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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Back Pain Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine5% v Lidocaine3.6%,Menthol1.25%

Daily patch Q12 followed by Q12 of no patch

Group Type ACTIVE_COMPARATOR

lidocaine 5% patch

Intervention Type DRUG

10cmx 14 cm transdermal patch sealed in its own pouch

lidocaine 3.6%, menthol 1.25%

Intervention Type DRUG

10cmx 14 cm transdermal patch sealed in its own pouch

Lidocaine 3.6%, menthol 1.25% v placebo

Daily patch Q12 followed by Q12 of no patch

Group Type PLACEBO_COMPARATOR

lidocaine 3.6%, menthol 1.25%

Intervention Type DRUG

10cmx 14 cm transdermal patch sealed in its own pouch

Placebo

Intervention Type DRUG

patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch

Interventions

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lidocaine 5% patch

10cmx 14 cm transdermal patch sealed in its own pouch

Intervention Type DRUG

lidocaine 3.6%, menthol 1.25%

10cmx 14 cm transdermal patch sealed in its own pouch

Intervention Type DRUG

Placebo

patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch

Intervention Type DRUG

Other Intervention Names

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Lidoderm LidoPatch

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No