Muscle InjuryPhase 2NCT03676205
Platelet-Rich Plasma in Acute Muscle Injuries
A Phase 2 study testing PRP and Traumeel in people with Muscle Injury, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries. Efficacy and safety are evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Injury
- What is being tested?
- PRP and Traumeel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 3 Oct 2016to 8 Jan 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
- Informed consent signed
Who cannot join
- Hamstring injury (last 6 months).
- Previous infiltration in hamstring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.
OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries.
Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.
Read the detailed description
STUDY DESIGN: Randomized Clinical Trial.
METHODS:
41 football players are included in the study. It is used randomly PRP injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours).
One week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. It is compared the elapsed time in days in each of the groups: RETURN TO PLAY.
Furthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.
- Conditions
- Muscle Injury
- Being tested
- PRP, Traumeel
- Keywords
- Platelet-Rich Plasma, hamstrings, cuadriceps, football players
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Platelet-Rich Plasma
TraumeelOther
Homeophatic Treatment
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma | Experimental | 24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 6-7 ml of PRP .
After 4-5 days from the injury the patient starts physiotherapy adapted by stages, according to the muscular group affected.
After 7 days from the first infiltration, the patient will recived the second infiltration of 6-7 ml of PRP. Receives: Biological: PRP |
| Traumel ® | Other | 24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 4 ml of a homeopathic product (Traumeel ®) After 4-5 days from the date of injury, the patient starts physiotherapy adapted by stages, according to the muscular group affected.
After 7 days from the first infiltration, the patient will receive the second infiltration of 4 ml of a homeopathic product. Receives: Other: Traumeel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to play (recovery period)
Days elapsed since muscular injury apperars until the return to play
Measured: average of 3-6 weeks. Until play again a football match (training or competition)
Pain intensity
Pain after the muscle injury, and after the injections, with:
-Funtional outcomes: pain (0 no pain; 10 unbearable pain) at rest, walking and going up and down the stairs.
The Brief Pain Inventory - Short Form. Pain intensity (0, no pain - 10 unbearable) and interferences with the daily activities (0, does not interfere; 10, completely interferes).
Measured: 3 months since the injury
Secondary outcomes (2)
Incidence of Recurrences
Recurrence: other injury in the same muscle group during the 6 months after the first injury Complication: other injurie or disease in other location of the body (no in the same muscular group).
Measured: Less than 6 months since the first injury
Number of adverse effects
Any reaction with the product injected
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start3 Oct 2016
- Primary completion8 Apr 2019
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle InjuryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier González Iglesias, University of the Basque Country (UPV/EHU)
- Investigators
- Javier Gonzalez Iglesias, Dr, Principal investigator, Basque Health System - Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676205
- Sponsor's protocol ID
- PRP-MUSCULO-2014-2019
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Iglesias J. [Therapeutic potential of platelet rich plasma. Reflections on its research and development]. Rev Esp Cir Ortop Traumatol. 2013 Jul-Aug;57(4):237-9. doi: 10.1016/j.recot.2013.04.001. Epub 2013 May 28. No abstract available. Spanish.
PubMed 23885648
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.
- ClinicalTrials.gov ID
- NCT03676205
- Acronym / sponsor ID
- PRP-MUSCULO-2014-2019
- Conditions
- Muscle Injury
- Keywords
- Platelet-Rich Plasma, hamstrings, cuadriceps, football players
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 18 Sep 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.
OBJECTIVE: To evaluate the effect of Platelet Rich Plasma (PRP) injection in muscle injuries. The investigators check football players in the acute phase of hamstrings or quadriceps injuries.
Efficacy and safety are evaluated. There are two intramuscular infiltration of PRP (Ortho pras ® system) or a homeopathic product (Traumeel ®) in each of the football players. The number of days between the date of injury and the return to play, the pain, the recurrence and the adverse reactions are registered.
Detailed description
STUDY DESIGN: Randomized Clinical Trial.
METHODS:
41 football players are included in the study. It is used randomly PRP injection or a homeopathic product in muscle injuries (hamstring), in the early stage (first 48-72 hours).
One week later, the investigators do a second infiltration with the same product, always ultrasound guided. 3-4 weeks after the injury, different variables are evaluated: the injurie with ultrasounds , self-perception test, muscle strength, flexibility, jump and run. It is compared the elapsed time in days in each of the groups: RETURN TO PLAY.
Furthermore, the PAIN, RECURRENCE RATE and ADVERSE REACTIONS are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma | Experimental | Biological: PRP24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 6-7 ml of PRP . After 4-5 days from the injury the patient starts physiotherapy adapted by stages, according to the muscular group affected. After 7 days from the first infiltration, the patient will recived the second infiltration of 6-7 ml of PRP. |
| Traumel ® | Other | Other: Traumeel24-72 hours after having a muscular lesion, the doctor injects an intramuscular ecoguided infiltration of 4 ml of a homeopathic product (Traumeel ®) After 4-5 days from the date of injury, the patient starts physiotherapy adapted by stages, according to the muscular group affected. After 7 days from the first infiltration, the patient will receive the second infiltration of 4 ml of a homeopathic product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old.
- Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
- Informed consent signed
Key exclusion criteria (2 listed)
- Hamstring injury (last 6 months).
- Previous infiltration in hamstring.
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 |
|---|---|---|
| PRPPlatelet-Rich Plasma | Biological | Platelet-Rich Plasma |
| TraumeelHomeophatic Treatment | Other | Traumel ® |
Primary outcome
Return to play (recovery period)
Time frame: average of 3-6 weeks. Until play again a football match (training or competition)
Days elapsed since muscular injury apperars until the return to play
Pain intensity
Time frame: 3 months since the injury
Pain after the muscle injury, and after the injections, with: -Funtional outcomes: pain (0 no pain; 10 unbearable pain) at rest, walking and going up and down the stairs. The Brief Pain Inventory - Short Form. Pain intensity (0, no pain - 10 unbearable) and interferences with the daily activities (0, does not interfere; 10, completely interferes).
2 secondary outcomes
Incidence of Recurrences
Time frame: Less than 6 months since the first injury
Number of adverse effects
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Results publication: PubMed 23885648Gonzalez-Iglesias J. [Therapeutic potential of platelet rich plasma. Reflections on its research and development]. Rev Esp Cir Ortop Traumatol. 2013 Jul-Aug;57(4):237-9. doi: 10.1016/j.recot.2013.04.001. Epub 2013 May 28. No abstract available. Spanish.
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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.
Javier Gonzalez Iglesias, Dr principal investigator
Basque Health System - Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP and Traumeel in people with Muscle Injury, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to play (recovery period) (time frame: average of 3-6 weeks. Until play again a football match (training or competition)). The study lists 2 primary outcomes in all. 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 NCT03676205, which also lists 1 linked publication.
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 22 Jan 2020.