Efficacy and Safety of Synera in Osteoarthritis Pain

Phase 1

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Inactive patch; Drug: Synera

• Registration Number: NCT01654302
• Lead Sponsor: Thomas J. Schnitzer

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Study Start: 2013-09
• Primary Completion: 2014-09
• Results First Submitted: 2014-09-29
• Results First Submitted QC: 2014-11-03
• Results First Posted: 2014-11-10
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

1. Use of a walker to ambulate or inability to ambulate
2. Other forms of arthritis
3. 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
4. History of myocardial infarction
5. Blood Pressure > 140 systolic/100 diastolic
6. Scheduled for and likely to need joint replacement surgery in the next 3 months
7. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
8. Sensitivity to lidocaine, topical or injectable analgesics/anesthetics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inactive Patch	Inactive patch	placebo patch identical in appearance and composition (namely, the heating components) to the active patch other than lacking the lidocaine and tetracaine active ingredients.
Synera	Synera	lidocaine/tetracaine patch with heating component which consists of iron powder, activated carbon, sodium chloride, wood flour, water and filter paper.

Primary Outcome Measures

Name	Time	Method
Index Knee Pain Scores on a Numeric Rating Scale (NRS)	5 minutes after stopped exercise, performed 1 hour after intervention (patch application)	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States