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Completed

NCT Number: NCT04352920

Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis

We present the case of a 24-year-old professional soccer player, with no personal history of interest, who came to the X-Ray diagnosis service due to severe pain in the right quadriceps muscle after a 10-month evolution of muscle rupture occurred during sports practice.

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Key information

Conditions

Muscle Injury

Age range

24 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Manuel Rodríguez Huguet

Cadiz, Cádiz, 11008, Spain

About this study

PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms, both in the entire muscle and in muscle fibrosis.

Seven days later, after PHYSIUM System® session with the same parameters of the previous treatment, ultrasound elastography was performed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

.

  • 24-year-old professional soccer player.
  • No personal medical history of interest

Treatment and study plan

experimental group

Other

PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms both in the entire muscle and in muscle fibrosis.

Primary outcomes

  1. The intensity of pain in muscle fibrosis

    Time frame: Baseline

    A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week.

Secondary outcomes

  1. The intensity of pain in muscle fibrosis

    Time frame: Two weeks

    A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of elbow pain, and the worst and lowest level of pain experienced in the preceding week.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Acronym: Physium

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2020
Registry last updated
Feb 2, 2021

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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