Treatment of Muscle Injuries With Physium Therapy. (Physium)

June 18, 2019 updated by: Manuel Rodriguez Huguet, University of Cadiz

Muscle injuries are currently particularly frequent among people who participate in sports.

The diagnosis is easily made with an ultrasound study and Shear Wave Elastography.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients of the experimental group, after diagnosis by ultrasound and Shear Wave Elastography , will receive five sessions of physium therapy at 80 millibars during one month.

The measurements of the variables visual analog scale, joint mobility through the double inclinometer device, elasticity and tissue vascularization through the ultrasound, quality of life through SF-12 questionnaire and pressure algometry will be made before, after, month and three months after the end of treatment.

Study Type

Interventional

Enrollment (Anticipated)

20

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.

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown.

Exclusion Criteria:

  • Patients who are pregnant, have pacemakers and surgically operated in the area to be treated.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physium treatment
Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month
Device: Physium treatment
patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for one month in muscle injury and diagnosed by ultrasound and Shear Wave Elastography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time necessary to return to full sport participation.
Time Frame: Baseline
Time necessary to return to full sport participation.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time necessary to return to full sport participation.
Time Frame: Four weeks.
Time necessary to return to full sport participation.
Four weeks.
Range of motion.
Time Frame: Baseline and four weeks
Measured by goniometer.
Baseline and four weeks
The intensity of pain
Time Frame: Baseline and four 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 pain, and the worst and lowest level of pain experienced in the preceding week in the area.
Baseline and four weeks
Pressure pain thresholds in cervical trigger points
Time Frame: Baseline and four weeks
Pressure pain thresholds (PPTs) will be measured with a pressure algometer
Baseline and four weeks
Questionnaire SF 12
Time Frame: Baseline and four weeks
The multidimensional health related quality of life
Baseline and four weeks
the extent of sports-related muscle injuries
Time Frame: Baseline and four weeks
Imaging is crucial to confirm and assess the extent of sports-related muscle injuries and may help to guide management.
Baseline and four weeks

Collaborators and Investigators

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

Sponsor

University of Cadiz

Investigators

  • Principal Investigator: manuel Rodríguez Huguet, Physiotherapy, University of Cadiz

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 (Anticipated)

July 15, 2019

Primary Completion (Anticipated)

August 15, 2019

Study Completion (Anticipated)

August 15, 2019

Study Registration Dates

First Submitted

December 2, 2018

First Submitted That Met QC Criteria

December 2, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Muscle injuries

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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