Treatment of Muscle Injuries With Physium Therapy.

NCT ID: NCT03762720

Last Updated: 2019-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2019-08-15

Brief Summary

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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

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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.

Conditions

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Injuries; Muscle, Nontraumatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Blind researcher

Study Groups

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Physium treatment

Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month

Group Type EXPERIMENTAL

Physium treatment

Intervention Type DEVICE

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.

Interventions

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Physium treatment

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Manuel Rodriguez Huguet

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Rodriguez Huguet, Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

University of Cadiz

Central Contacts

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Manuel Rodriguez Huguet, Physiotherapy

Role: CONTACT

+34606176814

References

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Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.

Reference Type BACKGROUND
PMID: 23536466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29155622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22496067 (View on PubMed)

Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. No abstract available.

Reference Type BACKGROUND
PMID: 23045734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19130648 (View on PubMed)

Bonilla D, Hortalá G, Temporal D, CarréLlopis C. PHYSIUM in thetreatment of pain in patientswithchroniclow back pain. FisioGlía. 2015;2(3):50-55.

Reference Type BACKGROUND

Maquet D, Croisier JL, Demoulin C, Crielaard JM. Pressure pain thresholds of tender point sites in patients with fibromyalgia and in healthy controls. Eur J Pain. 2004 Apr;8(2):111-7. doi: 10.1016/S1090-3801(03)00082-X.

Reference Type BACKGROUND
PMID: 14987620 (View on PubMed)

Ko SJ, Kim H, Kim SK, Park K, Lee J, Lee BJ, Oh J, Lee K, Park JW. Reliability and Validity of Modified Algometer in Abdominal Examination. Evid Based Complement Alternat Med. 2016;2016:3052954. doi: 10.1155/2016/3052954. Epub 2016 Mar 17.

Reference Type BACKGROUND
PMID: 27073401 (View on PubMed)

Chesterton LS, Barlas P, Foster NE, Baxter DG, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-266. doi: 10.1016/S0304-3959(02)00330-5.

Reference Type BACKGROUND
PMID: 12583868 (View on PubMed)

Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.

Reference Type BACKGROUND
PMID: 18570798 (View on PubMed)

Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

Reference Type BACKGROUND
PMID: 6226917 (View on PubMed)

Ayala F, De Ste Croix M, Sainz de Baranda P, Santonja F. Acute effects of static and dynamic stretching on hamstrings' response times. J Sports Sci. 2014;32(9):817-25. doi: 10.1080/02640414.2013.861606. Epub 2014 Jan 10.

Reference Type BACKGROUND
PMID: 24405028 (View on PubMed)

Ohno Y, Fujimoto T, Shibata Y. A New Era in Diagnostic Ultrasound, Superb Microvascular Imaging: Preliminary Results in Pediatric Hepato-Gastrointestinal Disorders. Eur J Pediatr Surg. 2017 Feb;27(1):20-25. doi: 10.1055/s-0036-1593381. Epub 2016 Oct 3.

Reference Type BACKGROUND
PMID: 27699732 (View on PubMed)

Other Identifiers

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Muscle injuries

Identifier Type: -

Identifier Source: org_study_id

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