Topical Lidocaine Patch in Low Back Pain

Study Overview
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Brief Summary
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Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.

Official Title
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Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain

Conditions
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Acute and Chronic Non-radicular LBP

Intervention / Treatment
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* Drug: Lidoderm®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-radicular LBP pain for ≤12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg) Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms Had an average daily pain intensity score of >4 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) within 24 hours prior to the screening visit. Had a normal neurological examination, including: Motor strength Sensory testing (light touch, pinprick, and vibration) Deep tendon reflexes Patients were eligible for participation in the long-term chronic (>12 months) group of the study if they also: Had LBP for greater than one year. Patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy 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 and radicular symptoms Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief 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 Botox Injections within 3 months prior to study entry Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) Patients were excluded from participation in the long-term chronic (>12 months) group if they also: Had an undefined spinal diagnosis Had a history of lumbar spine surgery within 6 months prior to study entry

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidoderm®<br>Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain | Drug: Lidoderm®<br>* Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (<6 weeks) LBP, subacute (6 weeks to <3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (>12 months LBP)<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 intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2 |  | Visits - 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 6 in average pain intensity (Question 5 of the BPI) |  | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | 
| Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores |  | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | 
| QOL: change from baseline to Week 2 to Week 6 in Question 9 of the BPI, in Beck Depression Inventory Questionnaire, and the Patient and Investigator Global Assessment of Patch Satisfaction and Pain Relief |  | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) | 
| Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments. |  | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) |