Chronic Low Back Pain
Conditions
Brief summary
Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.
Interventions
DRUGLidoderm®
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Were currently experiencing moderate/severe pain despite current analgesic treatment 2. Had daily moderate-to-severe LBP for at least 3 months duration 3. Had a mean daily pain intensity score of \>6 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) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week
Exclusion criteria
1. Had a history of greater than one back surgery, or one back surgery within 3 months of study entry 2. Had severe spinal stenosis 3. Had chronic back pain of \>12 months duration with an undefined spinal diagnosis 4. Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.) 5. Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry 6. Had received trigger point injections within 2 weeks prior to study entry 7. Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry 8. Were taking a lidocaine-containing product that could not be discontinued while receiving study medication 9. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) 10. Had received Lidoderm for LBP in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint) | Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) |
Secondary
| Measure | Time frame |
|---|---|
| Pain relief (BPI Question 8) | — |
| Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS) | — |
| Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5) | — |
| QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS) | — |
| Safety assessments included AEs, discontinuations as a result of AEs, clinical laboratory tests, vital signs, physical examination, plasma lidocaine levels, dermal assessments and sking sensory testing | — |
| Patient and Investigator Global Impression of Pain Relief at Week 6 | — |
Countries
United States
Outcome results
None listed