Development of a Bedside Pain Assessment Kit for Postherpetic Neuralgia (BSTK)
Recruitment status was: Recruiting
Post herpetic neuralgia (PHN) is an undertreated condition. It is a type of neuropathic pain (NP), or pain caused by abnormal activity of sensory nerves. Its mechanisms are not fully understood, and medication trials for PHN pain and other types of NP are frequently unsuccessful.
There has been extensive investigation aimed at identifying and understanding the specific mechanisms of NP. While some of these tests are inexpensive and easy to perform at the bedside, many require expensive tools and highly equipped laboratory facilities. Further, there is no standard method for assessment of pain in NP patients.
The investigators aim to test a Bedside Sensory Testing Kit (assessment for Neuropathic Pain) on a small number of patients with PHN.
The purpose of the Kit is to identify mechanisms of pain. The goal of this research is to design a way to classify patients with PHN based on what mechanisms are causing their pain, since this may help predict the best medications for individual patients.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Development of a Bedside Pain Assessment Kit for Postherpetic Neuralgia|
- Demonstrate usability of the BSTK. [ Time Frame: Subject Duration in the study is one (1) clinic visit ( approximatley 2-3 hours). We expect 10 weeks of open enrollment. Total study timeline is 4 months(1 month start up, 2 months enrollment, 1 month clean and analysis, 2 weeks final CSR. ] [ Designated as safety issue: No ]
Analysis of subject feedback regarding clarity of instructions, burden of study procedures, and overall experience.
Analysis of investigator observations regarding clinical feasibility, investigator burden, and overall experience.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
We hypothesize: (a) that a Bedside Sensory Testing Kit for PHN can be designed such that it works efficiently with Subjects and Investigators, is tolerated well by Subjects, and is statistically reliable between Investigators; (b) that the sensory testing kit can distinguish between PHN patients with different sensory qualities to their pain which may be caused by different underlying pain mechanisms.
The subjects will be patients with postherpetic neuralgia who voluntarily participate and meet eligibility criteria. The study participants will complete a brief questionnaire and undergo three rounds of the BSTK, performed by two study investigators. The items in the BSTK correspond to a series of sensory assessments, each of which are aimed to contribute to the characterization of individuals' PHN pain.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166295
|United States, Massachusetts|
|Natick, Massachusetts, United States, 01760|
|Principal Investigator:||Nathaniel Katz, MD, MS||Analgesic Solutions|