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

Comparison of the effectiveness of Amygdalus communis var. amara oil with placebo, diclofenac and massage in the treatment of knee osteoarthritis patients

Randomized; 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. Double-blind; controlled with placebo, diclofenac and massage; four group parallel design; single-center; phase 2 of clinical trial. Study population: patients with knee osteoarthritis. Sample size: 200 patients.

The trial setting: Mashhad Emam Reza Hospital. Protocol: 50 patients apply topical bitter almond oil, 50 patients apply topical placebo and 50 patients apply topical diclofenac to the knee every 8 hours for 10 minutes during 1 month and 50 patients only massage the knee without any topical agent application every 8 hours for 10 minutes during 1 month. Before intervention and 1 month after intervention the groups' extent of arthritis, extent of joint pain, extent of joint stiffness and extent of physical function are compared with each other. Blinding: 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.

Inclusion criteria: 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. Exclusion criteria: secondary osteoarthritis (due to a definite disease); arthroscopy; surgery; history of knee replacement surgery; any serious systemic disease (such as concomitant infections, cardiovascular, hepatic and renal diseases); any other chronic inflammatory disease; any history of alcohol, drug and narcotics abuse; skin disease in the knee area; having fibromyalgia and other debilitating diseases affecting the knee; pregnant women; women planning pregnancy; lactating women.

50 patients apply topical bitter almond oil, 50 patients apply topical placebo and 50 patients apply topical diclofenac to the knee every 8 hours for 10 minutes during 1 month and 50 patients only massage the knee without any topical agent application every 8 hours for 10 minutes during 1 month.

Primary outcome variable: extent of arthritis. Secondary outcome variables: extent of joint pain, extent of joint stiffness, extent of physical function.

Vice Chancellor for Research, Mashhad University of Medical Sciences; Vice Chancellor for Research, ACECR Institute of Medicinal Plants

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.

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.

All collected deidentified IPD are to be shared.

Access period starting 6 months after publication for 1 year

Researchers working in university and scientific and industrial institutes

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.

Dr. Saeed Kianbakht with the address ACECR Institute of Medicinal plants, P.O. Box: 31375-369, Iran

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.