Completed

NCT Number: NCT00904540

Topical Lidocaine Patch in 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.

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Key information

Conditions

Acute and Chronic Non-radicular LBP

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidoderm®

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)

Other names: Lidocaine patch 5%

Primary outcomes

Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2

Time frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42)

Secondary outcomes

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)
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)
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)
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)

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2002
First posted: May 19, 2009
Registry last updated: Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.