Development of a Bedside Pain Assessment Kit for Postherpetic Neuralgia

NCT01166295 | Unknown

• 1 other identifier: MRK.008a.2010
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuralgia; Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Demonstrate usability of the BSTK.

  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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Analgesic Solutions: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Analgesic Solutions

Natick, Massachusetts, 01760, United States

RECRUITING

MeSH Terms

Conditions

Neuralgia; Herpes Zoster

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Nathaniel Katz, MD, MS

  Analgesic Solutions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathaniel Katz, MD, MS

CONTACT

781.444.9605; nkatz@analgesicsolutions.com

Eric Osgood, MD

CONTACT

781.444.9605; eosgood@analgesicsolutions.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 21, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 5, 2010

Record last verified: 2010-08

Locations

US (1)