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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
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 2, 2018
    Last Updated
    June 18, 2019
    Sponsor
    University of Cadiz
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    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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    Results Reference
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    PubMed Identifier
    29155622
    Citation
    Guermazi A, Roemer FW, Robinson P, Tol JL, Regatte RR, Crema MD. Imaging of Muscle Injuries in Sports Medicine: Sports Imaging Series. Radiology. 2017 Dec;285(3):1063. doi: 10.1148/radiol.2017174038. No abstract available.
    Results Reference
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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.
    Results Reference
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    PubMed Identifier
    23045734
    Citation
    Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. No abstract available.
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    PubMed Identifier
    19130648
    Citation
    Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. doi: 10.1519/jsc.0b013e31818f051c.
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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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