Protocol summary
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Study aim
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Comparison of the effect of platelet-rich plasma and knee mobilization techniques and dry needling in knee osteoarthritis patients
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Design
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A clinical trial with a control group, with parallel groups, double-blind, randomized, is performed on 76 patients. Block randomization is used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pain intensity, Disability Index, Range of motions
General information
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Reason for update
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The information of the start and end of sampling was not recorded correctly and it was corrected.
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Acronym
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PRP(platelet-rich plasma)
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IRCT registration information
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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
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Registration date
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2024-05-15, 1403/02/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-06-21, 1403/04/01
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Expected recruitment end date
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2024-12-20, 1403/09/30
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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 effect of platelet-rich plasma and knee mobilization techniques and dry needling in knee osteoarthritis patients
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Public title
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Effect of platelet-rich plasma and knee mobilization techniques and dry needling in knee osteoarthritis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 45 years old to 70 years old
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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
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
76
More than 1 sample in each individual
Number of samples in each individual:
19
19 subjects per group
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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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2023-12-11, 1402/09/20
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Ethics committee reference number
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IR.KMU.REC.1402.344
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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M17.0
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ICD-10 code description
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Bilateral primary osteoarthritis of knee
Primary outcomes
1
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Description
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1.Pain intensity
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Timepoint
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Before, After and 2month follow up
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Method of measurement
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Visual analog scale
Secondary outcomes
1
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Description
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Knee disability index
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Timepoint
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Before, After and 2month follow up
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Method of measurement
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WOMAC questionnaire and KOOS questionnaire
2
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Description
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Knee range of motion
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Timepoint
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Before, After and 2month follow up
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Method of measurement
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Goniometer
Intervention groups
1
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Description
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Intervention group: dry needling and knee mobilization
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Category
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Rehabilitation
2
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Description
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Intervention group: platelet-rich plasma
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Category
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Treatment - Other
3
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Description
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Control group: placebo
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Category
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Rehabilitation
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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Kerman 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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Some of the data, such as information about the consequences, can be shared
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When the data will become available and for how long
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Starting the access period: 6 months after publiton the results
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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Only statistical analyzes can be used to find treatment for improvement of patients
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From where data/document is obtainable
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Applicants can be guided by email's responsible author.
(tahere.rezaiyan@gmail.com)
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What processes are involved for a request to access data/document
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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)
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Comments
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