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Topical Lidocaine Patch in Low Back Pain

Primary Purpose

Acute and Chronic Non-radicular LBP

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lidoderm®

About this trial

This is an interventional treatment trial for Acute and Chronic Non-radicular LBP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lidoderm®

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI)

Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores

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

Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments.

Full Information

NCT ID

NCT00904540

First Posted

May 15, 2009

Last Updated

February 8, 2010

Sponsor

Endo Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00904540

Brief Title

Topical Lidocaine Patch in Low Back Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

October 2002 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Endo Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute and Chronic Non-radicular LBP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidoderm®

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lidoderm®

Other Intervention Name(s)

Lidocaine patch 5%

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Time Frame