Treatment of Muscle Injuries With Physium Therapy. (Physium)
Primary Purpose
Injuries; Muscle, Nontraumatic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physium treatment
Sponsored by
About this trial
This is an interventional treatment trial for Injuries; Muscle, Nontraumatic focused on measuring Manual Therapy, Massage, physium, pain, range of motion, quality of life, muscle injuries
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physium treatment
Arm Description
Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month
Outcomes
Primary Outcome Measures
Time necessary to return to full sport participation.
Time necessary to return to full sport participation.
Secondary Outcome Measures
Time necessary to return to full sport participation.
Time necessary to return to full sport participation.
Range of motion.
Measured by goniometer.
The intensity of pain
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
Pressure pain thresholds (PPTs) will be measured with a pressure algometer
Questionnaire SF 12
The multidimensional health related quality of life
the extent of sports-related muscle injuries
Imaging is crucial to confirm and assess the extent of sports-related muscle injuries and may help to guide management.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03762720
Brief Title
Treatment of Muscle Injuries With Physium Therapy.
Acronym
Physium
Official Title
Treatment of Muscle Injuries With Physium Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Anticipated)
Primary Completion Date
August 15, 2019 (Anticipated)
Study Completion Date
August 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries; Muscle, Nontraumatic
Keywords
Manual Therapy, Massage, physium, pain, range of motion, quality of life, muscle injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Masking
None (Open Label)
Masking Description
Blind researcher
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physium treatment
Arm Type
Experimental
Arm Description
Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month
Intervention Type
Device
Intervention Name(s)
Physium treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time necessary to return to full sport participation.
Description
Time necessary to return to full sport participation.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Time necessary to return to full sport participation.
Description
Time necessary to return to full sport participation.
Time Frame
Four weeks.
Title
Range of motion.
Description
Measured by goniometer.
Time Frame
Baseline and four weeks
Title
The intensity of pain
Description
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.
Time Frame
Baseline and four weeks
Title
Pressure pain thresholds in cervical trigger points
Description
Pressure pain thresholds (PPTs) will be measured with a pressure algometer
Time Frame
Baseline and four weeks
Title
Questionnaire SF 12
Description
The multidimensional health related quality of life
Time Frame
Baseline and four weeks
Title
the extent of sports-related muscle injuries
Description
Imaging is crucial to confirm and assess the extent of sports-related muscle injuries and may help to guide management.
Time Frame
Baseline and four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Rodriguez Huguet, Physiotherapy
Phone
+34606176814
Email
manuel.rodriguez@uca.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Rodriguez Huguet, Physiotherapy
Organizational Affiliation
University of Cadiz
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23536466
Citation
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Citation
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PubMed Identifier
22496067
Citation
Lee JC, Mitchell AW, Healy JC. Imaging of muscle injury in the elite athlete. Br J Radiol. 2012 Aug;85(1016):1173-85. doi: 10.1259/bjr/84622172. Epub 2012 Apr 11.
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PubMed Identifier
23045734
Citation
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PubMed Identifier
19130648
Citation
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Citation
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Citation
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Treatment of Muscle Injuries With Physium Therapy.
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