Myofascial DysfunctionNCT06651671
Tissue Changes Following Thoracic Myofascial Release
A study testing Myofascial release in people with Myofascial Dysfunction and Myofascial Release, run by Rowan University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Dysfunction, Myofascial Release
- What is being tested?
- Myofascial release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 31 Jul 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 year old healthy participants
Who cannot join
- BMI \>30
- No current thoracic spine injuries such as compression fractures or spinal fusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Rowan University, Neuromuscular Institute
Stratford, New Jersey, 08043
About this study
Official title: Measuring Muscle Tone in Thoracic Myofascial Release with the MyotonPRO Device
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.
Read the 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 30.0. This exclusion was to maintain study validity, considering that \>20mm 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 \>3mm, 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, participants\' 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 participants\' 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 0.6N 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 \"stay as relaxed as possible\" 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 0.19.0) to compare pre- and post-treatment muscle tone values within each group for the three variables. Sample size calculation was done using G*power V3.1. Normality assessment and Wilcoxon signed-rank test were used when necessary. Effect size was measured and reported with Cohen\'s 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.
- Conditions
- Myofascial Dysfunction, Myofascial Release
- Being tested
- Myofascial release, Sham (No Treatment)
- Keywords
- Myofascial Release, Osteopathic Manipulative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseProcedure or surgery
THe treatment group was instructed to lay prone on the treatment table such that the skin on their upper back was visible. Participants then received direct and indirect myofascial release for 30 seconds each, performed by the same osteopathic physician.
Sham (No Treatment)Procedure or surgery
The medical student gently placed their hands on the patients back for 60 seconds without manipulating the tissue in any way.
| Study group | Role | What they receive |
|---|---|---|
| Treatment; MFR | Experimental | The treatment group received 30 seconds of direct and indirect myofascial release performed by the same practicing osteopathic physician. Receives: Procedure: Myofascial release |
| Control | Sham comparator | The sham control group received one minute of light sham touch performed by a medical student. Receives: Procedure: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Biomechanical Parameters
Myofascial Tone assessed using a Myotonometer
Measured: Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention
Tissue Biomechanical Parameters
Myofascial Stiffness assessed using a Myotonometer
Measured: Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention
Tissue Biomechanical Parameters
Myofascial Elasticity assessed using a Myotonometer
Measured: Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Mar 2023
- Primary completion30 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial DysfunctionStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander King, DO, Rowan University
- Investigators
- Alexander King, DO, Principal investigator, Rowan-Virtua School of osteopathic medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651671
- Sponsor's protocol ID
- Rowan-PRO-2022-348
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data no longer retained for confidentiality purposes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Muscle Tone in Thoracic Myofascial Release with the MyotonPRO Device
- ClinicalTrials.gov ID
- NCT06651671
- Acronym / sponsor ID
- Rowan-PRO-2022-348
- Conditions
- Myofascial Dysfunction, Myofascial Release
- Keywords
- Myofascial Release, Osteopathic Manipulative Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Oct 2024 (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.
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.
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 30.0. This exclusion was to maintain study validity, considering that \>20mm 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 \>3mm, 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, participants\' 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 participants\' 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 0.6N 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 \"stay as relaxed as possible\" 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 0.19.0) to compare pre- and post-treatment muscle tone values within each group for the three variables. Sample size calculation was done using G*power V3.1. Normality assessment and Wilcoxon signed-rank test were used when necessary. Effect size was measured and reported with Cohen\'s 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment; MFR | Experimental | Procedure: Myofascial releaseThe treatment group received 30 seconds of direct and indirect myofascial release performed by the same practicing osteopathic physician. |
| Control | Sham comparator | Procedure: Sham (No Treatment)The sham control group received one minute of light sham touch performed by a medical student. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-35 year old healthy participants
Key exclusion criteria (2 listed)
- BMI \>30
- No current thoracic spine injuries such as compression fractures or spinal fusions
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 releaseTHe treatment group was instructed to lay prone on the treatment table such that the skin on their upper back was visible. Participants then received direct and indirect myofascial release for 30 seconds each, performed by the same osteopathic physician. | Procedure or surgery | Treatment; MFR |
| Sham (No Treatment)The medical student gently placed their hands on the patients back for 60 seconds without manipulating the tissue in any way. | Procedure or surgery | Control |
Primary outcome
Tissue Biomechanical Parameters
Time frame: Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention
Myofascial Tone assessed using a Myotonometer
Tissue Biomechanical Parameters
Time frame: Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention
Myofascial Stiffness assessed using a Myotonometer
Tissue Biomechanical Parameters
Time frame: Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention
Myofascial Elasticity assessed using a Myotonometer
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 22 Oct 2024.
- Individual participant dataSharing planned: No. Data no longer retained for confidentiality purposes
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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.
Alexander King, DO principal investigator
Rowan-Virtua School of osteopathic medicine
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 in people with Myofascial Dysfunction and Myofascial Release, run by Rowan University at 1 site in United States.
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 2 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 22 Oct 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Tissue Biomechanical Parameters (time frame: Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention). 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 22 Oct 2024.