Treatment of Muscle Injuries With Physium Therapy.

Not Applicable

• Conditions: Injuries; Muscle, Nontraumatic
• Interventions: Device: Physium treatment

• Registration Number: NCT03762720
• Lead Sponsor: University of Cadiz

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2018-12-02
• Study First Posted: 2018-12-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20
• Study Start: 2019-07-15
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physium treatment	Physium treatment	Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month

Primary Outcome Measures

Name	Time	Method
Time necessary to return to full sport participation.	Baseline	Time necessary to return to full sport participation.

Secondary Outcome Measures

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