Development of a Bedside Pain Assessment Kit for Postherpetic Neuralgia (BSTK)

August 3, 2010 updated by: Analgesic Solutions

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 Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Natick, Massachusetts, United States, 01760
        • Recruiting
        • Analgesic Solutions
        • Contact:
        • Principal Investigator:
          • Nathaniel Katz, MD,MS
        • Sub-Investigator:
          • Eric Osgood, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample patients with postherpetic neuralgia who voluntarily participate and meet eligibility criteria

Description

Inclusion Criteria:

  • Subject is between 40 and 85 years old.
  • Physician documentation of history of postherpetic neuralgia must be provided; pain persisting more than 3 months/90 days after a patient's vesicular rash (shingles) has healed.
  • Subject is able to speak, read and write in English and comply with all study procedures;
  • Subject is willing to voluntarily sign and date an Informed Consent Form, approved by an IRB, prior to the conduct of any study-specific procedures;
  • Subject must be willing to abstain from PRN (as needed) pain medicine for 12 hours prior to the study but may continue their standing doses of pain medicine.

Exclusion Criteria:

  • Subject is pregnant and/or breast-feeding.
  • Subjects with additional sources of chronic pain will not be allowed if the severity of pain in additional locations is severe enough to compromise assessment of PHN pain. This will be left to the Investigator's discretion.
  • Subject has a medical condition, other than PHN, that is not well-controlled with treatment; or the subject has any clinically significant condition that would, in the opinion of the investigator, preclude study participation, interfere with the assessment of pain, or pose unacceptable risk to the participant.
  • Subject has been enrolled in another study within 30 days.
  • Subject has a known contact allergy to surgical skin markers.
  • In the judgment of the investigator, the subject has a psychiatric or psychological disorder that would interfere with the completion of the study, confound the study results, or pose patient risk.
  • Subject has neuropathy or nerve fiber disease other than PHN (e.g., diabetic peripheral neuropathy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Analgesic Solutions

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Nathaniel Katz, MD, MS, Analgesic Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (Estimate)

July 21, 2010

Study Record Updates

Last Update Posted (Estimate)

August 5, 2010

Last Update Submitted That Met QC Criteria

August 3, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRK.008a.2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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