Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis

NCT04352920 | Completed DMC

• 1 other identifier: 27/19
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Injury

Keywords

negative pressure; cupping; physical therapy modalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The intensity of pain in muscle fibrosis

  Two weeks

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Other: Experimental group

Interventions

Experimental group OTHER

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.

Experimental group

Eligibility Criteria

• Age: 24 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old professional soccer player.
• No personal medical history of interest

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Manuel Rodríguez Huguet

Cadiz, Cádiz, 11008, Spain

Location

Related 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.

  PMID: 23070932 RESULT

• 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.

  PMID: 23645834 RESULT

• 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.

  PMID: 24784885 RESULT

• 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.

  PMID: 21119022 RESULT

Study Officials

• Manuel Rodriguez Huguet, Physiotherapy

  University of Cádiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assesor
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Medical Doctor diagnosed muscle fibrosis

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: August 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: October 3, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

ES (1)