Evolution of Pain From Herpes Zoster

NCT00305357 | Completed

• 1 other identifier: H5612-16138
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Evolution of pain and neural injury will be evaluated at 2 years or longer after the onset of AHZ by multiple measures. Assessments at 2 years or longer will be compared to those collected during the first 6 months after HZ in order to test whether or not sensory function and cutaneous innervation continues to normalize beyond 6 months in subjects who recover from HZ without severe PHN.

Conditions

Post-Herpetic Neuralgia; Acute Herpes Zoster

Keywords

Post-Herpetic Neuralgia; Acute Herpes Zoster

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females aged 50 or older with outbreak of herpes zoster occurring less than 6 weeks prior to study entry.

You may qualify if:

• Males and females aged 50 or older and in stable general health.
• Able and willing to provide written informed consent.
• Able to understand and follow the instructions of the investigator, including the pain intensity rating scales.
• Subjects must have an acute outbreak of cervical, thoracic or lumbosacral HZ with unilateral skin rash and pain; the diagnosis will be based on physical examination and review of available medical records confirming the outbreak.
• The outbreak of herpes zoster must have occurred less than 6 weeks prior to study entry.
• PHN pain must be of at least moderate severity, defined as self-report of average pain level of 20 mm on a 100 mm visual analog scale.

You may not qualify if:

• The AHZ outbreak is complicated by stroke or myelopathy.
• Patients with facial or cranial AHZ.
• Patients with signs of spinal cord or brainstem injury from HZ.
• Patients who are considered unreliable as to study compliance or adherence to scheduled appointments as determined by the Investigators.
• Patients, who are undergoing active treatment for cancer, are infected with the Human Immunodeficiency Virus, or are being acutely and intensively immunosuppressed following a transplantation procedure.
• Bleeding disorders.
• Patients with known skin pathology.
• Use of topical steroids, capsaicin, local anesthetics or topical aspirin/NSAID preparations within two weeks of the study sessions.
• Another pain problem of equal or greater severity than AHZ.
• Allergy or idiosyncratic reaction to lidocaine or capsaicin.
• Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of pain and sensory systems.
• Has received neuroablative nerve blocks or neurosurgical procedures for AHZ pain prior to entering the study.
• Patients who are unable to read or speak English.
• Those, in the opinion of the investigator, who are unlikely to comply with the study protocol or who are unsuitable for any other reason.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karin Petersen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 21, 2006
• Study Start: November 1, 2001
• Primary Completion: November 1, 2005
• Study Completion: December 1, 2006
• Last Updated: May 24, 2023

Record last verified: 2011-03

Locations

US (1)