Platelet-Rich Plasma in Acute Muscle Injuries

Muscle Injury Clinical Trial

Official title:

Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676205
• Other study ID #: PRP-MUSCULO-2014-2019
• Status: Completed
• Phase: Phase 2
• Start date: October 3, 2016
• Est. completion date: January 8, 2020

Study information

• Verified date: January 2020
• Source: Basque Country University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 8, 2020
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old.

• Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles

• Informed consent signed

Exclusion Criteria:

• Hamstring injury (last 6 months).

• Previous infiltration in hamstring.

Related Conditions & MeSH terms

• Muscle Injury
• Wounds and Injuries

Intervention

Biological:
• PRP
Platelet-Rich Plasma

Other:
• Traumeel
Homeophatic Treatment

Locations

Country	Name	City	State
Spain	Javier Gonzalez Iglesias	Bilbao	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
Basque Country University

Country where clinical trial is conducted

Spain, 

References & Publications (1)

González-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. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to play (recovery period)	Days elapsed since muscular injury apperars until the return to play	average of 3-6 weeks. Until play again a football match (training or competition)
Primary	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).	3 months since the injury
Secondary	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).	Less than 6 months since the first injury
Secondary	Number of adverse effects	Any reaction with the product injected	Through study completion, an average of 1 year