NCT06651671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

September 27, 2024

Last Update Submit

October 18, 2024

Conditions

Keywords

Myofascial ReleaseOsteopathic Manipulative Medicine

Outcome Measures

Primary Outcomes (3)

  • Tissue Biomechanical Parameters

    Myofascial Tone assessed using a Myotonometer

    Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention

  • Tissue Biomechanical Parameters

    Myofascial Stiffness assessed using a Myotonometer

    Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention

  • Tissue Biomechanical Parameters

    Myofascial Elasticity assessed using a Myotonometer

    Baseline will be assessed Immediately pre-treatment, with follow up assessed immediately after the intervention

Study Arms (2)

Treatment; MFR

EXPERIMENTAL

The treatment group received 30 seconds of direct and indirect myofascial release performed by the same practicing osteopathic physician.

Procedure: Myofascial release

Control

SHAM COMPARATOR

The sham control group received one minute of light sham touch performed by a medical student.

Procedure: Sham (No Treatment)

Interventions

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.

Treatment; MFR

The medical student gently placed their hands on the patients back for 60 seconds without manipulating the tissue in any way.

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old healthy participants

You may not qualify if:

  • BMI \>30
  • No current thoracic spine injuries such as compression fractures or spinal fusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan University, Neuromuscular Institute

Stratford, New Jersey, 08043, United States

Location

MeSH Terms

Interventions

Myofascial Release Therapysalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Alexander King, DO

    Rowan-Virtua School of osteopathic medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Assistant Professor

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 22, 2024

Study Start

March 30, 2023

Primary Completion

July 30, 2023

Study Completion

July 31, 2023

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Data no longer retained for confidentiality purposes

Locations