- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05741645
Effect of Elastic Taping on Stiffness of Lumbar Stabilizer Muscles
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yasemin Buran Cirak, Prof.
- Phone Number: 05435912455
- Email: ycirak@istinye.edu.tr
Study Locations
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Istanbul, Turkey
- Recruiting
- Istinye University
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Contact:
- Yasemin Buran Cirak, Prof.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Study group consists of 15 participants, where the elastic kinesiotaping is applied and evaluations are made before and after.
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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.
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Sham Comparator: Control Group
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.
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The elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle stiffness
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sit and reach test
Time Frame: 4 weeks
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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.
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4 weeks
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The functional reach test
Time Frame: 4 weeks
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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.
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4 weeks
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Lateral bridge test
Time Frame: 4 weeks
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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
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4 weeks
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The Flamingo Test
Time Frame: 4 weeks
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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.
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4 weeks
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Back isometric endurance test
Time Frame: 4 weeks
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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.
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4 weeks
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Oswestry Disability Index
Time Frame: 4 weeks
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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.
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4 weeks
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Visual Analogue Scale
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-KAEK-120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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