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General information
2024-04-20, 1403/02/01
2024-06-21, 1403/04/01
2024-0406-2021 00:00:00
2024-09-20, 1403/06/30
2024-12-20, 1403/09/30
2024-0912-20 00:00:00
empty
The information of the start and end of sampling was not recorded correctly and it was corrected.
The information of the start and end of sampling was not recorded correctly and it was corrected.
empty
اطلاعات شروع و پایان نمونه گیری به درستی ثبت نشده بود و آن اصلاح شد.
اطلاعات شروع و پایان نمونه گیری به درستی ثبت نشده بود و آن اصلاح شد.
Recruitment centers
#1
Name of recruitment center - English: Medical centers affiliated to Kerman University of Medical Sciences
Name of recruitment center - Persian: مراکز درمانی وابسته به دانشگاه علوم پزشکی کرمان
Full name of responsible person - English: tahereh rezaeian
Full name of responsible person - Persian: طاهره رضاییان
Street address - English: Haft Bagh, Kerman University of Medical Sciences
Street address - Persian: هفت باغ دانشگاه علوم پزشکی کرمان
City - English: kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913555
Phone: +98 34 3132 5700
Fax:
Email: tahere.rezaiyan@gmail.com
Web page address:
Name of recruitment center - English: Medical centers affiliated to Kerman University of Medical Sciences
Name of recruitment center - Persian: مراکز درمانی وابسته به دانشگاه علوم پزشکی کرمان
Full name of responsible person - English: Tahereh Rezaeian
Full name of responsible person - Persian: طاهره رضاییان
Street address - English: Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
Street address - Persian: شهر کرمان، میدان هفت باغ، دانشگاه علوم پزشکی کرمان
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913555
Phone: +98 34 3132 5700
Fax:
Email: tahere.rezaiyan@gmail.com
Web page address:
Name of recruitment center - English: Medical centers affiliated to Kerman University of Medical Sciences Name of recruitment center - Persian: مراکز درمانی وابسته به دانشگاه علوم پزشکی کرمان Full name of responsible person - English: tahereh rezaeianTahereh Rezaeian Full name of responsible person - Persian: طاهره رضاییان Street address - English: Haft Bagh, Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town Street address - Persian: شهر کرمان، میدان هفت باغ، دانشگاه علوم پزشکی کرمان City - English: kermanKerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7616913555 Phone: +98 34 3132 5700 Fax: Email: tahere.rezaiyan@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abedin Iranpour
Full name of responsible person - Persian: عابدین ایرانپور
Street address - English: Haft Bagh, Kerman University of Medical Sciences
Street address - Persian: هفت باغ دانشگاه علوم پزشکی کرمان
City - English: kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913555
Phone: +98 34 3226 3855
Fax:
Email: a.iranpour@kmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abedin Iranpour
Full name of responsible person - Persian: عابدین ایرانپور
Street address - English: Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
Street address - Persian: شهر کرمان، میدان هفت باغ، دانشگاه علوم پزشکی کرمان
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616913555
Phone: +98 34 3226 3855
Fax:
Email: A.iranpour@kmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Abedin Iranpour Full name of responsible person - Persian: عابدین ایرانپور Street address - English: Haft Bagh, Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town Street address - Persian: شهر کرمان، میدان هفت باغ، دانشگاه علوم پزشکی کرمان City - English: kermanKerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7616913555 Phone: +98 34 3226 3855 Fax: Email: a.iranpourA.iranpour@kmu.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the effect of platelet-rich plasma and knee mobilization techniques and dry needling in knee osteoarthritis patients
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, is performed on 76 patients. Block randomization is used for randomization.
Settings and conduct
Knee osteoarthritis patients are evaluated for the presence of TRPs in lumbar and knee muscles in the Kerman University of Medical Sciences. Then, they are randomly divided into 4 treatment groups of control, PRP, knee mobilization and dry needling, and combination of both interventions according to block randomization. The two-blind study will be conducted in such a way that patients are evaluated by people who are unaware. Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.
Participants/Inclusion and exclusion criteria
Patients with the age range of 45 to 70 years had symptoms of moderate osteoarthritis and at least one trigger point in the hip and knee muscles. Patients with severe inflammation of the knee, any previous fracture of lower limb, were excluded from the study.
Intervention groups
PRP: 5 mL of PRP is slowly injected into the knee via an infero-medial or infero-lateral route with a 21-gauge needle. This technique is performed once for both knees in patients. Dry needling (DN): It is used on the trigger point in the TFL, adductor, hamstring, quadriceps, gastrocnemius, and popliteus muscles. The needle is applied for three sessions. Knee mobilization: It is used to increase the range of motion of flexion and extension in the knee joint. Control group: the therapist applies soft and superficial massage on the involved muscles. The fingertips of each therapist's hand are placed in contact with the related muscles and a surface massage is performed.
Main outcome variables
Pain intensity, Disability Index, Range of motions
General information
Reason for update
The information of the start and end of sampling was not recorded correctly and it was corrected.
Acronym
PRP(platelet-rich plasma)
IRCT registration information
IRCT registration number:IRCT20240211060958N1
Registration date:2024-05-15, 1403/02/26
Registration timing:prospective
Last update:2024-08-01, 1403/05/11
Update count:1
Registration date
2024-05-15, 1403/02/26
Registrant information
Name
tahereh rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5367
Email address
tahere.rezaiyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of platelet-rich plasma and knee mobilization techniques and dry needling in knee osteoarthritis patients
Public title
Effect of platelet-rich plasma and knee mobilization techniques and dry needling in knee osteoarthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients were between the ages of 45 and 70 years old
The presence of moderate osteoarthritis symptoms (grade 2-3 of the Kellgren-Lawrence classification system)
The presence of trigger point (latent or active) in the muscles around the hip and knee joints.
Exclusion criteria:
Patients with severe inflammation/swelling of the knee
Any history of injection/aspiration of the knee joint during the last year
Any previous fracture of the spine or lower limbs
Associated neurological pathology
Vestibular disorders
Systemic disease (rheumatoid arthritis or diabetes)
Patients with blood disorders (such as hemophilia or thalassemia), cancer, or if they are taking taking anticoagulants drugs
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
76
More than 1 sample in each individual
Number of samples in each individual:
19
19 subjects per group
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization: It works by randomizing participants within blocks such that an equal number are assigned to each treatment. For example, given a block size of 10, there are 8 possible ways to equally assign participants to a block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind study will be done, in this way, the allocation of people to the groups and the assessment of patients are done by people who are unaware of the status of the grouping of patients. Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.KMU.REC.1402.344
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee
Primary outcomes
1
Description
1.Pain intensity
Timepoint
Before, After and 2month follow up
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Knee disability index
Timepoint
Before, After and 2month follow up
Method of measurement
WOMAC questionnaire and KOOS questionnaire
2
Description
Knee range of motion
Timepoint
Before, After and 2month follow up
Method of measurement
Goniometer
Intervention groups
1
Description
Intervention group: dry needling and knee mobilization
Category
Rehabilitation
2
Description
Intervention group: platelet-rich plasma
Category
Treatment - Other
3
Description
Control group: placebo
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers affiliated to Kerman University of Medical Sciences
Full name of responsible person
Tahereh Rezaeian
Street address
Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
tahere.rezaiyan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
A.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Tahereh Rezaeian
Position
Assistant Professor of Kerman University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
tahere.rezaiyan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Tahereh Rezaeian
Position
Assistant Professor of Kerman University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
Tahere.rezaiyan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Tahereh Rezaeian
Position
Assistant Professor of Kerman University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kerman University of Medical Sciences, Haft Bagh Square, Kerman Town
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
Tahere.rezaiyan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the data, such as information about the consequences, can be shared
When the data will become available and for how long
Starting the access period: 6 months after publiton the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Only statistical analyzes can be used to find treatment for improvement of patients
From where data/document is obtainable
Applicants can be guided by email's responsible author.
(tahere.rezaiyan@gmail.com)
What processes are involved for a request to access data/document
First, they will email the responsible author of the study and we Will be answered within a week.(Applicants can be guided by email's responsible author.
tahere.rezaiyan@gmail.com)