Comparison between the efficacy of ultrasound-guided dextrose 25% hypertonic prolotherapy and intraarticular normal saline injection on pain, functional limitation and range of motion; in knee osteoarthritis patients

Comparison of the effect of 25% hypertonic dextrose prolotherapy injection under ultrasound guidance with intra-articular injection of normal saline under ultrasound guidance in patients with chronic knee pain referred to Shiraz medical science training centers in improving pain and function and knee range of motion

double-blind randomized clinical trial with a control group

The patient select from emam reza clinic and rajaee hospital who has knee OA.then patient divided into two groups and after obtaining written consent the study begins. in intervention group hypertonic dextrose is injected and in control group normalsaline is injected then we measure its effect on reducing pain and improving patient function and knee range of motion

The entry conditions include the age of the patients, patients 55-75 years old with pain or limitation of the range of motion of the knee for more than three months. Gender: male or female. Anterolateral knee x-ray taken in the last 3 months while standing. exclusion conditions: patients with inflammatory diseases and vascular collagen such as lupus and suspicion of knee infection, patients with coagulation disorders, patients with active lumbosacral radiculopathy and severe deformity of the spine and lower limbs, nervous system disorders, being pregnant , diabetes, A history of surgery on the knee, injection CS in the last two months, or intra-articular injection of hyaluronic acid in the last 12 months, or replacement of the knee joint, use of opioid drugs, body mass index above 40 should not be included in the study.

Intervention group: The group that received 25% dextrose medicine intra-articularly in the knee. Control group: The group that receives normal saline intra-articularly.

Pain, Activity of daily living, knee range of motion

To match patients in the intervention and control groups, patients are randomly assigned to one of two treatment groups. The random allocation method in this study will be the permutation blocks randomization method with 4 samples in each block and a random list of data will be obtained by using Random Allocation software. We will have two lists of 25patients, including the two intervention and control groups, at random. For concealment, method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by a person unaware of the division of groups

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.

All available data can be shared after making people unidentifiable.

Start access period one year after publishing the results.

everyone can access to this information.

if the information in this study helps to improve the science process.

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