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Completed

NCT Number: NCT06950541

The Impact of Myofascial Therapy on Connective Tissue

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.

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Key information

Conditions

Painful Fascia Fascial Manipulation Myofascial Myofascial Dysfunction Myofascial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Józef Piłsudski University of Physical Education in Warsaw

Warsaw, 00-968, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofascial therapy

Procedure

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.

Deep tissue massage

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Józef Piłsudski University of Physical Education

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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