The Impact of Myofascial Therapy on Connective Tissue

April 25, 2025 updated by: Adrian Rogala, Józef Piłsudski University of Physical Education

The study involved patients who suffered from myofascial pain caused occupational or sports overloads or muscle strains caused by sports or improper preparation for physical activity. The patients had not been previously treated for this reason. The only form of therapy was self-administered over-the-counter painkillers and ointments. Due to lack of relief, patients received one of two types of treatments, myofascial therapy or deep tissue massage. Each group was divided into three subgroups, depending on the location of the symptoms: arm, forearm, calf. The patients received three treatments on alternate days. Ultrasound imaging examination was performed by a physiotherapist, qualified to assess soft tissues using an USG. Two measurements were taken, before and seven days after therapy. To standardise the assessment, ultrasound imaging protocol was used.

The thickness of the fascia was measured by ImageJ software. The aim of the study was an ultrasound imaging assessment of connective tissue of patients undergone myofascial therapy.

Study Overview

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Warsaw, Poland, 00-968
        • Józef Piłsudski University of Physical Education in Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • undergone myofascial therapy
  • undergone deep tissue massage
  • patients with pain of musculoskeletal origin
  • without contraindications to myofascial therapy
  • without neurological diseases
  • voluntary consent to participate in the study

Exclusion Criteria:

  • resignation from the study
  • lack of patient consent
  • cancers
  • disturbed continuity of skin tissue at the examination site
  • previous surgical procedures at the study site
  • large vascular changes
  • inflammatory changes in the examined areas of the body
  • sensory disturbances in the examined body areas
  • resignation from therapy
  • changing the type of therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myofascial therapy
The myofascial therapy in the form of Fascial Distortion Model (FDM) method is based on the idea that issues within the musculoskeletal system stem from deformations or distortions in the fascia. Once the type of deformation is identified, a specific technique is employed by the physiotherapist using their hands and pressure. FDM identifies six types of fascial distortions that can cause pain and other musculoskeletal issues. These distortions include triggerbands, continuum distortions, cylinder distortions, herniated triggerpoints, tectonic fixations, and folding distortions.
Experimental: Deep Tissue Massage

A deep tissue massage is a therapeutic technique that focuses on realigning deeper layers of muscles and connective tissue. It is particularly beneficial for individuals dealing with chronic pain, muscle tension, or injury recovery.

The physiotherapist uses more intense pressure compared to other massage types, like Swedish massage. The goal is to reach deeper muscle layers to relieve tension and pain. The therapist employs various techniques, including long, slow strokes, deep finger pressure, and friction, also use elbows, knuckles, or forearms to apply pressure to specific areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The thickness of the deep and superficial fascia.
Time Frame: From enrollment to the 7 days after last therapy.
To assessed the thickness of the deep and superficial fascia, ultrasound imaging examination (USG) was performed by qualified physiotherapist. Two measurements were taken, before and seven days after therapy. Philips Affiniti 70G ultrasound device with linear probe (2-15 MHz) was used. To standardize the assessment, ultrasound imaging protocol described by Pirri et al. 2022 was used. To obtain more accurate results, the ultrasound image of the examined tissue was placed in the ImageJ ver. 1.54 software to assess the fascia thickness in millimetres.
From enrollment to the 7 days after last therapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: From enrollment to the 7 days after last therapy.
To assess the pain level, Visual Analogue Scale (VAS) was used. It is a simple but valuable instrument that measure a level of pain, by range across a continuum of values and cannot easily be directly measured. The scale is a horizontal line, 100 mm in length, anchored by word descriptors at each end, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marked on the line the point that the patient believed represents his or her perception of his or her current state.
From enrollment to the 7 days after last therapy.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Once - upon enrollment
A digital scale was used to assess the patients' body weight. The unit of measurement used in the study was kilograms.
Once - upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • JozefPilsudski_U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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