Knee Osteoarthritis
Conditions
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.
Interventions
DRUGSynera
70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
DRUGInactive patch
placebo patch applied once for 12 hours
Sponsors
Nuvo Research Inc.
Thomas J. Schnitzer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Synera Then Placebo Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7). | 19 |
| Placebo Then Synera Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7). | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention (Day 7) | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Synera Then Placebo | Placebo Then Synera | Total |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 7.01 | 60 years STANDARD_DEVIATION 8.26 | 58 years STANDARD_DEVIATION 7.77 |
| Baseline Index Knee Pain Scores | 5.90 units on a scale STANDARD_DEVIATION 1.25 | 6.26 units on a scale STANDARD_DEVIATION 1.37 | 6.08 units on a scale STANDARD_DEVIATION 1.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 9 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 23 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 39 | 2 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
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.
Time frame: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application)
Population: Of the 40 subjects 2 were lost to follow-up, one from each group, making a total of 38 participants included in the analysis. Unfortunately, NRS data at 5 minutes post-exercise is missing for 2 subjects in the Synera treatment group and 1 subject in the Placebo group due to technical errors. The data was captured but we were unable to retrieve it.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synera | Index Knee Pain Scores on a Numeric Rating Scale (NRS) | 4.167 units on a scale | Standard Deviation 2.242 |
| Inactive Patch | Index Knee Pain Scores on a Numeric Rating Scale (NRS) | 4.703 units on a scale | Standard Deviation 2.253 |