Post-Herpetic NeuralgiaNCT00305357
Evolution of Pain From Herpes Zoster
An observational study of Post-Herpetic Neuralgia and Acute Herpes Zoster, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Post-Herpetic Neuralgia, Acute Herpes Zoster
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females aged 50 or older with outbreak of herpes zoster occurring less than 6 weeks prior to study entry.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Pain and Neural Dysfunction From Acute Herpes Zoster to Post-Herpetic Neuralgia
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.
Read the 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.
- Conditions
- Post-Herpetic Neuralgia, Acute Herpes Zoster
- Keywords
- Post-Herpetic Neuralgia, Acute Herpes Zoster
- Medical subject headings
- Neuralgia, Postherpetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startNov 2001
- Primary completionNov 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Herpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Karin Petersen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305357
- Sponsor's protocol ID
- H5612-16138
- Status last verified
- Mar 2011
- First submitted
- 17 Mar 2006
- Last updated
- 24 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Pain and Neural Dysfunction From Acute Herpes Zoster to Post-Herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00305357
- Acronym / sponsor ID
- H5612-16138
- Conditions
- Post-Herpetic Neuralgia, Acute Herpes Zoster
- Keywords
- Post-Herpetic Neuralgia, Acute Herpes Zoster
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Nov 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females aged 50 or older with outbreak of herpes zoster occurring less than 6 weeks prior to study entry.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Petersen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Herpetic Neuralgia and Acute Herpes Zoster, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.