Back Pain, Arthritis
Conditions
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.
Interventions
10cmx 14 cm transdermal patch sealed in its own pouch
DRUGlidocaine 3.6%, menthol 1.25%
10cmx 14 cm transdermal patch sealed in its own pouch
DRUGPlacebo
patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch
Sponsors
J.A.R. Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactJames J Ciullo, MBA
Backup ContactEric Castro, MD
Outcome results
None listed