Topical Lidocaine Patch in Low Back Pain
- Registration Number
- NCT00904540
- Lead Sponsor
- Endo Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lidoderm® Lidoderm® Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)