Low Back PainNCT05319184
Acute Effect of Myofascial Release and Kinesiology Taping
A study testing Myofascial Release Technique and Kinesiology Taping in people with Low Back Pain and Kinesio Taping, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Chronic low back pain (LBP) is one of the leading causes of activity limitation and disability. The prevalence of chronic CBA among young adults is known to increase, and a recent epidemiological study reported a rate of 42.4% per year among young adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Kinesio Taping, Myofascial Release Technique
- What is being tested?
- Myofascial Release Technique and Kinesiology Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2023to 15 Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-45
- Being diagnosed with nonspecific chronic low back pain (lasting longer than 3 months)
- Volunteering to participate in the study
Who cannot join
- Those who have had major surgery or trauma related to the musculoskeletal system, especially the lumbar region
- Those with neurological disease
- Those with rheumatic disease in the active period
- Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
- Those with serious psychological problems (BDI score of 30 and above)
- Those with kinesiology tape allergies
Show all 10Show fewer
- Those with contraindications to myofascial release therapy (acute inflammations, viral and bacterial infections, infectious diseases, fever, deep vein thrombosis, active malignant disease, aneurysms)
- Those who received physiotherapeutic intervention to the lumbar region in the last 6 months
- Obesity (BMI≥30 kg/m2)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Myofascial Release and Kinesiology Taping on Parameters Associated With Chronic Low Back Pain
Chronic low back pain (LBP) is one of the leading causes of activity limitation and disability. The prevalence of chronic CBA among young adults is known to increase, and a recent epidemiological study reported a rate of 42.4% per year among young adults. Studies show that changes in the paravertebral muscles have an important relationship with the formation of Chronic LBP, and therefore, evaluation of the mechanical properties of the paravertebral muscles is of great importance for the clinical diagnosis and treatment of Chronic LBP.
Mechanical properties of the muscle, such as muscle stiffness and tone, are considered essential for maintaining efficient muscle contraction. Abnormally high muscle tone blocks blood flow, leading to faster muscle fatigue and slower muscle recovery. When there is abnormally high muscle stiffness, stretching the stiffened antagonist muscles requires more effort, resulting in lower exercise efficiency. Muscle stiffness is one of the critical indicators of energy storage of the muscle-tendon unit, which has a significant effect on the control of joint movement. Altered tone and stiffness in the lumbar myofascial region have been described in association with underlying pathologies and symptoms in people with Chronic LBP. Rehabilitation interventions such as manual therapy or therapeutic exercises are common techniques for the treatment of chronic Chronic LBP because of their benefits in altering muscle tone and stiffness by reducing paraspinal muscle activity.
Although the effectiveness of the myofascial release technique in individuals with Chronic LBP is supported in the literature, the long-term use of the therapist's hand support creates difficulties in practice in the clinical setting. The KT technique, on the other hand, seems to be a method that can be used as an alternative to myofascial release technique in the treatment of Chronic LBP, since it is an easy-to-use and time-consuming approach. When the studies conducted to date are examined, no study has been found that compares the effectiveness of myofascial release and kinesiology taping applied to individuals with Chronic LBP. The aim of our study is to compare the acute effect of myofascial release and kinesiology taping in individuals with Chronic LBP.
- Conditions
- Low Back Pain, Kinesio Taping, Myofascial Release Technique
- Being tested
- Myofascial Release Technique and Kinesiology Taping
- Keywords
- Low Back Pain, Kinesio Taping, Myofascial release technique
- 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.
Myofascial Release Technique and Kinesiology TapingOther
Myofascial release is a manual release technique that increases the elasticity and glide between soft tissue layers, reduces this increased muscle activity and pain intensity. Myofascial release is usually characterized by prolonged mechanical forces exerted directly or indirectly on the limited fascial layers with low load. Following the direction of the fascial restraint, the therapist's hands slowly maintain the stretch and allow the fascia to relax on its own.
Kinesio Taping is a non-invasive, painless and less time consuming method with fewer side effects. It is an elastic-cotton adhesive tape that is latex-free and can be used on any joint or muscle. It can stretch significantly (130-140% of its original length), which reduces mechanical movement limitations and mimics skin in thickness and elasticity. It is used in the treatment of LBP to reduce muscle tone and stiffness as a rehabilitative taping technique designed to support the body's natural healing process.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release Group | Experimental | The application will be made with the patient in the prone position. By applying a few grams of constant force to the lumbar paravertebral muscles bilaterally with the hand of the physiotherapist in the direction of restriction for 3-5 minutes, the fascia will be stretched and allow the tissue to relax on its own. Thus, it is aimed to decrease the tone and stiffness of the paravertebral muscles. Receives: Other: Myofascial Release Technique and Kinesiology Taping |
| Kinesiology Taping Group | Experimental | During the application, the participants will be positioned standing and facing backwards due to the ease of application. While taping the lumbar region, the kinesiology tape cut as a long strip (I tape) will be applied paravertebrally to the right and left sides of the spine. Rounded corners will be created to prevent premature loosening and unwanted bends in the belt. The patient will be asked to perform maximum trunk flexion and 2 I-shaped pieces will be taped with 10-15% tension from the lumbar region to the thoracic region. The tape will remain on the patient's skin for 30 minutes. Receives: Other: Myofascial Release Technique and Kinesiology Taping |
| Control Group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Tone and Stiffness
Muscle tone and stiffness will be evaluated with a myotonometer. The myotonusometer was developed for the objective measurement of mechanical muscle properties. Myotonusometry reflects the viscoelastic properties of the muscle such as tone and stiffness by creating oscillation in the muscle fiber and is an acceptable and reliable method for measuring the mechanical properties of the muscle in young adults with chronic LBP. The device measures muscle tone as the natural oscillation frequency (Hz) calculated as Hz = 1/T; where T is the oscillation time measured in seconds. Muscle stiffness (N/m) is related to the maximum acceleration of oscillation and tissue deformation recorded by the transducer.
Measured: 4 weeks
Visual Analogue Scale
The Visual Analog Scale is a simple, precise and reproducible tool that is often used to assess pain severity. Due to its easy application, it is one of the most frequently used measurement tools to measure the severity of pain in low back pain. It consists of a horizontal or vertical line ten cm long. The starting point of the line, '0', represents no pain, and the ending point, '10', represents the most severe pain imaginable. Pain intensity increases as you go from 0 to 10. The patient is asked to mark the severity of the pain on the line, the point marked by the patient is recorded in cm.
Measured: 4 weeks
Joint Range of Motion
Lumbar region flexion, extension, lateral flexion and rotation movements will be measured bilaterally with a digital goniometer. Measurements will be repeated 3 times and the average value will be recorded in degrees.
Measured: 4 weeks
Secondary outcomes (3)
Mobility
The Modified Schober Test will be used to evaluate the mobility of the lumbar region. For this test, while the patient is standing, mark 10 cm upwards from the second sacral spinous process and 5 cm downwards from this protrusion (the distance between the two points is 15 cm). The patient has maximum flexion of the trunk and the distance between the two points is measured. The difference is found by subtracting 15 cm (the distance between two points in upright posture) from the value found. The fact that this difference is less than 5 cm indicates that the mobility of the lumbar region is reduced.
Measured: 4 weeks
Progressive İsoinartial Lifting Evaluation
The PILE Test will be used to evaluate the general body strength and endurance of the participants. Application of the test: The test starts with a weight of 3.6 kg for women and 5.9 kg for men. These weights are put into the box and the participants are asked to lift this box to a 75 cm high table 4 times within 20 seconds. After each completed lap, a weight of 2.25 kg for women and 4.5 kg for men is added to the box. If the participant fails to complete 4 repetitions within 20 seconds, wishes to discontinue the test due to fatigue or extreme discomfort (psychophysical endpoint), reaches 85% of maximum heart rate (220-years), or reaches the maximum weight that can be safely lifted (55-60% of body weight) i) the test is terminated. The maximum weight lifted and the number of repetitions are recorded. By multiplying the maximum weight lifted and the number of repetitions, the total work done is calculated and recorded.
Measured: 4 weeks
1 Minute Stepping Test
The step test will be used to evaluate the physical performance of the participants. During the test, participants will be asked to go up and down a step of 40 cm for 1 minute. The number of repetitions performed in 1 minute will be recorded for the right and left sides.
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 posted8 Apr 2022
- Study start30 Jun 2023
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
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 Istanbul University - CerrahpasaThe 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
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Kardes, MSc PT, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319184
- Sponsor's protocol ID
- 003
- Status last verified
- Sep 2023
- First submitted
- 31 Mar 2022
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Myofascial Release and Kinesiology Taping on Parameters Associated With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05319184
- Acronym / sponsor ID
- 003
- Conditions
- Low Back Pain, Kinesio Taping, Myofascial Release Technique
- Keywords
- Low Back Pain, Kinesio Taping, Myofascial release technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 8 Apr 2022 (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.
Chronic low back pain (LBP) is one of the leading causes of activity limitation and disability. The prevalence of chronic CBA among young adults is known to increase, and a recent epidemiological study reported a rate of 42.4% per year among young adults. Studies show that changes in the paravertebral muscles have an important relationship with the formation of Chronic LBP, and therefore, evaluation of the mechanical properties of the paravertebral muscles is of great importance for the clinical diagnosis and treatment of Chronic LBP.
Mechanical properties of the muscle, such as muscle stiffness and tone, are considered essential for maintaining efficient muscle contraction. Abnormally high muscle tone blocks blood flow, leading to faster muscle fatigue and slower muscle recovery. When there is abnormally high muscle stiffness, stretching the stiffened antagonist muscles requires more effort, resulting in lower exercise efficiency. Muscle stiffness is one of the critical indicators of energy storage of the muscle-tendon unit, which has a significant effect on the control of joint movement. Altered tone and stiffness in the lumbar myofascial region have been described in association with underlying pathologies and symptoms in people with Chronic LBP. Rehabilitation interventions such as manual therapy or therapeutic exercises are common techniques for the treatment of chronic Chronic LBP because of their benefits in altering muscle tone and stiffness by reducing paraspinal muscle activity.
Although the effectiveness of the myofascial release technique in individuals with Chronic LBP is supported in the literature, the long-term use of the therapist's hand support creates difficulties in practice in the clinical setting. The KT technique, on the other hand, seems to be a method that can be used as an alternative to myofascial release technique in the treatment of Chronic LBP, since it is an easy-to-use and time-consuming approach. When the studies conducted to date are examined, no study has been found that compares the effectiveness of myofascial release and kinesiology taping applied to individuals with Chronic LBP. The aim of our study is to compare the acute effect of myofascial release and kinesiology taping in individuals with Chronic LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release Group | Experimental | Other: Myofascial Release Technique and Kinesiology TapingThe application will be made with the patient in the prone position. By applying a few grams of constant force to the lumbar paravertebral muscles bilaterally with the hand of the physiotherapist in the direction of restriction for 3-5 minutes, the fascia will be stretched and allow the tissue to relax on its own. Thus, it is aimed to decrease the tone and stiffness of the paravertebral muscles. |
| Kinesiology Taping Group | Experimental | Other: Myofascial Release Technique and Kinesiology TapingDuring the application, the participants will be positioned standing and facing backwards due to the ease of application. While taping the lumbar region, the kinesiology tape cut as a long strip (I tape) will be applied paravertebrally to the right and left sides of the spine. Rounded corners will be created to prevent premature loosening and unwanted bends in the belt. The patient will be asked to perform maximum trunk flexion and 2 I-shaped pieces will be taped with 10-15% tension from the lumbar region to the thoracic region. The tape will remain on the patient's skin for 30 minutes. |
| Control Group | No intervention | –No intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-45
- Being diagnosed with nonspecific chronic low back pain (lasting longer than 3 months)
- Volunteering to participate in the study
Key exclusion criteria (10 listed)
- Those who have had major surgery or trauma related to the musculoskeletal system, especially the lumbar region
- Those with neurological disease
- Those with rheumatic disease in the active period
- Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
- Those with serious psychological problems (BDI score of 30 and above)
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 |
|---|---|---|
| Myofascial Release Technique and Kinesiology TapingMyofascial release is a manual release technique that increases the elasticity and glide between soft tissue layers, reduces this increased muscle activity and pain intensity. Myofascial release is usually characterized by prolonged mechanical forces exerted directly or indirectly on the limited fascial layers with low load. Following the direction of the fascial restraint, the therapist's hands slowly maintain the stretch and allow the fascia to relax on its own. Kinesio Taping is a non-invasive, painless and less time consuming method with fewer side effects. It is an elastic-cotton adhesive tape that is latex-free and can be used on any joint or muscle. It can stretch significantly (130-140% of its original length), which reduces mechanical movement limitations and mimics skin in thickness and elasticity. It is used in the treatment of LBP to reduce muscle tone and stiffness as a rehabilitative taping technique designed to support the body's natural healing process. | Other | Kinesiology Taping Group, Myofascial Release Group |
Primary outcome
Muscle Tone and Stiffness
Time frame: 4 weeks
Muscle tone and stiffness will be evaluated with a myotonometer. The myotonusometer was developed for the objective measurement of mechanical muscle properties. Myotonusometry reflects the viscoelastic properties of the muscle such as tone and stiffness by creating oscillation in the muscle fiber and is an acceptable and reliable method for measuring the mechanical properties of the muscle in young adults with chronic LBP. The device measures muscle tone as the natural oscillation frequency (Hz) calculated as Hz = 1/T; where T is the oscillation time measured in seconds. Muscle stiffness (N/m) is related to the maximum acceleration of oscillation and tissue deformation recorded by the transducer.
Visual Analogue Scale
Time frame: 4 weeks
The Visual Analog Scale is a simple, precise and reproducible tool that is often used to assess pain severity. Due to its easy application, it is one of the most frequently used measurement tools to measure the severity of pain in low back pain. It consists of a horizontal or vertical line ten cm long. The starting point of the line, '0', represents no pain, and the ending point, '10', represents the most severe pain imaginable. Pain intensity increases as you go from 0 to 10. The patient is asked to mark the severity of the pain on the line, the point marked by the patient is recorded in cm.
Joint Range of Motion
Time frame: 4 weeks
Lumbar region flexion, extension, lateral flexion and rotation movements will be measured bilaterally with a digital goniometer. Measurements will be repeated 3 times and the average value will be recorded in degrees.
3 secondary outcomes
Mobility
Time frame: 4 weeks
Progressive İsoinartial Lifting Evaluation
Time frame: 4 weeks
1 Minute Stepping Test
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 21 Sep 2023.
- 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 Myofascial Release Technique and Kinesiology Taping in people with Low Back Pain and Kinesio Taping, run by Istanbul University - Cerrahpasa 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 10 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 21 Sep 2023. 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?
Muscle Tone and Stiffness (time frame: 4 weeks). The study lists 3 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 21 Sep 2023.