Back to resultsVacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis (Physium)
Primary Purpose
Muscle Injury
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental group
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Injury focused on measuring negative pressure, cupping, physical therapy modalities
Eligibility Criteria
Inclusion criteria.
- 24-year-old professional soccer player.
- No personal medical history of interest
Sites / Locations
- Manuel Rodríguez Huguet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
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.
Outcomes
Primary Outcome Measures
The intensity of pain in muscle fibrosis
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 Outcome Measures
The intensity of pain in muscle fibrosis
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04352920
Brief Title
Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis
Acronym
Physium
Official Title
Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
October 3, 2019 (Actual)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury
Keywords
negative pressure, cupping, physical therapy modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Medical Doctor diagnosed muscle fibrosis
Masking
None (Open Label)
Masking Description
Outcomes assesor
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental group
Intervention Description
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 Outcome Measure Information:
Title
The intensity of pain in muscle fibrosis
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 elbow pain, and the worst and lowest level of pain experienced in the preceding week.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The intensity of pain in muscle fibrosis
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 elbow pain, and the worst and lowest level of pain experienced in the preceding week.
Time Frame
Two weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria.
24-year-old professional soccer player.
No personal medical history of interest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Rodriguez Huguet, Physiotherapy
Organizational Affiliation
University of Cádiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manuel Rodríguez Huguet
City
Cadiz
State/Province
Cádiz
ZIP/Postal Code
11008
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23070932
Citation
Bhatia K, Tong CS, Cho CC, Yuen EH, Lee J, Ahuja AT. Reliability of shear wave ultrasound elastography for neck lesions identified in routine clinical practice. Ultraschall Med. 2012 Oct;33(5):463-8. doi: 10.1055/s-0032-1325330. Epub 2012 Oct 15.
Results Reference
result
PubMed Identifier
23645834
Citation
Ekstrand J, Askling C, Magnusson H, Mithoefer K. Return to play after thigh muscle injury in elite football players: implementation and validation of the Munich muscle injury classification. Br J Sports Med. 2013 Aug;47(12):769-74. doi: 10.1136/bjsports-2012-092092. Epub 2013 May 5.
Results Reference
result
PubMed Identifier
24784885
Citation
Hallen A, Ekstrand J. Return to play following muscle injuries in professional footballers. J Sports Sci. 2014;32(13):1229-36. doi: 10.1080/02640414.2014.905695. Epub 2014 May 1.
Results Reference
result
PubMed Identifier
21119022
Citation
Fousekis K, Tsepis E, Poulmedis P, Athanasopoulos S, Vagenas G. Intrinsic risk factors of non-contact quadriceps and hamstring strains in soccer: a prospective study of 100 professional players. Br J Sports Med. 2011 Jul;45(9):709-14. doi: 10.1136/bjsm.2010.077560. Epub 2010 Nov 30.
Results Reference
result
Learn more about this trial
Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis
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