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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03762720
Other study ID # Muscle injuries
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date August 15, 2019

Study information

Verified date June 2019
Source University of Cadiz
Contact Manuel Rodriguez Huguet, Physiotherapy
Phone +34606176814
Email manuel.rodriguez@uca.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date August 15, 2019
Est. primary completion date August 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Cadiz

References & Publications (13)

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. — View Citation

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. — View Citation

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

Chesterton LS, Barlas P, Foster NE, Baxter GD, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-66. — View 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. — View Citation

Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. — View Citation

Vilagut G, Valderas JM, Ferrer M, Garin O, López-García 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. Spanish. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Time necessary to return to full sport participation. Time necessary to return to full sport participation. Baseline
Secondary Time necessary to return to full sport participation. Time necessary to return to full sport participation. Four weeks.
Secondary Range of motion. Measured by goniometer. Baseline and four weeks
Secondary 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. Baseline and four weeks
Secondary Pressure pain thresholds in cervical trigger points Pressure pain thresholds (PPTs) will be measured with a pressure algometer Baseline and four weeks
Secondary Questionnaire SF 12 The multidimensional health related quality of life Baseline and four weeks
Secondary 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. Baseline and four weeks