Recruiting

Pain Assessment Kit

Sponsor:

Analgesic Solutions

Code:

NCT01166295

Conditions

Neuralgia

Herpes Zoster

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01166295

Start date

Jul, 2010

Status verified date

Aug, 2010

Completion date

Nov, 2010

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Nathaniel Katz, MD, MS

781.444.9605nkatz@analgesicsolutions.com

Eric Osgood, MD

781.444.9605eosgood@analgesicsolutions.com

Locations

Analgesic Solutions

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

Eric Osgood, MD

781-444-9605eosgood@analgesicsolutions.com

Principal Investigator:

Nathaniel Katz, MD,MS

More Information

Sponsor

Analgesic Solutions

Last update posted

Aug 5, 2010

Last verified

Aug, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Analgesic Solutions on 2010-08-05.