Effect of Ibuprofen Nanoemulsion Gel on Knee Osteoporosis pai

Phase 3

Recruiting

Conditions: Knee osteoarthritis.
Osteoarthritis of knee

Registration Number: IRCT20150902023864N3

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 124

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.