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Platelet-Rich Plasma in Acute Muscle Injuries

Primary Purpose

Muscle Injury

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
PRP
Traumeel
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Injury focused on measuring Platelet-Rich Plasma, hamstrings, cuadriceps, football players

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Javier Gonzalez Iglesias

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Platelet-Rich Plasma

Traumel ®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Return to play (recovery period)
Days elapsed since muscular injury apperars until the return to play
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).

Secondary Outcome Measures

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).
Number of adverse effects
Any reaction with the product injected

Full Information

First Posted
September 13, 2018
Last Updated
January 19, 2020
Sponsor
University of the Basque Country (UPV/EHU)
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1. Study Identification

Unique Protocol Identification Number
NCT03676205
Brief Title
Platelet-Rich Plasma in Acute Muscle Injuries
Official Title
Randomized Clinical Trial About the Therapeutic Use of Platelet-Rich Plasma (PRP) for the Treatment of Acute Muscular Injuries in Football Players.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
April 8, 2019 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury
Keywords
Platelet-Rich Plasma, hamstrings, cuadriceps, football players

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two homogeneus groups with 1:1 possibilities to receive PRP or a homeopathic product.
Masking
ParticipantOutcomes Assessor
Masking Description
The patient doesn't know the treatment. The person who analyze the data (outcomes assessor) doesn't know the treatment.
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-Rich Plasma
Arm Type
Experimental
Arm Description
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.
Arm Title
Traumel ®
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
Platelet-Rich Plasma
Intervention Type
Other
Intervention Name(s)
Traumeel
Intervention Description
Homeophatic Treatment
Primary Outcome Measure Information:
Title
Return to play (recovery period)
Description
Days elapsed since muscular injury apperars until the return to play
Time Frame
average of 3-6 weeks. Until play again a football match (training or competition)
Title
Pain intensity
Description
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).
Time Frame
3 months since the injury
Secondary Outcome Measure Information:
Title
Incidence of Recurrences
Description
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).
Time Frame
Less than 6 months since the first injury
Title
Number of adverse effects
Description
Any reaction with the product injected
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Gonzalez Iglesias, Dr
Organizational Affiliation
Basque Health System - Osakidetza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Javier Gonzalez Iglesias
City
Bilbao
State/Province
Bizkaia
ZIP/Postal Code
48415
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23885648
Citation
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.
Results Reference
result

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Platelet-Rich Plasma in Acute Muscle Injuries

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