search
Back to results

Effect of Elastic Taping on Stiffness of Lumbar Stabilizer Muscles

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Sham Kinesiotaping
Sponsored by
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istinye UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study group

Control Group

Arm Description

Study group consists of 15 participants, where the elastic kinesiotaping is applied and evaluations are made before and after.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.

Full Information

First Posted
February 14, 2023
Last Updated
May 15, 2023
Sponsor
Istinye University
search

1. Study Identification

Unique Protocol Identification Number
NCT05741645
Brief Title
Effect of Elastic Taping on Stiffness of Lumbar Stabilizer Muscles
Official Title
The Effect of Elastic Banding on the Elasticity of the Lumbar Stabilizer Muscles in Individuals With Non-specific Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
August 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istinye University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Study group consists of 15 participants, where the elastic kinesiotaping is applied and evaluations are made before and after.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Kinesiotaping
Intervention Description
The elastic taping will be randomly applied to a place outside the area to be measured, without stretching, and without causing any effect.
Primary Outcome Measure Information:
Title
muscle stiffness
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The sit and reach test
Description
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.
Time Frame
4 weeks
Title
The functional reach test
Description
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.
Time Frame
4 weeks
Title
Lateral bridge test
Description
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
Time Frame
4 weeks
Title
The Flamingo Test
Description
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.
Time Frame
4 weeks
Title
Back isometric endurance test
Description
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.
Time Frame
4 weeks
Title
Oswestry Disability Index
Description
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.
Time Frame
4 weeks
Title
Visual Analogue Scale
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin Buran Cirak, Prof.
Phone
05435912455
Email
ycirak@istinye.edu.tr
Facility Information:
Facility Name
Istinye University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin Buran Cirak, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Elastic Taping on Stiffness of Lumbar Stabilizer Muscles

We'll reach out to this number within 24 hrs