Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis

Muscle Injury Clinical Trial

— Physium  

Official title:

Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352920
• Other study ID #: 27/19
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 3, 2019

Study information

• Verified date: January 2021
• Source: University of Cadiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 3, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 24 Years and older

Eligibility

Inclusion criteria.

• 24-year-old professional soccer player.

• No personal medical history of interest

Related Conditions & MeSH terms

• Fibrosis
• Muscle Injury

Intervention

Other:
• Experimental group
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.

Locations

Country	Name	City	State
Spain	Manuel Rodríguez Huguet	Cadiz	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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-2 — View 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.20 — View Citation

Hallén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Two weeks