Comparison of the effect of platelet-rich plasma (PRP) with physiotherapy on pain and muscle damage and Returning to Sport in athletes with groin adductor muscle injury.
Determining the effect of PRP or platelet rich plasma compared to physiotherapy on pain relief and the average time to return to sports in athletes with groin adductor muscle damage.
Design
The clinical trial has a control group, with parallel groups, the sampling and randomization method is in the form of random numbers, so according to the sample size of twenty, twenty pieces of paper are randomly divided into two groups A and B, and each individual which enters the study, faces from the envelope of random numbers of group A or B. Randomized, phase 2 on 100 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The place of the study is the sports medicine clinic of Imam Khomeini Hospital, which was conducted in 1400. The clinical trial includes athletes with adductor muscle tears. The duration of follow-up is 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Patient consent to enter the study.
2. Second and third degree acute injury of the adductor muscle (based on ultrasound evidence)
3. No injury in other muscles around the pelvis (examination, history, ultrasound)
Exit criteria
1. Failure to do corrective exercises
2. Absence of more than three physiotherapy sessions (17)
Intervention groups
The group that receives PRP injection and undergoes rehabilitation after the injection
Main outcome variables
pain relief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221218056850N1
Registration date:2023-04-18, 1402/01/29
Registration timing:registered_while_recruiting
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
romisa majdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
romisa.majdi2019@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-05-19, 1402/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of platelet-rich plasma (PRP) with physiotherapy on pain and muscle damage and Returning to Sport in athletes with groin adductor muscle injury.
Public title
Comparison of the effect of platelet-rich plasma (PRP) with physiotherapy on pain and muscle damage and Returning to Sport in athletes with groin adductor muscle injury.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to enter the study
Second and third degree acute injury of the adductor muscle (based on ultrasound evidence)
No injury in other muscles around the pelvis (examination, history, ultrasound)
Exclusion criteria:
Failure to perform corrective exercises
Absence of more than three physiotherapy sessions
Desire not to continue studying
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling and randomization method is in the form of random numbers, so according to the sample size of twenty, twenty pieces of paper are randomly divided into two groups A and B, and each person who enters the study is drawn from the envelope of random numbers of group A. or it leads to b.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
No. 1, University of Medical SciencesImam Khomeini Square, Joibar Street, Building
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.MAZUMS.REC.1401.554
Health conditions studied
1
Description of health condition studied
groin pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Average time to return to activity
Timepoint
One week after the injection and then every week up to six weeks in person, after six weeks up to two weeks by phone, after three months, they undergo a final examination again in person through a physical examination and the pain level of the patients using a VAS from zero to zero. The score is determined
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They only receive PRP injection and undergo rehabilitation after the injectionThey will only receive one PRP injection with a volume of 3 cc with a 5 cc needle in the place of muscle rupture under ultrasound guidance, and after the injection they will undergo rehabilitation.
Category
Treatment - Drugs
2
Description
Control group: The group that underwent only 14 sessions of physiotherapy with the same modalities including TENS for 20 minutes, and IF for ten minutes in trigger point mode and ten minutes in pain mode and four sessions of Dry needling on all adductor muscles for 4 sessions and ten minutes of RF machine and exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Rumisa Majdi
Street address
Amir Mazandarani Street, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
romisa.majdi2019@gmail.com
Web page address
https://www.mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rumisa Majdi
Position
Sports medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Amir Mazandarani Street, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
romisa.majdi2019@gmail.com
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rumisa Majdi
Position
Sports medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Amir Mazandarani Street, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
romisa.majdi2019@gmail.com
Web page address
https://www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rumisa Majdi
Position
Sports medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Amir Mazandarani Street, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
romisa.majdi2019@gmail.com
Web page address
https://www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available