Clinical Trial Issues

Traditionally, the assessment of novel analgesics has been based on methods and models based on the clinical utility of opioid analgesics.14 Many of the endpoints measured involve the use of self-report methodologies including the classical visual analog scale (VAS) with which patients rate their pain from a score of 0 (no noticeable pain) to 10 (worst pain imaginable). For the specific assessment of neuropathic pain, clinical studies have used tools like the McGill Pain Questionnaire, Neuropathic Pain Scale, and the Neuropathic Pain Symptoms Inventory. While the use of many of these analgesic endpoints has been validated in the clinical setting, the use of specific combinations of these scales may be useful to enhance the sensitivity of clinical outcomes for new analgesic compounds.

Clinical trial designs often employ parallel placebo-controlled and randomized withdrawal types of experimental manipulations.14'35 The majority of these designs have been well validated using opioids; however, the relative utility in assessing novel analgesics that target specific aspects of chronic pain (e.g., neuropathic allodynia) await further evaluation (e.g., non-NSAID (nonsteroidal anti-inflammatory drug) mediated analgesia in the third molar extraction model).

A number of nociceptive tests have also been used in experimental clinical trials including acute heat sensitivity, topical and intradermal capsaicin, heat/capsaicin combinations, and quantitative sensory testing using both mechanical and thermal stimuli.36,37 Some of these tests can also be coupled to other functional readouts such as functional MRI

Peripheral Neuropathy Natural Treatment Options

Peripheral Neuropathy Natural Treatment Options

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