Lidoderm(r) and Low Back Pain
Low back pain is a complex and difficult to treat condition that is associated with significantly decreased quality of life and may require several different treatments for optimal pain relief. It is estimated that more than 17 percent of the work force is affected by low back pain with direct and indirect costs exceeding $50 billion per year. The six-week, open-label, parallel-group pilot study that was presentedevaluated the effectiveness of Lidoderm(R) on distinct and common painqualities present in low back pain using the Neuropathic Pain Scale (NPS), a validated assessment tool that measures distinct components of pain.
Lidoderm (lidocaine patch 5%) is made of an adhesive material containing 5% lidocaine, which is attached to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed before application to the skin. The size of the patch is 10 cm × 14 cm.
Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: methylparaben, polyacrylic acid, polyvinyl alcohol, propylene glycol, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, and urea.
Lidoderm Indication And Usage
Lidoderm is used for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
Early studies suggest that it may provide considerable relief for people who suffer from low back pain. Even with continuous use of four patches a day very few adverse effects are seen. If further studies support its benefits, the patch could prove to be an important treatment.
"The topical analgesic Lidoderm(R) is an innovative treatment for post-herpetic neuralgia that is effective and well-tolerated. I am encouraged by these new studies that suggest Lidoderm(R) may also offer pain relief for patients who suffer from low back pain and osteoarthritis, and look forward to evaluating Lidoderm(R) in placebo-controlled studies for these indications."
When Lidoderm is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. At least 95% (665 mg) of lidocaine will remain in a used patch. Mean peak blood concentration of lidocaine is about 0.13 µg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias). Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily usage.
Single-dose treatment with Lidoderm was compared to treatment with a patch without lidocaine, and to no treatment (observation only) in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients. Pain intensity and pain relief scores were evaluated periodically for 12 hours. Lidoderm performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours.
Contraindications
Lidoderm is contraindicated in people with a known history of sensitivity to the amide type local anesthetics or to any other component of the product.
The most commonly reported treatment-related adverse events were skin-related, such as rash, and were categorized as mild-to-moderate."There is a critical need to develop effective and well-tolerated newapproaches to treating chronic low back pain in this enormous patientpopulation," said Dr. Gimbel. "Promising data from this study suggestLidoderm(R), used as either monotherapy or adjunctive therapy, may alleviate acute and chronic low back pain, but additional placebo-controlled studies are needed to confirm this observation."
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