Topical Lidocaine Patch in Low Back Pain (NCT00904540) | Clinical Trial Compass
CompletedPhase 4
Topical Lidocaine Patch in Low Back Pain
United States131 participantsStarted 2002-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2