Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT00305357
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00305357
Study Brief:
Protocol Section:
NCT00305357