]>
IRCT20170514033961N8 IRCT 2021-11-08 Khoram-Abad University of Medical Sciences "Evaluation of the effect of Leech Therapy on knee osteoarthritis" Assessment of the effect of Leech Therapy on knee osteoarthritis pain and daily functioning of the elderly 2021-10-07 anticipated 80 Complete https://irct.ir/trial/58521 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study has an intervention group and a control group for comparison, Randomization description: Samples are placed in two groups of intervention and control group using random blocks (4). The method of assigning 80 samples to the two groups of intervention and control will be such that considering gender (male_woman) and body mass index (normal category and overweight category) as a class, the method of 4 random blocks for Assigning patients to two groups A (intervention) and group B (control) will be used. The normal category is the body mass index (18.5_25) and the overweight category (25_30). To do this, in older men and women, first a list of blocks will be written and numbers will be assigned to them. - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then using a table of random numbers and randomly select numbers between 1 to 6 and finally the list of treatment assignments based on A sequence of letters A and B will be formed. Depending on the type of intervention and the awareness of the samples of the intervention they receive, blinding is not possible in the participants. But to reduce bias, we will try not to let the data collector and statistical analyst know which information belongs to which group. 2 osteoarthritis. Intervention 1: Intervention group: In addition to routine treatment, a 30-minute leech therapy session using 6 to 8 medical leeches (sankumukhi type) in a clean, secluded room while maintaining patient privacy and following all coronavirus protection protocols in a traditional medicine clinic environment will be done.Also continue your treatment routine during the intervention. Intervention 2: Control group: They will receive routine treatment and will not receive any intervention from the researcher and will be considered for comparison with the intervention group. Yes - There is a plan to make this available What will be shared: All potential data is released after unidentifiable individuals in the form of original message information When: The access period will start from 2021 To whom: Based on evidence-based medicine, if it is effective in improving the symptoms in patients with osteoarthritis of the knee, this method can be used in the clinical environment and in order to strengthen the results of previous research, we will do this research..All researchers, teachers, and medical students can download the published article from the relevant journal. Conditions: Unidentifiable data will be made available to health researchers for the study of meta-analysis. Where to obtain: Send email to Mandana Saki m.saki@modares.ac.ir How to obtain: After sending the documents by the applicant researcher via email,the data will be sent two weeks later Comments:
public Saki Mandana
No. 18, Rose Alley, Enghelab St., Khorramabad, Lorestan
Khorramabad Iran (Islamic Republic of) 6819834525 +98 66 3331 6465 mandana_saki@yahoo.com Khoram-Abad University of Medical Sciences scientific Saki Mandana
No. 18, Rose Alley, Enghelab St., Khorramabad, Lorestan
Khorramabad Iran (Islamic Republic of) 6819834525 +98 66 3331 6465 mandana_saki@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Age 60-74 (young elderly) Independence of others in daily activities Lack of neurological diseases associated with movement and balance disorders Having grade 3 (middle class) osteoarthritis according to the American College of Rheumatology classification criteria Having moderate pain based on visual analog scale with a score of (4-7) Failure to perform physiotherapy and knee surgery in the last 12 months Having satisfaction consciously to participate in the study No coagulation disorders and cardiovascular disease according to clinical history No use drugs No history of joint replacement in the lower limb No intra-articular injection of steroids in the last 6 months Having a BMI (body mass index) above 18.5 and below 30 Have a daily performance score above 34 Do not use complementary medicine methods and herbs in the field of osteoarthritis 60 years 74 years Both Occurrence of acute medical conditions such as anaphylactic shock and stroke during the study Elderly deaths during the study Withdrawal from the study despite initial agreement Sensitivity to leeches Existence of cognitive disorders based on the physician's opinion and the patient's previous medical history Secondary osteoarthritis in rheumatic diseases Use of leech therapy individually in the control group or other complementary medicine methods in both groups M17 Osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: In addition to routine treatment, a 30-minute leech therapy session using 6 to 8 medical leeches (sankumukhi type) in a clean, secluded room while maintaining patient privacy and following all coronavirus protection protocols in a traditional medicine clinic environment will be done.Also continue your treatment routine during the intervention Control group: They will receive routine treatment and will not receive any intervention from the researcher and will be considered for comparison with the intervention group. Knee pain score. Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention. Method of measurement: Osteoarthritis Index of the University of Western Ontario and McMaster. Joint dryness score. Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention. Method of measurement: Osteoarthritis Index of the University of Western Ontario and McMaster. Daily performance score. Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention. Method of measurement: Osteoarthritis Index of the University of Western Ontario and McMaster. Khoram-Abad University of Medical Sciences Approved 2021-09-04 Ethics Committee of Lorestan University of Medical Sciences Vice Chancellor for Research and Technology, Lorestan, Khorramabad, Road, Pardis University Complex University of Medical Sciences Khorramabad Lorestan Iran (Islamic Republic of)