Knee osteoarthritis. Osteoarthritis of knee
Conditions
Interventions
Intervention 1: Intervention group 1: Nanoemulsion gel containing 5% ibuprofen
Patients are treated with this formulation for 4 weeks and three times a day in the size of a fingertip (equivalent to 100 mg), which has already been prepared and animal studies have been performed.
Patients are treated with a commercial gel available in the pharmacy in the size of a fingertip three times a day, for 4 weeks.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Unilateral or bilateral knee osteoarthritis with radiographic evidence according to American College of Rheumatology criteria and the International Osteoarthritis Research Society which is diagnosed through physical examination by the physician Having mild to moderate knee osteoarthritis pain Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Very severe knee pain Recent lower limb injury or surgery such as repair and joint replacement Inflammatory arthritis Metabolic bone disease Fracture and/or dislocation of knee History of an open wound in the affected knee History of adverse reactions to NSAIDs Diabetes and Lupus disease Corticosteroid injection into the knee within 30 days of intervention Multiple sclerosis (MS) The dermatologic disorder which affected the surrounding skin of the knees Uncontrolled heart failure High blood pressure Chronic renal failure Respiratory diseases Cancer History of alcohol or drug abuse History of neurological disorders affecting sensory, motor or cognitive function
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Skin irritation. Timepoint: 24-48 hours in initial use, then two-and four-week visits. Method of measurement: Questions are asked by phone during the first 24-48 hours, so any skin problems are requested and checked by the doctor during each visit. | — |
Primary
| Measure | Time frame |
|---|---|
| Pain score based on visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Timepoint: Patients are assessed prior to enrollment and, then, 2 and 4 weeks subsequent to the intervention for knee pain. Method of measurement: Visual analogue scale on a 10 cm scale and Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFariba Esmaeili
Tehran University of Medical Sciences
Outcome results
None listed