Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651671
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Tissue Changes Following Thoracic Myofascial Release
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measuring Muscle Tone in Thoracic Myofascial Release with the MyotonPRO Device
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brief Summary
The goal of this clinical trial is to determine the efficacy of myofascial release in altering the parameters of muscle tone stiffness and viscoelasticity in young adults The main questions it aims to answer are
What is the efficacy of myofascial release in altering muscle tone stiffness and viscoelasticity What is the efficacy of light hands-on sham as a control Are there differences in these parameters between men and women What is the reliability of MyotonPro use in young adults Researchers will randomly allocate and compare the treatment group which receives osteopathic manipulative medicine OMM in the form of 30 seconds of indirect myofascial release followed by 30 seconds of direct myofascial release to the control group which receives 1 minute of light hands-on traps placebo to see if there are differences in muscle tone stiffness and viscoelasticity
The goal of this clinical trial is to determine the efficacy of myofascial release in altering the parameters of muscle tone stiffness and viscoelasticity in young adults The main questions it aims to answer are
What is the efficacy of myofascial release in altering muscle tone stiffness and viscoelasticity What is the efficacy of light hands-on sham as a control Are there differences in these parameters between men and women What is the reliability of MyotonPro use in young adults Researchers will randomly allocate and compare the treatment group which receives osteopathic manipulative medicine OMM in the form of 30 seconds of indirect myofascial release followed by 30 seconds of direct myofascial release to the control group which receives 1 minute of light hands-on traps placebo to see if there are differences in muscle tone stiffness and viscoelasticity
Detailed Description:
Objectives
The primary objective was to determine the efficacy of myofascial release in altering the parameters of muscle tone stiffness and viscoelasticity The secondary objectives are to determine the efficacy of light hands-on sham as a control study the differences in parameters between men and women and measure the reliability of MyotonPro use in young adults
Eligibility Criteria
Participants have to be aged 18 to 35 years old Participants should not have current thoracic spine injuries such as compression fractures or prior thoracic spinal fusions
Exclusion criteria included current or prior thoracic injury or surgery as well as a BMI of less than 300 This exclusion was to maintain study validity considering that gt20mm of subcutaneous fat over the target muscle skews the data per the MyotonPro user manual
Participants will be required to have a target muscle thickness gt3mm which was met as the trapezius was the target muscle for assessment
Participants will report their height and weight during measurement and if they did not meet the criteria their data will be excluded without notification
Study Design
Before treatment participants39 trapezius muscle will be marked and measured at two inches lateral to the level of the T3 spinous process using a skin-safe marker Muscle tone stiffness and viscoelasticity will be measured with the MyotonPRO in an average of five continuous measurements Treatment and myotonometric assessment will be performed either shirtless or in a sports bra in the prone position with participants39 arms by their side Sterilization protocols will be followed between uses and gowns will be available for participant comfort and privacy Informed consent will be signed upon arrival and five minutes will be given for consideration or questions
Participants will be randomly and evenly separated into control n 30 and treatment n 30 groups by an online randomizer The treatment group will receive both direct and indirect myofascial release for thirty seconds each performed by the same practicing osteopathic physician The control group will receive light sham touch for one minute performed by a medical student The sham touch protocol has been shown to be an effective control method in prior studies
Treatment Protocol
Participants lay prone on the table The operator stands at the dominant eye side of the table and palpated bilaterally over the thoracic spine specifically two inches lateral to the level of T3 to assess the trapezius muscle
This location will be marked for precise pre-post treatment testing and palpated for the preferred direction of myofascial tissues
The technique involves placing tissue into its barriers of restriction for direct myofascial release or guiding myofascial into its preference for indirect release
Tissues will be stacked into their direct bind for 30 seconds and then indirect bind for 30 seconds
Post-Treatment Assessment
Immediately following the treatment protocol muscle tone stiffness and elasticity will be re-assessed using the MyotonPro This device objectively quantifies muscle parameters by pressing a superficial probe onto the skin surface producing a 06N force and measuring the rate of probe acceleration and resistance The device auto-corrects for human error and invalidates measurements if excessive movement is detected
For reliability the device will be operated by a single medical student experienced with its use The phrase 34stay as relaxed as possible34 was used before each measurement and each subject was assessed in the same prone position Subjective symptom improvement data was not collected due to lack of power in this study
Statistical Analysis and Measures
A paired t-test will be conducted using the 2024 JASP computer statistical software Version 0190 to compare pre- and post-treatment muscle tone values within each group for the three variables Sample size calculation was done using Gpower V31 Normality assessment and Wilcoxon signed-rank test were used when necessary Effect size was measured and reported with Cohen39s D Results were represented with bar plots to visualize changes in muscle tone stiffness and viscoelasticity
Blinding
Single blinding will be applied participants will be unaware of their treatment group though the study team will know Both groups will receive baseline MyotonPro measurements designed treatment and post-treatment measurement No follow-up or end-of-study visit will be required
The primary objective was to determine the efficacy of myofascial release in altering the parameters of muscle tone stiffness and viscoelasticity The secondary objectives are to determine the efficacy of light hands-on sham as a control study the differences in parameters between men and women and measure the reliability of MyotonPro use in young adults
Eligibility Criteria
Participants have to be aged 18 to 35 years old Participants should not have current thoracic spine injuries such as compression fractures or prior thoracic spinal fusions
Exclusion criteria included current or prior thoracic injury or surgery as well as a BMI of less than 300 This exclusion was to maintain study validity considering that gt20mm of subcutaneous fat over the target muscle skews the data per the MyotonPro user manual
Participants will be required to have a target muscle thickness gt3mm which was met as the trapezius was the target muscle for assessment
Participants will report their height and weight during measurement and if they did not meet the criteria their data will be excluded without notification
Study Design
Before treatment participants39 trapezius muscle will be marked and measured at two inches lateral to the level of the T3 spinous process using a skin-safe marker Muscle tone stiffness and viscoelasticity will be measured with the MyotonPRO in an average of five continuous measurements Treatment and myotonometric assessment will be performed either shirtless or in a sports bra in the prone position with participants39 arms by their side Sterilization protocols will be followed between uses and gowns will be available for participant comfort and privacy Informed consent will be signed upon arrival and five minutes will be given for consideration or questions
Participants will be randomly and evenly separated into control n 30 and treatment n 30 groups by an online randomizer The treatment group will receive both direct and indirect myofascial release for thirty seconds each performed by the same practicing osteopathic physician The control group will receive light sham touch for one minute performed by a medical student The sham touch protocol has been shown to be an effective control method in prior studies
Treatment Protocol
Participants lay prone on the table The operator stands at the dominant eye side of the table and palpated bilaterally over the thoracic spine specifically two inches lateral to the level of T3 to assess the trapezius muscle
This location will be marked for precise pre-post treatment testing and palpated for the preferred direction of myofascial tissues
The technique involves placing tissue into its barriers of restriction for direct myofascial release or guiding myofascial into its preference for indirect release
Tissues will be stacked into their direct bind for 30 seconds and then indirect bind for 30 seconds
Post-Treatment Assessment
Immediately following the treatment protocol muscle tone stiffness and elasticity will be re-assessed using the MyotonPro This device objectively quantifies muscle parameters by pressing a superficial probe onto the skin surface producing a 06N force and measuring the rate of probe acceleration and resistance The device auto-corrects for human error and invalidates measurements if excessive movement is detected
For reliability the device will be operated by a single medical student experienced with its use The phrase 34stay as relaxed as possible34 was used before each measurement and each subject was assessed in the same prone position Subjective symptom improvement data was not collected due to lack of power in this study
Statistical Analysis and Measures
A paired t-test will be conducted using the 2024 JASP computer statistical software Version 0190 to compare pre- and post-treatment muscle tone values within each group for the three variables Sample size calculation was done using Gpower V31 Normality assessment and Wilcoxon signed-rank test were used when necessary Effect size was measured and reported with Cohen39s D Results were represented with bar plots to visualize changes in muscle tone stiffness and viscoelasticity
Blinding
Single blinding will be applied participants will be unaware of their treatment group though the study team will know Both groups will receive baseline MyotonPro measurements designed treatment and post-treatment measurement No follow-up or end-of-study visit will be required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None