Comparing the effect of Topical 1% Hedera helix L. Extract gel and 1% Diclofenac gel in the Treatment of Primary Knee Osteoarthritis Patients

The aim of this study is to compare the effect of the topical use of 1% Hedera helix L. extract gel and 1%diclofenac gel on knee osteoarthritis.

Two arm parallel group randomised trial with blinded postoperative care and outcome assessment

The study population consisted of 150 patients referring to Imam Ali Clinic affiliated with Shahrekord University of Medical Sciences and private offices across Shahrekord diagnosed with knee osteoarthritis who were selected by convenience sampling.

Inclusion criteria were primary osteoarthritis in at least one knee with orthopedic diagnosis based on radiological criteria in knee image, having pain at least 2 weeks before treatment, and having age above 45 years. People who had secondary osteoarthritis, active liver or kidney disease, peptic ulcer, diabetes, thyroid and parathyroid diseases, and coagulation disorders, consumed anticoagulant drugs, history of ischemic or hemorrhagic stroke or deep vein thrombosis, allergy to any anti-inflammatory drug, alcohol abuse, drug abuse, orally used other analgesics and other effective compounds for the treatment of osteoarthritis up to 10 days before beginning of the study, and had pregnancy, history of local fractures, and deformities leading to osteoarthritis and articular diseases were not enrolled in the study.

Patients were divided into three groups of 50 each by convenience random allocation, and each group used only one of the tubes of 60 g of diclofenac 1% gel, H. helix extract 1% gel, and placebo. Demographic data were collected and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a standard instrument to measure pain, namely, visual analogue scale (VAS) were administered.

Knee pain; Morning stiffness; Daytime stiffness; Physical function

Patients will be divided into three groups by simple random sampling and Using three categories of cards that listed on them the letters A, B and C

In this study considering the use of similar tubes in all three groups participants and their carers, as well as the assessor, are not aware of the contents of the tubes.