Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis

Study Overview
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Brief Summary
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A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.

Detailed Description
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In this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. Subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. After randomization subjects completed a baseline questionnaire regarding how pain affects their lives. Then they began therapy with their blinded product. This same questionnaire was administered after the second day of therapy and after the final day on day 10. Responses at the day two and ten endpoints were compared to baseline to access the response of each arm.

Official Title
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Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis

Conditions
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Back Pain, Arthritis

Intervention / Treatment
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* Drug: lidocaine 5% patch
* Drug: lidocaine 3.6%, menthol 1.25%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of back pain Diagnosis of arthritis Exclusion Criteria: Pregnancy or expected pregnancy in the next three months Allergic to any lidocaine, menthol and methylparaben No reliable access to the internet Baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to 10. Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine5% v Lidocaine3.6%,Menthol1.25%<br>Daily patch Q12 followed by Q12 of no patch | Drug: lidocaine 5% patch<br>* 10cmx 14 cm transdermal patch sealed in its own pouch<br>* Other names: Lidoderm;Drug: lidocaine 3.6%, menthol 1.25%<br>* 10cmx 14 cm transdermal patch sealed in its own pouch<br>* Other names: LidoPatch;|
| Placebo Comparator: Lidocaine 3.6%, menthol 1.25% v placebo<br>Daily patch Q12 followed by Q12 of no patch | Drug: lidocaine 3.6%, menthol 1.25%<br>* 10cmx 14 cm transdermal patch sealed in its own pouch<br>* Other names: LidoPatch;Drug: Placebo<br>* patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten | Day ten | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. | Day ten | 
| Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. | Day 10 | 
| Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. | Day 10 | 
| Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. | Day 10 |