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

Not Applicable

• Conditions: Back Pain; Arthritis
• Interventions: Drug: lidocaine 3.6%, menthol 1.25%; Drug: lidocaine 5% patch; Drug: Placebo

• Registration Number: NCT02749123
• Lead Sponsor: J.A.R. Laboratories

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-19
• Last Update Submitted: 2016-04-19
• Study First Posted: 2016-04-22
• Last Update Posted: 2016-04-22
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine 3.6%, menthol 1.25% v placebo	lidocaine 3.6%, menthol 1.25%	Daily patch Q12 followed by Q12 of no patch
Lidocaine5% v Lidocaine3.6%,Menthol1.25%	lidocaine 5% patch	Daily patch Q12 followed by Q12 of no patch
Lidocaine5% v Lidocaine3.6%,Menthol1.25%	lidocaine 3.6%, menthol 1.25%	Daily patch Q12 followed by Q12 of no patch
Lidocaine 3.6%, menthol 1.25% v placebo	Placebo	Daily patch Q12 followed by Q12 of no patch

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Day ten	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.
Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Day 10	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.
Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Day 10	Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.
Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale	Day 10	Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten.

Trial Locations

Locations (1)

Advocate Good Sheppard Hospital; 🇺🇸 Barrington, Illinois, United States