Efficacy and Safety of Synera in Osteoarthritis Pain

Study Overview
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Brief Summary
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Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Synera in OA Pain

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Synera
* Drug: Inactive patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synera<br>lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper. | Drug: Synera<br>* 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours<br>* Other names: lidocaine/tetracaine;|
| Placebo Comparator: Inactive Patch<br>placebo patch identical in appearance and composition (namely, the heating components) to the active patch other than lacking the lidocaine and tetracaine active ingredients. | Drug: Inactive patch<br>* placebo patch applied once for 12 hours<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index Knee Pain Scores on a Numeric Rating Scale (NRS) | Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible. | 5 minutes after stopped exercise, performed 1 hour after intervention (patch application) |