Pregnancy-related Low Back PainNCT05847946
The Effect of Kinesio Taping on Pain and Disability in Pregnancy-Related Low Back Pain
A study testing Kinesio tape application and Core stabilization home program and Core stabilization home program in people with Pregnancy-related Low Back Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Pregnant women may experience pregnancy-related low back pain and this pain may negatively affect function. There are studies in the literature that Kinesiotape applications improve pain. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy-related Low Back Pain
- What is being tested?
- Kinesio tape application and Core stabilization home program and Core stabilization home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2023to 30 Aug 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maternal age between 18 and 40 years, any birth,
- gestational age between 13 and 30 weeks,
- low back pain anywhere from T12 to gluteal fold without leg pain and at least moderate pain intensity (VAS ≥ 4).
Who cannot join
- Known or suspected orthopedic or rheumatological disorders such as scoliosis,
- spinal injuries,
- ankylosing spondylitis or rheumatoid arthritis;
- intervertebral disc pathology;
- a history of low back pain before pregnancy;
- twin pregnancy or fetal anomaly; and any uncontrolled medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kinesio Taping on Pain and Disability in Pregnancy-Related Low Back Pain: A Randomized Clinical Study
Pregnant women may experience pregnancy-related low back pain and this pain may negatively affect function. There are studies in the literature that Kinesiotape applications improve pain. There is no study examining the effect of Kinesiotape application in addition to exercise on pregnancy-related low back pain and function. At the end of our study, we will compare the effects of Kinesiotape application for a total of 8 sessions for 4 weeks on pain and function.
Read the detailed description
Kinesio tape (KT) application is a physiotherapy method whose use has increased in recent years in the treatment of chronic pain. Kinesio tape, an alternative method to support fascia, muscles and joints, Dr. Developed by Kenzo Kase. Although the therapeutic effects of the KT method are still unclear, the putative therapeutic effects include facilitating muscle activity, providing sensory stimuli to the skin, muscles or facial structures, and regulating joint range of motion (ROM) . KT method increases blood and lymph circulation by lifting the skin, and prevents pain by reducing nociceptive stimuli . KT has been administered to pregnancy to improve low back pain. In addition to publications showing that KT can reduce pregnancy-related low back pain, there are studies showing that it has no effect compared to the control group . The aim of this study is to examine the effect of 8 sessions of KT applied in addition to 4-week core stabilization exercises on pain and quality of life in pregnant women with pregnancy-related low back pain.
- Conditions
- Pregnancy-related Low Back Pain
- Being tested
- Kinesio tape application and Core stabilization home program, Core stabilization home program
- Keywords
- Pregnancy, Low back pain, Function, Kinesiologic tape, core stabilization
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tape application and Core stabilization home programOther
Participants in the kinesiotape group will receive 2 sessions of kinesiotape per week, in addition to the core stabilization home program, 5 days a week for 4 weeks.
Core stabilization home programOther
Core stabilization exercises will be given to the participants as a home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape application | Experimental | In addition to core stabilization and pelvic floor exercises, kinesiotape will be applied to the paraspinal muscles in the lumbar region 2 times a week for a total of 8 times. Receives: Other: Kinesio tape application and Core stabilization home program |
| Core stability and pelvic floor exercises group | Active comparator | Participants will perform core stabilization and pelvic floor exercises 5 days a week for 4 weeks. Receives: Other: Core stabilization home program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline pregnancy-related low back Pain at 4 weeks
Pain will be assessed with a 10 cm visual analog scale at night, at rest and during activity. "0" means no pain and "10" means unbearable pain. The assessment will be done before and at the end of the study.
Measured: Baseline and after 4 weeks intervention
Change from Baseline Function at 4 weeks
Function will be assessed with the Oswestry Low Back Pain Disability Questionnaire. The higher the score on the scale, the greater the loss of function. Assessment will be done before and at the end of the study.
Measured: Baseline and after 4 weeks intervention
Secondary outcomes (1)
Change from Baseline Health Quality at 4 weeks
Quality of life will be assessed with the Short Form 36. The higher the score on the scale, the better the quality of life. The assessment will be done before and at the end of the study.
Measured: Baseline and after 4 weeks interventionBaseline and after 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start4 Jun 2023
- Primary completion15 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy-related Low Back 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
- Model description
- Core stability and pelvic floor exercises will be compared with kinesiotape application.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- HASAN GERÇEK, ŞERİFE İREM DÖNER, BAYRAM SÖNMEZ ÜNÜVAR
- Responsible party
- Principal investigator, Hafize Dağ Tüzmen, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847946
- Sponsor's protocol ID
- Kinesio
- Status last verified
- Feb 2024
- First submitted
- 18 Apr 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesio Taping on Pain and Disability in Pregnancy-Related Low Back Pain: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05847946
- Acronym / sponsor ID
- Kinesio
- Conditions
- Pregnancy-related Low Back Pain
- Keywords
- Pregnancy, Low back pain, Function, Kinesiologic tape, core stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- HASAN GERÇEK, ŞERİFE İREM DÖNER, BAYRAM SÖNMEZ ÜNÜVAR
- Study start
- 4 Jun 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 8 May 2023 (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.
Pregnant women may experience pregnancy-related low back pain and this pain may negatively affect function. There are studies in the literature that Kinesiotape applications improve pain. There is no study examining the effect of Kinesiotape application in addition to exercise on pregnancy-related low back pain and function. At the end of our study, we will compare the effects of Kinesiotape application for a total of 8 sessions for 4 weeks on pain and function.
Detailed description
Kinesio tape (KT) application is a physiotherapy method whose use has increased in recent years in the treatment of chronic pain. Kinesio tape, an alternative method to support fascia, muscles and joints, Dr. Developed by Kenzo Kase. Although the therapeutic effects of the KT method are still unclear, the putative therapeutic effects include facilitating muscle activity, providing sensory stimuli to the skin, muscles or facial structures, and regulating joint range of motion (ROM) . KT method increases blood and lymph circulation by lifting the skin, and prevents pain by reducing nociceptive stimuli . KT has been administered to pregnancy to improve low back pain. In addition to publications showing that KT can reduce pregnancy-related low back pain, there are studies showing that it has no effect compared to the control group . The aim of this study is to examine the effect of 8 sessions of KT applied in addition to 4-week core stabilization exercises on pain and quality of life in pregnant women with pregnancy-related low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Core stability and pelvic floor exercises will be compared with kinesiotape application.
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape application | Experimental | Other: Kinesio tape application and Core stabilization home programIn addition to core stabilization and pelvic floor exercises, kinesiotape will be applied to the paraspinal muscles in the lumbar region 2 times a week for a total of 8 times. |
| Core stability and pelvic floor exercises group | Active comparator | Other: Core stabilization home programParticipants will perform core stabilization and pelvic floor exercises 5 days a week for 4 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Maternal age between 18 and 40 years, any birth,
- gestational age between 13 and 30 weeks,
- low back pain anywhere from T12 to gluteal fold without leg pain and at least moderate pain intensity (VAS ≥ 4).
Key exclusion criteria (6 listed)
- Known or suspected orthopedic or rheumatological disorders such as scoliosis,
- spinal injuries,
- ankylosing spondylitis or rheumatoid arthritis;
- intervertebral disc pathology;
- a history of low back pain before pregnancy;
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 application and Core stabilization home programParticipants in the kinesiotape group will receive 2 sessions of kinesiotape per week, in addition to the core stabilization home program, 5 days a week for 4 weeks. | Other | Kinesiotape application |
| Core stabilization home programCore stabilization exercises will be given to the participants as a home exercise program. | Other | Core stability and pelvic floor exercises group |
Primary outcome
Change from Baseline pregnancy-related low back Pain at 4 weeks
Time frame: Baseline and after 4 weeks intervention
Pain will be assessed with a 10 cm visual analog scale at night, at rest and during activity. "0" means no pain and "10" means unbearable pain. The assessment will be done before and at the end of the study.
Change from Baseline Function at 4 weeks
Time frame: Baseline and after 4 weeks intervention
Function will be assessed with the Oswestry Low Back Pain Disability Questionnaire. The higher the score on the scale, the greater the loss of function. Assessment will be done before and at the end of the study.
1 secondary outcome
Change from Baseline Health Quality at 4 weeks
Time frame: Baseline and after 4 weeks interventionBaseline and after 4 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 application and Core stabilization home program and Core stabilization home program in people with Pregnancy-related Low Back Pain, run by KTO Karatay 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 1 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline pregnancy-related low back Pain at 4 weeks (time frame: Baseline and after 4 weeks intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.