Acute and Chronic Non-radicular LBP
Conditions
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.
Interventions
DRUGLidoderm®
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)
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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) |
Countries
United States
Outcome results
None listed