Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

Study Overview
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Brief Summary
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Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.

Official Title
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A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Lidoderm®
* Drug: Lidoderm®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Were currently experiencing moderate/severe pain despite current analgesic treatment Had daily moderate-to-severe LBP for at least 3 months duration Had a mean daily pain intensity score of >6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week Exclusion Criteria: Had a history of greater than one back surgery, or one back surgery within 3 months of study entry Had severe spinal stenosis Had chronic back pain of >12 months duration with an undefined spinal diagnosis Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.) Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry Had received trigger point injections within 2 weeks prior to study entry Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry Were taking a lidocaine-containing product that could not be discontinued while receiving study medication Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) Had received Lidoderm for LBP in the past

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1- Lidoderm®<br>Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain | Drug: Lidoderm®<br>* Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.<br>* Other names: Lidocaine patch 5%;|
| Placebo Comparator: 2-Placebo<br>Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain | Drug: Lidoderm®<br>* Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.<br>* Other names: Lidocaine patch 5%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint) |  | Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5) |  |  | 
| Pain relief (BPI Question 8) |  |  | 
| Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS) |  |  | 
| Patient and Investigator Global Impression of Pain Relief at Week 6 |  |  | 
| QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS) |  |  | 
| Safety assessments included AEs, discontinuations as a result of AEs, clinical laboratory tests, vital signs, physical examination, plasma lidocaine levels, dermal assessments and sking sensory testing |  |  |