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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT06651671
Study groupRoleWhat they receive
Treatment; MFRExperimentalThe treatment group received 30 seconds of direct and indirect myofascial release performed by the same practicing osteopathic physician.
Receives: Procedure: Myofascial release
ControlSham comparatorThe 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.

  1. 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

  2. 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

  3. 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.

  1. First posted22 Oct 2024
  2. Study start30 Mar 2023
  3. Primary completion30 Jul 2023
  4. Study completion31 Jul 2023

Resources

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)
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

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.

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