Efficacy and Safety of Synera in Osteoarthritis Pain

Subjects participated in two visits each at least 1 week apart, where they underwent two exercise interventions - a baseline exercise without treatment and a experimental exercise with intervention (Synera patch or Inactive patch). Participants rated their pain on a NRS-11 1 minute, 5 minutes, and 60 minutes after both exercises, as well as 6 hours after the experimental exercise, before bedtime, and the following morning. Subjects were randomized to receive either Synera at the first visit and the inactive patch at the second visit or the inactive patch at the first visit and Synera patch at the second visit.

Inclusion criteria

• Men and women, age 40 years and above
• Meet American College of Rheumatology criteria for knee OA
• Knee pain most days of the week for the past month
• Knee pain > 5/10 after exercise intervention
• Capable of undertaking exercise intervention
• Stable cardiovascular function
• Able to return for all clinic visits
• Able to read and understand the informed consent document

Exclusion criteria

• Use of a walker to ambulate or inability to ambulate
• Other forms of arthritis
• Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
• History of myocardial infarction
• Blood Pressure > 140 systolic/100 diastolic
• Scheduled for and likely to need joint replacement surgery in the next 3 months
• Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
• Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.