Low Back PainNCT05741645
Effect of Elastic Taping on Stiffness of Lumbar Stabilizer Muscles
A study testing Kinesiotaping in people with Low Back Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime. Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Kinesiotaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2023to 1 Apr 2025
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who diagnosed with non-specific low back pain
- between the ages of 18-24
- patients who able to perform at least 40° of trunk flexion
Who cannot join
- patients who obese, pregnant, had specific low back pain
- indication for surgery in the past 1 year
- the trauma of lumbar region, and systemic inflammatory disease affecting this area
- exercise and conventional physiotherapy in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Elastic Banding on the Elasticity of the Lumbar Stabilizer Muscles in Individuals With Non-specific Low Back Pain.
Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime.
Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Chronic low back pain ranks second among the most common pain complaints under the age of 45 in the industrial age of limited activity. Organic pathology is not encountered in most musculoskeletal system pains. There are usually many underlying causes. The current literature offers a variety of treatment options, depending on the duration and severity of the symptoms of non-specific low back pain. These treatments include behavioral cognitive therapy, medication, electrophysical agents, manual therapy, and general exercises. Looking at the literature, it has been observed that there are not many objective studies investigating the effect of elastic bandage application on muscle elasticity.
'Shear Wave Elastography' is a method that quantitatively reveals the elasticity of tissues by measuring the speed of shear waves formed in the tissues through non-invasive high-frequency ultrasound waves. In recent studies, Shear Wave Elastography has shown promising results in demonstrating the elasticity of peripheral nerves.
- Conditions
- Low Back Pain
- Being tested
- Kinesiotaping, Sham Kinesiotaping
- 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.
KinesiotapingOther
During the kinesio taping of the erector spina vs multifidus muscles, the patient is in a standing position. Kinesiotape is applied with 50% tension and stays in the patient for 30 minutes.
Sham KinesiotapingOther
The elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Study group consists of 15 participants, where the elastic kinesiotaping is applied and evaluations are made before and after. Receives: Other: Kinesiotaping |
| Control Group | Sham comparator | To the participants in the control group, the elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect. Receives: Other: Sham Kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle stiffness
The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.
Measured: 4 weeks
Secondary outcomes (7)
The sit and reach test
The test is administered using the sit-and-reach test box. Subjects are seated on flat ground. The soles of both feet are flat on the test bench and the knees are asked to maintain contact with the ground in full extension. Participants are asked to reach forward on the measurement line with their palms facing down and hands on top of each other, and wait for a second or two at the last point they can reach with their hands; After three attempts, the best score is recorded. Foot level is considered 0, measurements that do not reach foot level are recorded as negative and values exceeding foot level are recorded as positive.
Measured: 4 weeks
The functional reach test
It is applied to measure the functional balance of the individual and the amount of dynamic reach. Individuals are asked to reach as far as they can without their heels off the ground and without hip flexion.
Measured: 4 weeks
Lateral bridge test
The participant lying on his/her non-dominant side will be asked to form a support surface from the elbow with the arm below, to place the other hand on the waist, and to build a bridge by raising the hip and knee. The time the balance is maintained will be recorded
Measured: 4 weeks
The Flamingo Test
According to this test, the research group; 50 cm. in length, 4 cm. in height and 3 cm. Patient stands in balance by stepping on a wooden balance beam with his dominant foot. Bend the other foot at the knee and pull it towards the hip, holding it with the hand on the same side. While the research group is in balance with one leg in this way, the time starts and they try to stay balanced in this way for 1 minute. When the balance is disturbed (if he leaves while holding his foot, falls from the board, touches the ground with any part of his body, etc.), the time-time is stopped. When the research group regains its balance by climbing on the balance beam, the time continues from where it left off. The test continues in this way for one minute. When the time is up, each attempt to balance (after falling) by the research group is counted, and this number is recorded as the research group's score when the one minute time is up at the end of the test.
Measured: 4 weeks
Back isometric endurance test
For this test, the participant is placed in a prone position with the torso hanging from the bed from the anterior superior iliac spine. The athlete is asked to keep his body parallel to the ground against gravity, with the legs fixed at the level of the gastrocnemius muscle and the hands clasped on the chest. Partial trunk extension is allowed. When the posture is disturbed and/or the athlete quits the experiment due to fatigue and pain, the time is stopped and the score in seconds is recorded.
Measured: 4 weeks
Oswestry Disability Index
It consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, traveling and the degree of pain. Each item is graded between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points; It is evaluated as heavy between 31-50 points, moderate between 11-30 points and mild between 1-10 points. The percentage of disability can be calculated by converting the total score obtained from the patient to the percentage system.
Measured: 4 weeks
Visual Analogue Scale
Pain will be measured with a Visual Analogue Scale (VAS). VAS is the most commonly used method for measuring pain level. The score range is from 0 to 10. 0 points indicates no pain, 10 points unbearable pain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start20 Jun 2023
- Primary completion20 Jun 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Koce, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741645
- Sponsor's protocol ID
- 2017-KAEK-120
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2023
- Last updated
- 15 Apr 2025
- Results posted
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Elastic Banding on the Elasticity of the Lumbar Stabilizer Muscles in Individuals With Non-specific Low Back Pain.
- ClinicalTrials.gov ID
- NCT05741645
- Acronym / sponsor ID
- 2017-KAEK-120
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 23 Feb 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.
Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime.
Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Chronic low back pain ranks second among the most common pain complaints under the age of 45 in the industrial age of limited activity. Organic pathology is not encountered in most musculoskeletal system pains. There are usually many underlying causes. The current literature offers a variety of treatment options, depending on the duration and severity of the symptoms of non-specific low back pain. These treatments include behavioral cognitive therapy, medication, electrophysical agents, manual therapy, and general exercises. Looking at the literature, it has been observed that there are not many objective studies investigating the effect of elastic bandage application on muscle elasticity.
'Shear Wave Elastography' is a method that quantitatively reveals the elasticity of tissues by measuring the speed of shear waves formed in the tissues through non-invasive high-frequency ultrasound waves. In recent studies, Shear Wave Elastography has shown promising results in demonstrating the elasticity of peripheral nerves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: KinesiotapingStudy group consists of 15 participants, where the elastic kinesiotaping is applied and evaluations are made before and after. |
| Control Group | Sham comparator | Other: Sham KinesiotapingTo the participants in the control group, the elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients who diagnosed with non-specific low back pain
- between the ages of 18-24
- patients who able to perform at least 40° of trunk flexion
Key exclusion criteria (4 listed)
- patients who obese, pregnant, had specific low back pain
- indication for surgery in the past 1 year
- the trauma of lumbar region, and systemic inflammatory disease affecting this area
- exercise and conventional physiotherapy in the last 6 months
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 |
|---|---|---|
| KinesiotapingDuring the kinesio taping of the erector spina vs multifidus muscles, the patient is in a standing position. Kinesiotape is applied with 50% tension and stays in the patient for 30 minutes. | Other | Study group |
| Sham KinesiotapingThe elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect. | Other | Control Group |
Primary outcome
muscle stiffness
Time frame: 4 weeks
The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.
7 secondary outcomes
The sit and reach test
Time frame: 4 weeks
The functional reach test
Time frame: 4 weeks
Lateral bridge test
Time frame: 4 weeks
The Flamingo Test
Time frame: 4 weeks
Back isometric endurance test
Time frame: 4 weeks
Oswestry Disability Index
Time frame: 4 weeks
Visual Analogue Scale
Time frame: 4 weeks
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 15 Apr 2025.
- 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 Kinesiotaping in people with Low Back Pain, run by Istinye 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 4 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 15 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
muscle stiffness (time frame: 4 weeks). 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 15 Apr 2025.