Protocol summary
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Study aim
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Evaluation of efficacy of intra articular injection of mannitol versus hypertonic dextrose prolothrapy on decreasing pain and improvement of function in patients with knee osteoarthritis randomize clinical trial
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Design
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This research is a randomized double-blind, controlled clinical trial
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Settings and conduct
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The patient select from emam reza clinic and rajaee hospital who has knee osteoarthritis.then patient divided into two groups and after obtaining written consent the study begins. in control group hypertonic dextrose is injected and in intervention group monitol is injected then we measure its effect on reducing pain and improving patient function
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: aged 38 to75 years; both genders; knee radiography anterior standing view have been for the last one month; have symptoms of osteoarthritis include pain, crepitation, and knee joint dryness for at least a month without any extra-articular involvement; any injection of the knee joint during the last three of months.
Exclusion criteria: sensitivity reaction to test drug; the patient has done total knee arthroplasty; the patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy; diseases such as rheumatoid arthritis, Reiter's syndrome, gout; uncontrolled diabetes, HBA1c more than7.5, BMI more than 40; history of knee trauma, fracture
patient's mental disorder.
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Intervention groups
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Intervention group:group that receive knee intra articular injection of mannitol
control group: group that receive knee intra articular injection of hypertonic Dextrose.
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Main outcome variables
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pain, Activity of daily living
General information
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Reason for update
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wrong translation
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190912044756N1
Registration date:
2020-08-24, 1399/06/03
Registration timing:
registered_while_recruiting
Last update:
2022-02-13, 1400/11/24
Update count:
2
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Registration date
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2020-08-24, 1399/06/03
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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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2020-05-20, 1399/02/31
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Expected recruitment end date
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2020-12-20, 1399/09/30
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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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Evaluation of efficacy of intra articular injection of mannitol versus hypertonic dextrose prolotherapy on decreasing pain and improvement of functions in patients with knee osteoarthritis
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Public title
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Evaluation of efficacy of intra articular injection of mannitol in patient with knee osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age: 38 to70 years old
Gender: male or female
Knee radiography anterior standing view have been for the last three month
Have symptoms of osteoartritis include pain, crepitation for at least a month without any extra articular involvment
Exclusion criteria:
Any injection of the knee joint during the last three of months
sensitivity reaction to test drug
The patient have done total knee arthroplasty
The patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy
Diseases such as rheumatoid arthritis, Reiter's syndrom, gout
Uncontrolled diabetes,HBA1c more than7.5, BMI more than 40
History of knee trauma,fracture
Patient's mental disorder
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Age
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From 38 years old to 75 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
- Data analyser
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Sample size
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Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
If both knee are involve,one kneeis in the intervention group and the other is in the control group
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Complete randomize block design with SSPP software is used for randomization and then sealed non-transparent envelopes are used to hide the random sequence
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participant: The participant is explained that if they are interested, they can
join our research project. two methods used to reduce patient pain input study are explained to the patient. Benefits and possible complications of both methods are described to the patient and the patient is told to randomly fall into one of the intervention groups. If the patient is accepted to admit the study, by random allocation soft ware, the patient falls in to one of two groups.
Clinical car giver: we teach the caregiver how to complete the questionnaier. This person is not aware of receiving patient intervention.
Researcher: In this study does not have the ability to blind the reseacher because the researcher performs both intervention himself and is aware of receiving each intervention in the group.
The outcome assessor of the complete questionnaires is given to person who is not aware of the interventions performed and he/she is asked to determine the level of performance in each person according to the questionnaires.
Date analyzer: questionnaire are finally given to a person to review the information. This person doesn't know any of the steps of the work, how to classify and the intervention performed.
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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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2019-07-28, 1398/05/06
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Ethics committee reference number
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IR.SUMS.MED.REC.1398.314
Health conditions studied
1
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Description of health condition studied
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Osteoarthritis of knee
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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knee pain
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Timepoint
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Two weeks ,foure weeks, eight weeks
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Method of measurement
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Visual Analogue Scale
Secondary outcomes
1
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Description
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Function of patient
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Timepoint
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two weeks, four weeks, eight weeks
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Method of measurement
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Oxford knee score
Intervention groups
1
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Description
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Intervention group: the group that receive 5cc mannitol 5%, knee intra articular injection ,in three doses as the first dose and two weeks, four weeks , weeks after first dose and control group that receive 5cc of dextrose 25%,inter articular injection,as sequence of intervention group.
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Category
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Rehabilitation
2
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Description
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Control group: group who received knee intra articular injection of hypertonic dextrose
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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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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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All available data can be shared after making people unidentifiable.
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When the data will become available and for how long
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Start access period one year after publishing the results.
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To whom data/document is available
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everyone can access to this information.
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Under which criteria data/document could be used
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if the information in this study helps to improve the science process.
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From where data/document is obtainable
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dr.nasrin.barzegar1975@gmail.com 00989173092357
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What processes are involved for a request to access data/document
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After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of three weeks if permitted.
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Comments
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