Topical Lidocaine Patch in Low Back Pain

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Acute and Chronic Non-radicular LBP

Treatments: Drug: Lidoderm®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904540

EN3220-006

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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131 participants in 1 patient group

Lidoderm®

Experimental group

Description:

Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain

Treatment:

Drug: Lidoderm®