Platelet-Rich Plasma in Acute Muscle Injuries

NCT03676205 | Completed Phase 2

• 1 other identifier: PRP-MUSCULO-2014-2019
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Injury

Keywords

Platelet-Rich Plasma; hamstrings; cuadriceps; football players

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Incidence of Recurrences

  Less than 6 months since the first injury

• Number of adverse effects

  Through study completion, an average of 1 year

Study Arms (2)

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.

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.

Other: Traumeel

Interventions

PRP BIOLOGICAL

Platelet-Rich Plasma

Platelet-Rich Plasma

Traumeel OTHER

Homeophatic Treatment

Traumel ®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old.
• Acute muscular Injury Type 3a-3b (Múnich classification) in hamstring muscles
• Informed consent signed

You may not qualify if:

• Hamstring injury (last 6 months).
• Previous infiltration in hamstring.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

Javier Gonzalez Iglesias

Bilbao, Bizkaia, 48415, Spain

Location

Related Publications (1)

• 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.

  PMID: 23885648 RESULT

MeSH Terms

Interventions

Traumeel S

Study Officials

• Javier Gonzalez Iglesias, Dr

  Basque Health System - Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient doesn't know the treatment. The person who analyze the data (outcomes assessor) doesn't know the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (orthopedic surgeon)

Model Details: Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 18, 2018
• Study Start: October 3, 2016
• Primary Completion: April 8, 2019
• Study Completion: January 8, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

ES (1)