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IRCT20170821035817N1 IRCT 2017-12-17 Mashhad University of Medical Sciences Effect of bitter almond oil in treatment of knee arthrosis Comparison of the effectiveness of Amygdalus communis var. amara oil with placebo, diclofenac and massage in improving joint pain and stiffness and physical function in knee osteoarthritis patients 2018-04-21 anticipated 200 Complete https://irct.ir/trial/26951 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with computer generated random numbers table and sequentially numbered containers each representing a block consisting of four patients are used for the treatment assignments, Blinding description: Three different persons generate the random allocation sequence, enroll the participants and assign them to intervention groups. These persons, care providers, outcome assessors, data analyzer, investigators and participants are blinded to assignment to the bitter almond oil, diclofenac and placebo groups. Participants and care providers are not blinded to assignment to the massage group. But, all others are blinded to assignment to the massage group. 3 Osteoarthritis. Intervention 1: Fifty patients apply topical bitter almond oil to the knee every 8 hours for 10 minutes during 1 month. Intervention 2: Fifty patients apply topical diclofenac to the knee every 8 hours for 10 minutes during 1 month. Intervention 3: Fifty patients massage the knee without application of any topical agent every 8 hours for 10 minutes during 1 month. Intervention 4: Fifty patients apply topical placebo to the knee every 8 hours for 10 minutes during 1 month. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD are to be shared. When: Access period starting 6 months after publication for 1 year To whom: Researchers working in university and scientific and industrial institutes Conditions: Only statistical analyses mentioned in the article resulting from the study for personal knowledge are permitted. Written request for access to data and documents and its aim must be certified by the highest ranking official of the work place of the requester. Where to obtain: Dr. Saeed Kianbakht with the address ACECR Institute of Medicinal plants, P.O. Box: 31375-369, Iran How to obtain: Written request should be sent to the address Dr. Saeed Kianbakht, ACECR Institute of Medicinal Plants, P.O. Box: 31375-369, Iran. The documents or data file will be sent to the requester by email. Comments:
public Dr. Saeed Kianbakht
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
Karaj Iran (Islamic Republic of) 3365166571 +98 26347640109 kianbakht@imp.ac.ir ACECR Institute of Medicinal Plants scientific Dr. Ali Khorsand Vakilzadeh
Emam Reza Hospital, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51385430319 khorsanda@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Male or female patients with 1 or 2 knees osteoarthritis according to the American College of Rheumatology criteria after physical examination and knee joint radiography Age of 40 to 85 years Flare of the disease after oral non-steroidal anti-inflammatory drug or acetaminophen discontinuation which have been used at least 3 days a week during the past month (flare means increase of at least 2 scores in the total pain subscale score in the beginning of the study.) Western Ontario and McMaster Universities (WOMAC) pain subscale index at least 9 out of 20 in the beginning of the study 40 years 85 years Both Secondary osteoarthritis (due to a definite disease) Arthroscopy Knee surgery History of knee replacement surgery Infection Cardiovascular disease Hepatic disease Renal disease Other chronic inflammatory disease History of alcohol abuse History of drug abuse History of narcotic abuse Skin disease in the knee area Fibromyalgia Debilitating disease affecting the knee Pregnant women Women planning pregnancy Lactating women M19.9 Arthrosis, unspecified Treatment - Drugs Treatment - Drugs Treatment - Other Placebo Fifty patients apply topical bitter almond oil to the knee every 8 hours for 10 minutes during 1 month Fifty patients apply topical diclofenac to the knee every 8 hours for 10 minutes during 1 month Fifty patients massage the knee without application of any topical agent every 8 hours for 10 minutes during 1 month Fifty patients apply topical placebo to the knee every 8 hours for 10 minutes during 1 month Extent of arthritis. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire. Extent of joint stiffness. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire. Extent of joint pain. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire. Extent of physical function. Timepoint: Before intervention and 1 month after intervention. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index questionnaire. Iranian academic center for education culture and research Mashhad University of Medical Sciences Iranian academic center for education culture and research Approved 2017-07-15 Ethics committee of Mashhad University of Medical Sciences Building of Mashhad University of Medical Sciences, Shahid Fakuri Boulevard, Danesh Salamat Town Mashhad Razavi Khorasan Iran (Islamic Republic of)