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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Analgesic Solutions.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Analgesic Solutions
ClinicalTrials.gov Identifier:
NCT01166295
First received: July 12, 2010
Last updated: August 3, 2010
Last verified: August 2010
  Purpose

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.


Condition
Neuralgia
Herpes Zoster

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Bedside Pain Assessment Kit for Postherpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by Analgesic Solutions:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 12
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)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166295

Contacts
Contact: Nathaniel Katz, MD, MS 781.444.9605 ext 124 nkatz@analgesicsolutions.com
Contact: Eric Osgood, MD 781.444.9605 ext 128 eosgood@analgesicsolutions.com

Locations
United States, Massachusetts
Analgesic Solutions Recruiting
Natick, Massachusetts, United States, 01760
Contact: Eric Osgood, MD    781-444-9605 ext 128    eosgood@analgesicsolutions.com   
Principal Investigator: Nathaniel Katz, MD,MS         
Sub-Investigator: Eric Osgood, MD         
Sponsors and Collaborators
Analgesic Solutions
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Nathaniel Katz, MD, MS Analgesic Solutions
  More Information

No publications provided

Responsible Party: Nathaniel Katz, MD,MS - Principal Investigator, Analgesic Solutions
ClinicalTrials.gov Identifier: NCT01166295     History of Changes
Other Study ID Numbers: MRK.008a.2010
Study First Received: July 12, 2010
Last Updated: August 3, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014