Topical Lidocaine Patch in Low Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Acute and Chronic Non-radicular LBP
• Intervention / Treatment: Drug: Lidoderm®

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • Mill Valley, California, United States
  • Florida
    • Weston, Florida, United States
  • New York
    • Bethpage, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States
  • Wisconsin
    • Madison, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Drug: Lidoderm®; 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); Other Names: Lidocaine patch 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Investigators: Study Director: Study Director, Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): October 1, 2002

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimated): May 19, 2009

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: EN3220-006