The comparison of the effectiveness of dextrose prolotherapy vs. genicular nerve block in reducing pain and improving function in patients with knee osteoarthritis

Comparison of dextrose prolotherapy with genicular nerve block with alcohol in reducing pain and improving function in patients with knee osteoarthritis

The research is a randomized double blind clinical trial on 60 patients

Samples are selected from patients with knee osteoarthritis referred to Imam Reza Clinic and Rajaei Hospital and are divided into two groups. For randomization of the study, the blocked randomized method is used. after obtaining inform consent, in the control group, prolotherapy with 25% dextrose will be administered intraarticularly in 3 stages (one week apart) and in the intervention group, three branches of genicular nerves (supramedial, supralateral and inframedial) will be blocked in one stage and finally the effects on pain reduction and functional improvement will be measured

Inclusion criteria: Existence of pain and clinical signs of knee osteoarthritis and VAS score of at least 4 due to knee osteoarthritis during last month Age between 45 to 70 years old Absence of any periarticular disease around the target joint Exclusion criteria: Diabetes Mellitus Rheumatologically and collagen vascular disorders Gout Lupus Radiculopathy Nerve injuries and neuropathy Brucellosis BMI more than 42 Knee replacement on the affected side History of trauma and joint fracture Severe deformity of the lower extremities Bleeding disorders History of allergic reactions to the used drugs History of intraarticular or periarticular injections at the affected joint in the last 3 months History of significant liver, kidney and cardiopulmonary disorders Pregnancy Malignancy Use of anticoagulants

Group A undergoes intra-articular prolotherapy with 25% dextrose in 3 stages and group B under block of three branches of the genicular nerves

Pain, Activity of daily living

To match patients in the control and treatment groups, patients are randomly assigned to one of two treatment groups. The random allocation method in this study will be the permutation block randomization method, such that "A" represents the subject receiving the prolotherapy method, and "B" represents the subject who receives the genicular nerve block. This method is based on 15 blocks in 4 permutations, taking into account all possible quadruple permutations (AABB, ABAB, ABBA, BAAB, BBAA and BABA) and assigning zero to nine (according to a random number table) to each of these permutations (i.e. AABB Code 0, BABA Code 1, AABB Code 2, BBAA Code 3, BAAB Code 4, and ABBA Code 5 to 9). The method of using random table is that the 15 numbers from zero to nine (rows or columns) are randomly selected, and the assigned permutations to each number are written. (The order of placing permutations next to each other is left to right respectively) and how all 60 people will be assigned to two groups A and B, and so we will have two lists of 30 patients, including the two intervention and control groups, at random. For concealment, this method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by this person unaware of the division of groups.

Participant: At this study, we are not able to blind the patient, because patients of both groups are aware of the type of the intervention. Clinical caregiver: The caregiver is trained to complete the questionnaire and has no knowledge of the type of patient intervention. Researcher: at this study, we do not have the ability to blind the researcher, because the researcher does both studies himself and is aware of the type of intervention in each group. The impact assessor: Completed questionnaires are given to a person who is not aware of the interventions performed and he/she is asked to determine the amount of pain reduction and functional increasement in each person according to the questionnaire. Data analyzer: The questionnaires are finally given to a person to review the information after completing and collecting all the information. This person does not know any of the steps of the work and how to divide the intervention.

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

Dr. Mohammad Esmaeil ghorbani nejad 00989164168766 m_ghorbani1990@yahoo.com

after sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permitted.