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).

Conclusion: 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.

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

Funding: This study was approved and supported by the Sabzevar University of Medical Sciences.