Topical Lidocaine Patch in Low Back Pain

NCT ID: NCT00904540

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31

Brief Summary

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.

Conditions

Acute and Chronic Non-radicular LBP

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lidoderm®

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

Group Type: EXPERIMENTAL

Lidoderm®

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Lidocaine patch 5%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Endo Pharmaceuticals, Inc.

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Phoenix, Arizona, United States

Mill Valley, California, United States

Weston, Florida, United States

Bethpage, New York, United States

Charlotte, North Carolina, United States

Allentown, Pennsylvania, United States

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

EN3220-006

Identifier Type: -

Identifier Source: org_study_id