Evolution of Pain From Herpes Zoster

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305357
First received: March 17, 2006
Last updated: April 12, 2011
Last verified: March 2011
  Purpose

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.


Condition
Post-Herpetic Neuralgia
Acute Herpes Zoster

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of Pain and Neural Dysfunction From Acute Herpes Zoster to Post-Herpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 100
Study Start Date: November 2001
Study Completion Date: December 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Pain, nerve trunk inflammation, and neuronal injury are hallmarks of acute herpes zoster (AHZ). We hypothesize that the development of post-herpetic neuralgia (PHN) strongly depends on two factors: 1) the severity of the initial neural injury and 2) the ability to recover from the initial neural injury. To test this hypothesis, we will prospectively follow 150 patients at high risk for development of PHN. Evolution of pain and neural injury will be evaluated at 2-6 weeks, 6 weeks, 3 months, 6 months and 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.

Preliminary analysis of study data showed reduced innervation in HZ skin, mirror image skin and distant control skin in the acute phase of HZ that was not specific to the persistence of pain at 3 months. The innervation appeared to recover more fully by 6 months in distant control skin than in mirror-image skin and HZ skin, despite the fact that the subjects were continuing to experience a further reduction in their zoster-associated pain. This suggests that the symptoms of pain and sensory dysfunction are not due to a mere loss in overall innervation density. The proposed subsequent ≥ 2 year study visit and analysis will allow us to directly correlate pain resolution with resolution of sensory and innervation abnormalities.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  1. Males and females aged 50 or older and in stable general health.
  2. Able and willing to provide written informed consent.
  3. Able to understand and follow the instructions of the investigator, including the pain intensity rating scales.
  4. 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.
  5. The outbreak of herpes zoster must have occurred less than 6 weeks prior to study entry.
  6. 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.

Exclusion Criteria:

  1. The AHZ outbreak is complicated by stroke or myelopathy.
  2. Patients with facial or cranial AHZ.
  3. Patients with signs of spinal cord or brainstem injury from HZ.
  4. Patients who are considered unreliable as to study compliance or adherence to scheduled appointments as determined by the Investigators.
  5. 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.
  6. Bleeding disorders.
  7. Patients with known skin pathology.
  8. Use of topical steroids, capsaicin, local anesthetics or topical aspirin/NSAID preparations within two weeks of the study sessions.
  9. Another pain problem of equal or greater severity than AHZ.
  10. Allergy or idiosyncratic reaction to lidocaine or capsaicin.
  11. Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of pain and sensory systems.
  12. Has received neuroablative nerve blocks or neurosurgical procedures for AHZ pain prior to entering the study.
  13. Patients who are unable to read or speak English.
  14. Those, in the opinion of the investigator, who are unlikely to comply with the study protocol or who are unsuitable for any other reason.
  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: NCT00305357

Locations
United States, California
UCSF
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Karin Petersen, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Karin Petersen, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00305357     History of Changes
Other Study ID Numbers: H5612-16138
Study First Received: March 17, 2006
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Post-Herpetic Neuralgia
Acute Herpes Zoster

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 July 24, 2014