Effect of Topical Application of Nigella Sativa Oil and Oral Acetaminophen on Pain in Elderly with Knee Osteoarthritis: A Crossover Clinical Trial.
BACKGROUND
Limited evidence supports Nigella sativa's role as an effective complementary and alternative medicine and the anti-inflammatory effects of Nigella sativa on patients with allergic rhinitis.


OBJECTIVE
The aim of this study was to investigate the effect of topical application of Nigella sativa oil and oral acetaminophen on pain in the elderly with knee osteoarthritis residing in a parents' home in Sabzevar.


METHODS
This study is done as a crossover clinical trial. After obtaining written consent of elderly patients with osteoarthritis of the knee, they were randomly divided into two groups. In step 1, in group 1, 1 cc of Nigella sativa oil was applied on the knee joint every 8 hours for 3 weeks; for the second group, every 8 hours for 3 weeks, patients were given 1 tablet of 325 mg acetaminophen. After a period of 1 month without medication to wash out each group, in step 2, each treatment group received the drug interaction in the same way as above. Pain was determined using a visual scale (VAS) before and after the first and second stages. Treatment response was defined as a decrease in pain scores over 1.5. Data analysis was performed with an R software mixed model.


RESULTS
This study was done on 40 elderly patients: 18 (45%) men and 22 (55%) women. Their mean year and weight were 75.66±8.9 years and 69.67±14.33 kg, respectively. Study results showed that topical application of Nigella sativa oil and oral acetaminophen reduced pain in elderly with knee osteoarthritis; after using Nigella sativa oil, the reduction of pain was higher (p=0.01).


CONCLUSIONS
The results of this study showed that topical application of Nigella sativa oil was effective in reducing pain in patients with knee osteoarthritis; therefore, it is recommended as a safe supplement for these elderly.


BACKGROUND
The trial was registered at TCTR (http://www.clinicaltrials.in.th/) with the ID: TCTR20160125003.


BACKGROUND
This study was approved and supported by the Sabzevar University of Medical Sciences.
Ph.D. of Nutrition, Associate Professor, Department of Nutrition & Biochemistry, Faculty member of Medicine school, Sabzevar University of Medical Sciences, Sabzevar, Iran.
Akram
A
Kooshki
MD, Management of Treatment, Sabzevar University of Medical Sciences, Sabzevar, Iran.
Reza
R
Forouzan
Ph.D. OF Biostatistics, Assistant Professor, Department of Biostatics, Faculty member of Health School, Sabzevar University of Medical Sciences, Sabzevar, Iran.
Mohammad Hassan
MH
Rakhshani
Ph.D. of Health Education, Assistant Professor, Department of Public Health, Faculty Member of Health School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Maryam
M
Mohammadi
Elderly; Nigella sativa oil; Osteoarthritis; Pain