail.com
About this study
Official title: Gebeliğe Bağlı Pelvik Kuşak Ağrısında Pelvik Kemer ve Kinezyo Bant Uygulamalarının Ağrı ve Fonksiyonel Mobilite Üzerine Etkileri
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.
Read the 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
- Being tested
- Kinesio tape (KT), Pelvic belt (PB), Educational program
- Keywords
- kinesio tape, pelvic belt, functional mobility, pain, kinesiophobia, neuroscience education, ergonomic education, activity limitation
- Medical subject headings
- Pelvic Girdle Pain, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tape (KT)Other
Also called athletic tape, kinesiology tape, k tape, elastic tape
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.
Pelvic belt (PB)Other
Also called pelvic compression belt, maternity belt, sacroiliac support belt
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 programOther
This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio tape (KT) | Experimental | Abdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group. Receives: Other: Kinesio tape (KT); Other: Educational program |
| Pelvic belt (PB) | Active comparator | 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. Receives: Other: Pelvic belt (PB); Other: Educational program |
| Control group | Other | This group will receive a 1-hour educational program composed of neuroscience education and ergonomic training. Receives: Other: Educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 (5)
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.
Measured: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
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.
Measured: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
change in sleep quality
Quality of sleep will be assessed on a 0 (very bad)-10 (very good) cm VAS.
Measured: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
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.
Measured: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
treatment satisfaction
Treatment satisfaction will be assessed by 0 (not at all)-10 (extremely satisfactory) cm VASs.
Measured: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start13 Mar 2020
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, İlkim Çıtak Karakaya, PT. PhD. Prof., Muğla Sıtkı Koçman University
- Investigators
- İlkim Çıtak Karakaya, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266184
- Sponsor's protocol ID
- 47921137-050.01.04-E.144981
- Status last verified
- Mar 2021
- First submitted
- 10 Feb 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22133255Bodes 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.
PubMed 29138049Draper 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.
PubMed 31564749Bertuit 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.
PubMed 28544276
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gebeliğe Bağlı Pelvik Kuşak Ağrısında Pelvik Kemer ve Kinezyo Bant Uygulamalarının Ağrı ve Fonksiyonel Mobilite Üzerine Etkileri
- ClinicalTrials.gov ID
- NCT04266184
- Acronym / sponsor ID
- 47921137-050.01.04-E.144981
- Conditions
- Pelvic Girdle Pain
- Keywords
- kinesio tape, pelvic belt, functional mobility, pain, kinesiophobia, neuroscience education, ergonomic education, activity limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio tape (KT) | Experimental | Other: Kinesio tape (KT), Other: Educational programAbdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group. |
| Pelvic belt (PB) | Active comparator | Other: Pelvic belt (PB), Other: Educational programA 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. |
| Control group | Other | Other: Educational programThis group will receive a 1-hour educational program composed of neuroscience education and ergonomic training. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tape (KT)Also: athletic tape, kinesiology tape, k tape, elastic tapeFor 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. | Other | Kinesio tape (KT) |
| Pelvic belt (PB)Also: pelvic compression belt, maternity belt, sacroiliac support beltThe 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. | Other | Pelvic belt (PB) |
| Educational programThis program will include pain neuroscience education and ergonomic education, and will approximately last one hour. | Other | Control group, Kinesio tape (KT), Pelvic belt (PB) |
Primary outcome
change in general pain intensity during activity
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
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
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
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
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
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
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
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
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
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.
5 secondary outcomes
change in kinesiophobia
Time frame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
change in activity limitation
Time frame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
change in sleep quality
Time frame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
patient compliance
Time frame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
treatment satisfaction
Time frame: baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 22133255Louw 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.
- Background: PubMed 29138049Bodes 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.
- Background: PubMed 31564749Draper 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.
- Background: PubMed 28544276Bertuit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlkim Çıtak Karakaya principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape (KT), Pelvic belt (PB) and Educational program in people with Pelvic Girdle Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İlkim Çıtak Karakaya (05323611451, ilkim74@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in general pain intensity during activity (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266184, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.