This study compared the efficacy of topical lidocaine patches versus vehicle (placebo) patches applied directly to the painful skin of subjects with postherpetic neuralgia (PHN) utilizing an 'enriched enrollment' study design. All subjects had been successfully treated with topical lidocaine patches on a regular basis for at least 1 month prior to study enrollment. Subjects were enrolled in a randomized, two-treatment period, vehicle-controlled, cross-over study. The primary efficacy variable was 'time to exit'; subjects were allowed to exit either treatment period if their pain relief score decreased by 2 or more categories on a 6-item Pain Relief Scale for any 2 consecutive days. The median time to exit with the lidocaine patch phase was greater than 14 days, whereas the vehicle patch exit time was 3.8 days (P < 0.001). At study completion, 25/32 (78.1%) of subjects preferred the lidocaine patch treatment phase as compared with 3/32 (9.4%) the placebo patch phase (P < 0.001). No statistical difference was noted between the active and placebo treatments with regards to side effects. Thus, topical lidocaine patch provides significantly more pain relief for PHN than does a vehicle patch. Topical lidocaine patch is a novel therapy for PHN that is effective, does not cause systemic side effects, and is simple to use.
Few data have been published regarding the natural history, course of symptoms, and quality of life in Complex Regional Pain Syndrome (CRPS). To obtain preliminary data regarding these important issues in CRPS, a set of patient self-report questionnaires were mailed to patients with the diagnosis of CRPS who had been assessed and/or treated at a tertiary university-based pain center in the United States. Self-reports of demographic information, symptoms, the Neuropathic Pain Scale, and a modified Brief Pain Inventory (mBPI) were received from 31 CRPS patients. Approximately 75% of patients reported initial symptoms of pain, swelling, coldness, and color changes. An additional 71% had weakness and inability to move the extremity as initial symptoms. Weakness at some time during their course of CRPS was described by 97%. A majority reported no overall improvement or worsening of symptoms over time (mean 3.3 years). The pain descriptors with the highest mean values were "deep" (6.4/10), "unpleasant" (6.4), "sensitive" (5.7), "surface" (5.4), and "dull" (5.3) pains. Significant sleep disturbance was reported by 80%. CRPS had a severe impact on quality of life, with substantial interference reported in 9 of 10 mBPI activity items by a majority of these patients. These findings should be viewed with caution and should not be generalized to the entire CRPS population because the cohort was small and select. A large multicenter prospective study needs to be performed to validate these preliminary findings.
Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects. Topically applied drugs have the potential to act locally in the soft tissues without systemic effects. This study assessed the efficacy and safety of topical diclofenac (NSAID) patch applied directly to the painful injury site for the treatment of acute minor sports injury pain. Adult subjects (N = 222) were recruited from two communities for a multicenter, randomized, placebo-controlled, parallel design study. All subjects had suffered a painful minor sports injury within the prior 72 hours of study entry. Either a diclofenac epolamine or placebo topical patch was applied directly to the skin overlying the painful injured site twice daily for 2 weeks. Measures of pain intensity were performed in a daily diary and at clinic visits on days 3, 7, and 14. Diclofenac patch was superior to placebo patch in relieving pain. Statistical significance was seen on clinic days 3 (P = 0.036) and 14 (P = 0. 048), as well as the daily diary pain ratings at days 3, 7, and 14 (P < or =0.044). No statistically significant differences were seen in any safety or side-effect measures with the diclofenac patch as compared to the placebo patch. Diclofenac epolamine patch is an effective and safe pain reliever for treatment of minor sports injury pain. The advantages of this novel therapy include its ease of use and lack of systemic side effects.
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