Injuries; Muscle, NontraumaticPhysiumNCT03762720
Treatment of Muscle Injuries With Physium Therapy.
A study testing Physium treatment in people with Injuries; Muscle, Nontraumatic, run by University of Cadiz.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injuries; Muscle, Nontraumatic
- What is being tested?
- Physium treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown.
Who cannot join
- Patients who are pregnant, have pacemakers and surgically operated in the area to be treated.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Injuries; Muscle, Nontraumatic
- Being tested
- Physium treatment
- Keywords
- Manual Therapy, Massage, physium, pain, range of motion, quality of life, muscle injuries
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physium treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Physium treatment | Experimental | Patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month Receives: Device: Physium treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time necessary to return to full sport participation.
Time necessary to return to full sport participation.
Measured: Baseline
Secondary outcomes (6)
Time necessary to return to full sport participation.
Time necessary to return to full sport participation.
Measured: Four weeks.
Range of motion.
Measured by goniometer.
Measured: Baseline and four weeks
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.
Measured: Baseline and four weeks
Pressure pain thresholds in cervical trigger points
Pressure pain thresholds (PPTs) will be measured with a pressure algometer
Measured: Baseline and four weeks
Questionnaire SF 12
The multidimensional health related quality of life
Measured: Baseline and four weeks
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.
Measured: Baseline and four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start15 Jul 2019 (estimated)
- Primary completion15 Aug 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Injuries; Muscle, NontraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Rodriguez Huguet, University of Cadiz
- Investigators
- Manuel Rodriguez Huguet, Physiotherapy, Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762720
- Sponsor's protocol ID
- Muscle injuries
- Acronym
- Physium
- Status last verified
- Jun 2019
- First submitted
- 2 Dec 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23536466Guermazi 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.
PubMed 29155622Lee 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.
PubMed 22496067Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. No abstract available.
PubMed 23045734Kinser 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.
PubMed 19130648Bonilla D, Hortalá G, Temporal D, CarréLlopis C. PHYSIUM in thetreatment of pain in patientswithchroniclow back pain. FisioGlía. 2015;2(3):50-55.
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.
PubMed 14987620Ko 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.
PubMed 27073401Chesterton 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.
PubMed 12583868Vilagut 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.
PubMed 18570798Price 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.
PubMed 6226917Ayala 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.
PubMed 24405028Ohno 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.
PubMed 27699732
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Muscle Injuries With Physium Therapy.
- ClinicalTrials.gov ID
- NCT03762720
- Acronym / sponsor ID
- Physium / Muscle injuries
- Conditions
- Injuries; Muscle, Nontraumatic
- Keywords
- Manual Therapy, Massage, physium, pain, range of motion, quality of life, muscle injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 15 Aug 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
| Arm | Type | Receives |
|---|---|---|
| Physium treatment | Experimental | Device: Physium treatmentPatients will receive five sessions of physium therapy at 80 millibars in 30 minutes for a month |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown.
Key exclusion criteria (1 listed)
- Patients who are pregnant, have pacemakers and surgically operated in the area to be treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physium treatmentpatients 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. | Device | Physium treatment |
Primary outcome
Time necessary to return to full sport participation.
Time frame: Baseline
Time necessary to return to full sport participation.
6 secondary outcomes
Time necessary to return to full sport participation.
Time frame: Four weeks.
Range of motion.
Time frame: Baseline and four weeks
The intensity of pain
Time frame: Baseline and four weeks
Pressure pain thresholds in cervical trigger points
Time frame: Baseline and four weeks
Questionnaire SF 12
Time frame: Baseline and four weeks
the extent of sports-related muscle injuries
Time frame: Baseline and four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Background: PubMed 23536466Askling 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.
- Background: PubMed 29155622Guermazi 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.
- Background: PubMed 22496067Lee 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.
- Background: PubMed 23045734Sporea I, Lie I. Shear wave elastography. Ultraschall Med. 2012 Aug;33(4):393-4. No abstract available.
- Background: PubMed 19130648Kinser 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.
- BackgroundBonilla D, Hortalá G, Temporal D, CarréLlopis C. PHYSIUM in thetreatment of pain in patientswithchroniclow back pain. FisioGlía. 2015;2(3):50-55.
- Background: PubMed 14987620Maquet 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.
- Background: PubMed 27073401Ko 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.
- Background: PubMed 12583868Chesterton 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.
- Background: PubMed 18570798Vilagut 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.
- Background: PubMed 6226917Price 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.
- Background: PubMed 24405028Ayala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Rodriguez Huguet, Physiotherapy principal investigator
University of Cadiz
Questions about this trial
What is this clinical trial studying?
A study testing Physium treatment in people with Injuries; Muscle, Nontraumatic, run by University of Cadiz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Rodriguez Huguet, Physiotherapy (+34606176814, manuel.rodriguez@uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time necessary to return to full sport participation. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762720, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.