Protocol summary
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Study aim
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Comparison of the effects of the combination of platelet-rich plasma and laser therapy against the combination of platelet-rich plasma, laser therapy and exercise therapy on pain intensity, disability, and quality of life in patients with knee osteoarthritis.
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Design
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a clinical trial with a control group, parallel groups, triple-blind, randomized, phase 3 on 72 patients.
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Settings and conduct
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First, 72 qualified patients who refer to nab pain Clinic are selected. Then they are randomly divided into intervention and control groups using permutation block method. The control group will receive PRP intervention and laser therapy. In addition to PRP and laser therapy, the intervention group will also receive exercise therapy.
By using researcher assistants and analysts outside the research team, the data collector and analyst will be blind.
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Participants/Inclusion and exclusion criteria
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1.Mild to moderate osteoarthritis (OA) (2 or 3)
2.No inflammatory, bleeding disorders and rheumatoid arthritis
3.No rheumatoid disease
4.No endocrine and metabolic diseases
5.No imbalance and limping
6.No pregnancy
7.Not perform procedures such as Arthrocentesis in the last six months
8.No joint surgery last year
9.Willingness to participate in the study
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Intervention groups
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PRP and laser therapy Group:
In this group, PRP will be injected five times at a dose of 3 ml into the patient's knee (two weeks apart). Also, in this group, high-level laser therapy is performed for three weeks (3 times a week).
PRP, laser therapy and exercise therapy group:
In addition to PRP injection (five times at a dose of 3 ml, two weeks apart) and laser therapy (3 times a week for three weeks) ,this group will receive exercise therapy intervention three times a week for three weeks (10-20 minutes each time).
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Main outcome variables
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Pain intensity, disability and quality of life
General information
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Reason for update
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According to the reviewer's opinion, some modifications were made in the study method.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201001048893N4
Registration date:
2022-07-03, 1401/04/12
Registration timing:
prospective
Last update:
2024-07-26, 1403/05/05
Update count:
1
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Registration date
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2022-07-03, 1401/04/12
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-08-21, 1403/05/31
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Expected recruitment end date
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2025-08-22, 1404/05/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effects of a combination of platelet-rich plasma and laser therapy versus a combination of platelet-rich plasma, laser therapy, and exercise therapy on pain intensity, disability, and quality of life in patients with knee osteoarthritis: a clinical trial study
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Public title
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Comparison of the effects of a combination of platelet-rich plasma and laser therapy versus a combination of platelet-rich plasma, laser therapy, and exercise therapy on pain intensity, disability, and quality of life in patients with knee osteoarthritis: a clinical trial study
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Mild to moderate osteoarthritis (OA) (2 or 3) as diagnosed by an orthopedic surgeon based on the Kellgren-Lawrence Grading Scale (KL)
No inflammatory and bleeding disorders
No rheumatoid arthritis
No endocrine and metabolic diseases
Imbalance and limping
No pregnancy
not perform procedures such as Arthrocentesis in the last six months
No joint surgery last year
Willingness to participate in the study
Exclusion criteria:
Failure to complete the course of treatment
Participant withdrawal from the study
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, using randomization software by someone outside the study, patients will be placed in two groups of combination of platelet-rich plasma and laser therapy and group of combination of platelet-rich plasma, laser therapy and exercise therapy.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study, to blind and prevent possible bias, dividing patients into two groups, interviewing patients to complete the questionnaire, interpreting the questionnaire, entering and interpreting data, and analyzing information in statistical software will be done by nurses and statistics outside the study. Participating patients also do not know how to allocate other patients to another group. In other words, the patients will not know about the treatment and the type of intervention of other patients in the other group. moreover, the data analyzer will not be aware of the grouping of patients, and only the physician performing the injection will be aware of the assignment of individuals to the groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-11, 1400/09/20
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Ethics committee reference number
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IR.SUMS.NUMIMG.REC.1400.072
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis
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ICD-10 code
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M17. 9
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ICD-10 code description
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Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting i
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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Before treatment and 1, 3, and 6 months after treatment
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Method of measurement
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Numerical Rating Scale (NRS)
Secondary outcomes
1
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Description
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Disability
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Timepoint
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Before treatment and 1, 3, and 6 months after treatment
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Method of measurement
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
2
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Description
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Quality of life
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Timepoint
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Before treatment and 3, and 6 months after treatment
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Method of measurement
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36-Item Short Form Survey (SF-36)
Intervention groups
1
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Description
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The first intervention group: In this group, PRP injection will be done five times in the amount of 3 ml (two weeks apart) in the patient's knee. The centrifuge device manufactured by Navaran Salamat Arjang company (Tehran/Iran) is used to prepare PRP. To perform PRP, first 10 ml of blood will be taken from the patient's vein and with 1 ml of sodium citrate 13.3% using a kit prepared by Navaran Salamat Arjang Company (approved by the Ministry of Health - Tehran, Iran) ) will be mixed and the first centrifugation is performed (5 minutes at a speed of 1600 rpm). Then the red blood cells will be removed. In order to concentrate the platelets, the remaining material is centrifuged again (6 min at 1200 rpm). The final product will be 3 ml of PRP containing leukocytes. It should be noted that an exogenous agent will not be used for the activation process and the direct contact of platelets with joint collagen will help to activate it. The skin of the injection site is prepared and covered, and the PRP injection will be done in a sitting position and under sterile conditions with the classical method of intra-articular injection below and outside the patella by a specialist doctor who is a member of the research team. PRP injection will be done five times in the amount of 3 ml (two weeks apart) in the patient's knee. Also, in this group, high-level laser therapy for three weeks (3 times a week) at 4 to 8 G (Joules per treatment spot) with a wavelength of 785-860 nm and at 1-3 J (Joules per treatment spot) with a wavelength of 840 in each treatment spot. PRP and laser therapy are performed in all patients by a specialist doctor who is a member of the research team.
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Category
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Treatment - Other
2
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Description
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The second intervention group: For this group, like the other group, PRP injection will be done five times in the amount of 3 ml (two weeks apart) in the patient's knee. Also, like the other group, in this group, high-level laser therapy for three weeks (3 times a week) at 4 to 8 G (Joules per treatment spot) with a wavelength of 785-860 nm and at 1-3 G (Joules per treatment spot) with a wavelength of 840 is done in each treatment spot. In this group, in addition to PRP and laser therapy, exercise therapy will be performed 3 times a week for 3 weeks for 10 to 20 minutes each time. Exercises will include range of motion exercises (passive, active and active assistance), progressive resistance exercises, balance, strength, and aerobic exercises. PRP, laser therapy, and exercise therapy will be performed in all patients by a specialist doctor who is a member of the research team. In order to prevent data contamination, interventions will be offered to patients of each group on different days, and patients will be present at the clinic on specific days with prior coordination and receive their respective intervention.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Anonymous study data will be shared in correspondence with the project manager.
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Systematic reviews and meta-analyses
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From where data/document is obtainable
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Contact via email: m2620.shaygan@gmail.com
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What processes are involved for a request to access data/document
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After receiving the official request for data, the executor of the project sends the request to the Security Unit and the Vice Chancellor for Research of Shiraz University of Medical Sciences and in case of obtaining permission to provide data, the data will be provided to the person within a period of approximately 1 month.
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Comments
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