Low Back PainNCT05666557
Evaluation of the Erector Spinae Muscle in Different Position and the Change After Receiving Myofascial Release.
A study testing manual erector spinae myofascial realease and self-myofascial release technique in people with Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- manual erector spinae myofascial realease and self-myofascial release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 May 2021to 6 Jun 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 20-65 healthy adult
Who cannot join
- Radicular neurological signs
- spinal deformity e.g.scoliosis, spondylolisthesis
- infection or tumor
- Rheumatologic conditions
- Previous spinal surgery
- History of hip or pelvic disorder that required treatment
- male BMI> 27 and female BMI> 26
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Erector Spinae Muscle Biomechanical Characteristics in Different Position and the Change After Receiving Myofascial Release.
The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.
Read the detailed description
In clinical practice, manual muscle testing (MMT) and Modified Ashworth scale (MAS) grading systems are often used to assess muscle tension and tension. Although these methods are considered feasible, because these methods are mainly classified based on the subjective perception of the evaluator, the reliability and accuracy of the evaluation results are often questioned. Therefore, we should seek a way to objectively evaluate muscle tension with biomechanical properties and quantitative data to solve these deviations. MyotonPRO (Myoton AS, Tallinn, Estonia) is a tester that uses biomechanical principles to collect muscle tension status. This handheld muscle tension tester uses mechanical pressure and reaction force feedback to calculate through biomechanical conversion. The tone, stiffness and elasticity of the muscle are expressed as quantitative data. There have been many use reports showing that the muscle tone meter has the feasibility of quantifying muscle tone.
The erector spinae is one of the most important back muscles of the human body. After contraction, the entire spine can be erected, allowing the upper body to stand upright. When the posture changes, such as: sitting posture, hunchback, bending over, erector spinae will be stretched or continuously contracted due to different postures, resulting in changes in muscle characteristics. Therefore, if the erector spinae is used improperly for long-term poor posture, the erector spinae is easily damaged due to heavy burden, which can easily cause back pain. Myofascial release (myofascial release) is a soft tissue massage method that loosens the fascia with hands. By changing the mechanical properties of the muscles, it can loosen over-tension or tense muscles. It is the most commonly used by physical therapists to loosen muscles. One of the operation techniques. However, there is no literature to quantify the effect of myofascial mobilization. The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.
- Conditions
- Low Back Pain
- Being tested
- manual erector spinae myofascial realease, self-myofascial release technique
- Keywords
- Muscle tension tester, muscle characteristics, erector spinae muscles, different postures, myofascial release
- 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.
manual erector spinae myofascial realeaseOther
The subjects first positioned the third, fourth, and fifth lumbar vertebrae in a relaxed lying position, about 2-3 cm away from the left and right sides (depending on the size of the subjects' muscles). And then in six postures (prone, prone with leg raise, sit straight , slouch sitting, stand straight and slouch standing), MyotonPRO was used to test the above-mentioned 8 points in these position.
Subjects will undergo a pre-mobilization assessment to see if MyotonPRO can detect changes in the erector spinae muscle properties, including changes in muscle tone, stiffness, and elasticity, under different test positions. After physical therapist manual mobilization, MyotonPRO's erector spinae muscle biomechanical data was collected again for data analysis to determine MyotonPRO could objectively quantify changes in erector spinae biomechanical characteristics.
self-myofascial release techniqueOther
The subjects first positioned the third, fourth, and fifth lumbar vertebrae in a relaxed lying position, about 2-3 cm away from the left and right sides (depending on the size of the subjects' muscles). And then in six postures (prone, prone with leg raise, sit straight , slouch sitting, stand straight and slouch standing), MyotonPRO was used to test the above-mentioned 8 points in these position.
Subjects will undergo a pre-mobilization assessment to see if MyotonPRO can detect changes in the erector spinae muscle properties, including changes in muscle tone, stiffness, and elasticity, under different test positions. After self mobilization by roller, MyotonPRO's erector spinae muscle biomechanical data was collected again for data analysis to determine MyotonPRO could objectively quantify changes in erector spinae biomechanical characteristics.
| Study group | Role | What they receive |
|---|---|---|
| manual erector spinae myofascial realease | Experimental | Myofascial release is performed by a therapist. The patient prone and using two pillows, one on the head and the other under the abdomen, flexing the lumbar spine maximally under the abdomen with the erector spinae in extension. The therapist will then perform 3 sets of 15 reps with a 1-minute rest between sets with myofascial loosening using standard massage techniques. Receives: Other: manual erector spinae myofascial realease |
| self-myofascial release technique | Experimental | Use a roller (roller) to release fascia. The subject stand beside the wall and roll back and forth 15 times as a group, rest for one minute in between, and do a total of 3 groups. Receives: Other: self-myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone of manual erector spinae myofascial release
Use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle tone (Hz)
Measured: 10 minutes
muscle stiffness of manual erector spinae myofascial realease
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle stiffness (N/m)
Measured: 10 minutes
muscle elasticity of manual erector spinae myofascial realease
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle elasticity (ln(first wave peak/second wave peak))
Measured: 10 minutes
muscle tone of self-myofascial release technique
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle tone (Hz)
Measured: 10 minutes
muscle stiffness of self-myofascial release technique
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle stiffness (N/m)
Measured: 10 minutes
muscle elasticity of self-myofascial release technique
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle elasticity (ln(first wave peak/second wave peak))
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start11 May 2021
- Primary completion5 Jul 2021
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heng-Yi Lin, Bachelor, Principal investigator, Yueh-Ling Hsieh's bachelor student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666557
- Sponsor's protocol ID
- CMUH110-REC2-071
- Status last verified
- Dec 2022
- First submitted
- 9 Nov 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aarrestad DD, Williams MD, Fehrer SC, Mikhailenok E, Leonard CT. Intra- and interrater reliabilities of the Myotonometer when assessing the spastic condition of children with cerebral palsy. J Child Neurol. 2004 Nov;19(11):894-901. doi: 10.1177/08830738040190110801.
PubMed 15658795Jennings AG, Seedhom BB. The measurement of muscle stiffness in anterior cruciate injuries -- an experiment revisited. Clin Biomech (Bristol). 1998 Mar;13(2):138-140. doi: 10.1016/s0268-0033(97)00085-5.
PubMed 11415781Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.
PubMed 12763442Blackburn JT, Norcross MF, Cannon LN, Zinder SM. Hamstrings stiffness and landing biomechanics linked to anterior cruciate ligament loading. J Athl Train. 2013 Nov-Dec;48(6):764-72. doi: 10.4085/1062-6050-48.4.01. Epub 2013 Jun 14.
PubMed 24303987Brashear A, Zafonte R, Corcoran M, Galvez-Jimenez N, Gracies JM, Gordon MF, McAfee A, Ruffing K, Thompson B, Williams M, Lee CH, Turkel C. Inter- and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil. 2002 Oct;83(10):1349-54. doi: 10.1053/apmr.2002.35474.
PubMed 12370866Brocherie F, Millet GP, Girard O. Neuro-mechanical and metabolic adjustments to the repeated anaerobic sprint test in professional football players. Eur J Appl Physiol. 2015 May;115(5):891-903. doi: 10.1007/s00421-014-3070-z. Epub 2014 Dec 7.
PubMed 25481506
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Erector Spinae Muscle Biomechanical Characteristics in Different Position and the Change After Receiving Myofascial Release.
- ClinicalTrials.gov ID
- NCT05666557
- Acronym / sponsor ID
- CMUH110-REC2-071
- Conditions
- Low Back Pain
- Keywords
- Muscle tension tester, muscle characteristics, erector spinae muscles, different postures, myofascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 28 Dec 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.
The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.
Detailed description
In clinical practice, manual muscle testing (MMT) and Modified Ashworth scale (MAS) grading systems are often used to assess muscle tension and tension. Although these methods are considered feasible, because these methods are mainly classified based on the subjective perception of the evaluator, the reliability and accuracy of the evaluation results are often questioned. Therefore, we should seek a way to objectively evaluate muscle tension with biomechanical properties and quantitative data to solve these deviations. MyotonPRO (Myoton AS, Tallinn, Estonia) is a tester that uses biomechanical principles to collect muscle tension status. This handheld muscle tension tester uses mechanical pressure and reaction force feedback to calculate through biomechanical conversion. The tone, stiffness and elasticity of the muscle are expressed as quantitative data. There have been many use reports showing that the muscle tone meter has the feasibility of quantifying muscle tone.
The erector spinae is one of the most important back muscles of the human body. After contraction, the entire spine can be erected, allowing the upper body to stand upright. When the posture changes, such as: sitting posture, hunchback, bending over, erector spinae will be stretched or continuously contracted due to different postures, resulting in changes in muscle characteristics. Therefore, if the erector spinae is used improperly for long-term poor posture, the erector spinae is easily damaged due to heavy burden, which can easily cause back pain. Myofascial release (myofascial release) is a soft tissue massage method that loosens the fascia with hands. By changing the mechanical properties of the muscles, it can loosen over-tension or tense muscles. It is the most commonly used by physical therapists to loosen muscles. One of the operation techniques. However, there is no literature to quantify the effect of myofascial mobilization. The purpose of this experiment is to evaluate whether MyotonPRO can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual erector spinae myofascial realease | Experimental | Other: manual erector spinae myofascial realeaseMyofascial release is performed by a therapist. The patient prone and using two pillows, one on the head and the other under the abdomen, flexing the lumbar spine maximally under the abdomen with the erector spinae in extension. The therapist will then perform 3 sets of 15 reps with a 1-minute rest between sets with myofascial loosening using standard massage techniques. |
| self-myofascial release technique | Experimental | Other: self-myofascial release techniqueUse a roller (roller) to release fascia. The subject stand beside the wall and roll back and forth 15 times as a group, rest for one minute in between, and do a total of 3 groups. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 20-65 healthy adult
Key exclusion criteria (7 listed)
- Radicular neurological signs
- spinal deformity e.g.scoliosis, spondylolisthesis
- infection or tumor
- Rheumatologic conditions
- Previous spinal surgery
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 |
|---|---|---|
| manual erector spinae myofascial realeaseThe subjects first positioned the third, fourth, and fifth lumbar vertebrae in a relaxed lying position, about 2-3 cm away from the left and right sides (depending on the size of the subjects' muscles). And then in six postures (prone, prone with leg raise, sit straight , slouch sitting, stand straight and slouch standing), MyotonPRO was used to test the above-mentioned 8 points in these position. Subjects will undergo a pre-mobilization assessment to see if MyotonPRO can detect changes in the erector spinae muscle properties, including changes in muscle tone, stiffness, and elasticity, under different test positions. After physical therapist manual mobilization, MyotonPRO's erector spinae muscle biomechanical data was collected again for data analysis to determine MyotonPRO could objectively quantify changes in erector spinae biomechanical characteristics. | Other | manual erector spinae myofascial realease |
| self-myofascial release techniqueThe subjects first positioned the third, fourth, and fifth lumbar vertebrae in a relaxed lying position, about 2-3 cm away from the left and right sides (depending on the size of the subjects' muscles). And then in six postures (prone, prone with leg raise, sit straight , slouch sitting, stand straight and slouch standing), MyotonPRO was used to test the above-mentioned 8 points in these position. Subjects will undergo a pre-mobilization assessment to see if MyotonPRO can detect changes in the erector spinae muscle properties, including changes in muscle tone, stiffness, and elasticity, under different test positions. After self mobilization by roller, MyotonPRO's erector spinae muscle biomechanical data was collected again for data analysis to determine MyotonPRO could objectively quantify changes in erector spinae biomechanical characteristics. | Other | self-myofascial release technique |
Primary outcome
Muscle tone of manual erector spinae myofascial release
Time frame: 10 minutes
Use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle tone (Hz)
muscle stiffness of manual erector spinae myofascial realease
Time frame: 10 minutes
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle stiffness (N/m)
muscle elasticity of manual erector spinae myofascial realease
Time frame: 10 minutes
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle elasticity (ln(first wave peak/second wave peak))
muscle tone of self-myofascial release technique
Time frame: 10 minutes
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle tone (Hz)
muscle stiffness of self-myofascial release technique
Time frame: 10 minutes
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle stiffness (N/m)
muscle elasticity of self-myofascial release technique
Time frame: 10 minutes
use MyotonPRO (Myoton AS, Tallinn, Estonia) to assess the muscle elasticity (ln(first wave peak/second wave peak))
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 28 Dec 2022.
- Background: PubMed 15658795Aarrestad DD, Williams MD, Fehrer SC, Mikhailenok E, Leonard CT. Intra- and interrater reliabilities of the Myotonometer when assessing the spastic condition of children with cerebral palsy. J Child Neurol. 2004 Nov;19(11):894-901. doi: 10.1177/08830738040190110801.
- Background: PubMed 11415781Jennings AG, Seedhom BB. The measurement of muscle stiffness in anterior cruciate injuries -- an experiment revisited. Clin Biomech (Bristol). 1998 Mar;13(2):138-140. doi: 10.1016/s0268-0033(97)00085-5.
- Background: PubMed 12763442Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.
- Background: PubMed 24303987Blackburn JT, Norcross MF, Cannon LN, Zinder SM. Hamstrings stiffness and landing biomechanics linked to anterior cruciate ligament loading. J Athl Train. 2013 Nov-Dec;48(6):764-72. doi: 10.4085/1062-6050-48.4.01. Epub 2013 Jun 14.
- Background: PubMed 12370866Brashear A, Zafonte R, Corcoran M, Galvez-Jimenez N, Gracies JM, Gordon MF, McAfee A, Ruffing K, Thompson B, Williams M, Lee CH, Turkel C. Inter- and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil. 2002 Oct;83(10):1349-54. doi: 10.1053/apmr.2002.35474.
- Background: PubMed 25481506Brocherie F, Millet GP, Girard O. Neuro-mechanical and metabolic adjustments to the repeated anaerobic sprint test in professional football players. Eur J Appl Physiol. 2015 May;115(5):891-903. doi: 10.1007/s00421-014-3070-z. Epub 2014 Dec 7.
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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.
Heng-Yi Lin, Bachelor principal investigator
Yueh-Ling Hsieh's bachelor student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual erector spinae myofascial realease and self-myofascial release technique in people with Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 7 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 28 Dec 2022. 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 Taiwan. 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 of manual erector spinae myofascial release (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05666557, which also lists 6 linked publications.
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 28 Dec 2022.