1. Home
  2. Approved trials
  3. » فارسی

The effects of platelet lysate therapy on cuff tendinopathy

Protocol summary

Study aim
Effect of platelet lysate on cuff tendinopathy
Design
This study is not-blind, phase 3 clinical trials on 40 patients based on inclusion and exclusion criteria, the study procedure will be explained to patients, and informed consent will be obtained before the study and classified into two groups of PL and control group without any treatment.
Settings and conduct
The following items for the patients who are most relevant, recorded: 1) Pain by visual analog scale (VAS) 2) Cuff function by the Shoulder Pain and Disability Index (SPADI) 3) Cuff motion range by joiniometry. After PL and quality control, patients will be referred to the Rehabilitation and Physical Medicine Department of the Shahid Madani Hospital for the injection of PL in the cuff. A second injection is repeated at intervals of 21 days. Then, in order to evaluate the effect of PL on patients in the intervals of 1 and 3 months after the first injection, the cases mentioned above will be recorded.
Participants/Inclusion and exclusion criteria
A total of 40 Men and women between the ages of 18 and 75 with cuff tendinopathy and exclusion criteria Pregnant women or women who are breastfeeding, People with malignancy, hemorrhagic diseases, history of anemia, History of cuff surgery in the last 3 months
Intervention groups
Platelet lysate (PL) treatment group , which will be injected 2 cc of PL in the shoulder tendon area and Its effectiveness will be assessed in 1 to 3 months after the first injection. In control group without any treatment, patients' condition will be assessed in 1 and 3 months after the beginning of the study
Main outcome variables
1- Determining cuff pain by VAS in all phases of clinical trial 2- Determination of cuff function by Shoulder Pain and Disability Index (SPADI) in all phases of clinical trial 3- Determine the range of cuff motion by manual joiniometry in all phases of the trial

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160422027520N17
Registration date: 2020-04-14, 1399/01/26
Registration timing: prospective

Last update: 2020-04-14, 1399/01/26
Update count: 0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of platelet lysate therapy on cuff tendinopathy
Public title
Treatment of cuff tendinopathy with platelet lysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between the ages of 18 and 75 with cuff tendinopathy The availability of individual during the study period
Exclusion criteria:
People under the age of 18 and over 75 years Pregnant women or women who are breastfeeding People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome Those linked to acetaminophen or Vicodin or a history of drug misuse History of cortisone injections in the last 6 weeks The use of non-steroidal anti-inflammatory drugs 1 week ago Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ The use of inhibitors of platelet aggregation and anti-coagulation such as heparin History of cuff surgery in the last 3 months
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.TBZMED.REC.1398.1133

Health conditions studied

1

Description of health condition studied
Cuff tendinopathy
ICD-10 code
M75.101
ICD-10 code description
Unspecified rotator cuff tear or rupture of right shoulder, not specified as traumatic

Primary outcomes

1

Description
Determining cuff pain by VAS in all phases of clinical trial
Timepoint
1 and 3 months after the first injection
Method of measurement
Questionnaire (VAS)

2

Description
Determination of cuff function by Shoulder Pain and Disability Index (SPADI) in all phases of clinical trial
Timepoint
1 and 3 months after the first injection
Method of measurement
Questionnaire (SPADI)

3

Description
Determine the range of cuff motion by manual joiniometry in all phases of clinical trial
Timepoint
1 and 3 months after the first injection
Method of measurement
Range of motion (Degree)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group of patients, 10 ml of blood will be taken by PRP-specific syringe manufactured by Noavaran Salamat Arjang CO. and according to kit protocol, we will separate the PRP and then produce Platelet lysate. The Platelet lysate will then be injected by a physician into the cuff tendon of the patient with cuff tendinopathy. The Platelet lysate injection volume will be 2 cc.The injection will be repeated with a 21 days apart.
Category
Treatment - Drugs

2

Description
Control group: No drugs will be injected into patients in this group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Hospital, Tabriz
Full name of responsible person
Mehdi Yousefi, Ph.D Of Medical Immunology
Street address
Shahid Madani Hospital, Golbad Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7767
Email
mehdi_yusefi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Street address
Tabriz University of Medical Seciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Tabriz University of Medical Sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1336 4665
Fax
Email
yousefime@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Tabriz University of Medical Sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1336 4665
Fax
Email
yousefime@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology, Tabriz University of Medical Sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1336 4665
Fax
Email
yousefime@tbzmed.ac.ir
Web page address

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
Loading...