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IRCT20211203053264N1 IRCT 2021-12-11 Bojnourd University of Medical Sciences Topical effect of tarragon oil extract on pain intensity, dryness and physical function of knee joint in patients with chronic osteoarthritis referred to Taleghani Gonbad Kavous Hospital in 1399 Topical effect of tarragon oil extract on pain intensity, dryness and physical function of knee joint in patients with chronic osteoarthritis 2021-12-18 anticipated 90 Complete https://irct.ir/trial/60390 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were randomly divided into three intervention groups (topical application of 3% tarragon oil extract), sweet almond oil group, and control group. For this purpose, a lottery was conducted with three cards. Treatment methods were marked with three ABC marks on cards and placed in a box. Then, at the time of referral, the participants with the inclusion criteria were asked to remove one card from the box, and the next person removed the remaining two cards and the third person removed the remaining card from the box, and as a result, the type of treatment for each participant was determined. , Blinding description: Patients were randomly divided into three intervention groups (topical application of 3% tarragon oil extract), sweet almond oil group, and control group. For this purpose, a lottery was conducted with three cards. Treatment methods were marked with three ABC marks on cards and placed in a box. Then, at the time of referral, the participants with the inclusion criteria were asked to remove one card from the box, and the next person removed the remaining two cards and the third person removed the remaining card from the box, and as a result, the type of treatment for each participant was determined. . The researcher then explains to the patients how to study and the details of the intervention, and explains the method of topical use of the oil to each of them. 3% tarragon oil extract with the basis of sweet almond oil and also sweet almond oil was prepared from Barij Essential Oil Company of Kashan. 3 Chronic osteoarthritis. Intervention group: Patients were randomly divided into three intervention groups (topical application of 3% tarragon oil extract), sweet almond oil group, and control group. For this purpose, a lottery was conducted with three cards. Treatment methods were marked with three ABC marks on cards and placed in a box. Then, at the time of referral, the participants with the inclusion criteria were asked to remove one card from the box, and the next person removed the remaining two cards and the third person removed the remaining card from the box, and as a result, the type of treatment for each participant was determined. . The researcher then explains to the patients how to study and the details of the intervention, and explains the method of topical use of the oil to each of them. 3% tarragon oil extract with the basis of sweet almond oil and also sweet almond oil was prepared from Barij Essential Oil Company of Kashan. The concentration of tarragon oil extract was determined based on literature review. Tarragon oil and sweet almond oil are poured into similar containers of dark opacity. The researcher then gave each participant in the group a bottle containing 40.5 cc of 3% tarragon oil and a weekly schedule. The sweet almond oil group also received a similar bottle containing 40.5 cc of sweet almonds with a weekly schedule. The intervention group applied 1.5 cc of tarragon oil extract and the sweet almond oil group applied 1.5 cc of oil (using a similar syringe or dropper) to the affected knee three times a day, daily for three weeks. In each direction, apply the inside, outside, front and back of the affected knee so that the oil covers the entire skin of the area. The control group did not receive any topical oil during the intervention. Before use, patients of almond oil and intervention groups are asked to test these oils to ensure skin sensitivity on the inside of the forearm. The researcher's contact number was also provided to the participants to contact the researcher in case of any allergies or side effects. The study was conducted in a specific chapter. In addition, in order to remind the participants how and when to perform the intervention, he reminded the participants by phone that all the participants had similar conventional drugs, including NSAIDs, acetaminophen, etc., which were prescribed by an orthopedic specialist. During the study, patients are allowed to use acetaminophen tablets at a rate of less than 2 grams per day, and patients are asked to record their daily acetaminophen use and the number of tablets to be taken at the end of the first and fourth week visits. Was recorded by the researcher. Evaluation of research and information variables was collected using WOMAC questionnaire and visual scale of VAS pain in 4 time points. The first point is the time of collection before the intervention that the questionnaire is presented to the participants. The next time points for data collection were immediately, 1 week after the intervention and 3 weeks after the intervention, which was completed by the researcher's telephone calls with the participants.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Soheila Abedpour
South Khorasan, Birjand, Ghaffari St., Birjand University of Medical Sciences - School of Nursing and Midwifery
birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 17 3322 6053 abedpur.0512@gmail.com Birjand University of Medical Sciences scientific Zahra Younesi
South Khorasan, Birjand, Ghaffari St., Birjand University of Medical Sciences - School of Nursing and Midwifery
birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3238 1400 z-unesi@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Confirmation of osteoarthritis of the knee by an orthopedic specialist Pain score ≥ 4 at least in the last 3 months based on the VAS scale People who are able to understand the description and complete the interview Written and informed consent of the person Age 30-70 years No cancer, pregnancy and blood coagulation diseases such as hemophilia No wound above the knee joint No signs of acute infection at the knee joint No serious diseases such as liver disease and kidney failure No history of gastric ulcer disease, and skin lesions in the knee area No surgery to replace the knee joint or inject intra-articular steroids 90 days before the study. Do not suffer from abnormalities related to the lower limbs 30 years 70 years Both 1- Taking oral and topical steroids for 14 days, alcoholism and drug addiction Patients with radiculopathy and neuropathy, patients with musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout and fibromyalgia) History of allergic reaction to sweet almond oil or tarragon-derived productsUse more than 2 grams per day of acetaminophen or other analgesics such as injectable drugs or other drugs such as glucosamine and chondroitin sulfate. Hospitalization Not wanting to continue participating in the study Travel and leave treatment M17 Osteoarthritis of knee Rehabilitation Intervention group: Patients were randomly divided into three intervention groups (topical application of 3% tarragon oil extract), sweet almond oil group, and control group. For this purpose, a lottery was conducted with three cards. Treatment methods were marked with three ABC marks on cards and placed in a box. Then, at the time of referral, the participants with the inclusion criteria were asked to remove one card from the box, and the next person removed the remaining two cards and the third person removed the remaining card from the box, and as a result, the type of treatment for each participant was determined. . The researcher then explains to the patients how to study and the details of the intervention, and explains the method of topical use of the oil to each of them. 3% tarragon oil extract with the basis of sweet almond oil and also sweet almond oil was prepared from Barij Essential Oil Company of Kashan. The concentration of tarragon oil extract was determined based on literature review. Tarragon oil and sweet almond oil are poured into similar containers of dark opacity. The researcher then gave each participant in the group a bottle containing 40.5 cc of 3% tarragon oil and a weekly schedule. The sweet almond oil group also received a similar bottle containing 40.5 cc of sweet almonds with a weekly schedule. The intervention group applied 1.5 cc of tarragon oil extract and the sweet almond oil group applied 1.5 cc of oil (using a similar syringe or dropper) to the affected knee three times a day, daily for three weeks. In each direction, apply the inside, outside, front and back of the affected knee so that the oil covers the entire skin of the area. The control group did not receive any topical oil during the intervention. Before use, patients of almond oil and intervention groups are asked to test these oils to ensure skin sensitivity on the inside of the forearm. The researcher's contact number was also provided to the participants to contact the researcher in case of any allergies or side effects. The study was conducted in a specific chapter. In addition, in order to remind the participants how and when to perform the intervention, he reminded the participants by phone that all the participants had similar conventional drugs, including NSAIDs, acetaminophen, etc., which were prescribed by an orthopedic specialist. During the study, patients are allowed to use acetaminophen tablets at a rate of less than 2 grams per day, and patients are asked to record their daily acetaminophen use and the number of tablets to be taken at the end of the first and fourth week visits. Was recorded by the researcher. Evaluation of research and information variables was collected using WOMAC questionnaire and visual scale of VAS pain in 4 time points. The first point is the time of collection before the intervention that the questionnaire is presented to the participants. The next time points for data collection were immediately, 1 week after the intervention and 3 weeks after the intervention, which was completed by the researcher's telephone calls with the participants. Intensity of pain. Timepoint: One week and three weeks after the intervention. Method of measurement: WOMAC questionnaire and VAS questionnaire. Joint dryness. Timepoint: One week and three weeks after the intervention. Method of measurement: WOMAC Questionnaire. Joint physical function. Timepoint: WOMAC Questionnaire. Method of measurement: One week and three weeks after the intervention. Bojnourd University of Medical Sciences Approved 2020-07-13 Birjand School of Medical Sciences and Health Services South Khorasan, Birjand, Ghaffari St., Central Organization of Birjand University of Medical Sciences Birjand South Khorasan Iran (Islamic Republic of)