Topical Lidocaine Patch in Low Back Pain

• Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI) [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
• Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
• 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 [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
• Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments. [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: Yes ]

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.

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