Platelet-Rich Plasma in Acute Muscle Injuries

Phase 2

Completed

• Conditions: Muscle Injury

• Registration Number: NCT03676205
• Lead Sponsor: University of the Basque Country (UPV/EHU)

Brief 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.

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 Timeline

• Study Start: 2016-10-03
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-16
• Study First Posted: 2018-09-18
• Primary Completion: 2019-04-08
• Status Verified: 2020-01
• Study Completion: 2020-01-08
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	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).
Return to play (recovery period)	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

Secondary Outcome Measures

Name	Time	Method
Number of adverse effects	Through study completion, an average of 1 year	Any reaction with the product injected
Incidence of Recurrences	Less than 6 months since the first injury	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).

Trial Locations

Locations (1)

Javier Gonzalez Iglesias; 🇪🇸 Bilbao, Bizkaia, Spain