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| Name | Class |
|---|---|
| Beijing Xiaotangshan Hospital | OTHER |
| The First Hospital of Fangshan District,Beijing | OTHER |
| Beijing Ditan Hospital | OTHER |
| Hengshui People's Hospital |
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To assess the 1-month effects and safety of esketamine - PRF -standardized drug treatment against PRF -standardized drug treatment acute/subacute zoster-associated pain (ZAP) patients.
This study aims to determine whether the addition of esketamine to PRF - standardized drug treatment can improve 1 - month pain control and safety profiles in acute/subacute ZAP patients. The findings may help optimize current treatment strategies for refractory ZAP patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine group | Experimental | Esketamine+ PRF group |
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| control group | Active Comparator | PRF group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esketamine group | Drug | in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine. |
| Measure | Description | Time Frame |
|---|---|---|
| the NRS score at 1 month after treatment. | The Numeric Rating Scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain | 1-month period |
| Measure | Description | Time Frame |
|---|---|---|
| the NRS score after treatment | Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain. | at 1 week, 2 weeks, 2 months, 3 months after treatment |
| the 12-item Short-Form Health Survey (SF-12) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +86 13611326978 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| OTHER |
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| PRF group | Drug | In the control group, patients will receive PRF+standardized drug treatment. Pulsed radiofrequency (PRF) will be performed on DRG by an designated physician in each participating center. They will be treated with PRF (PMG-230, Baylis Medical Inc.) using a 21-gauge sterilized radiofrequency needle (a 10-cm trocar with a 5-mm active tip, PMF-21-100-5, Baylis Medical Inc.), which are carefully inserted until the needle tip reaches the upper edge of the intervertebral foramen. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. The standardized drug treatment will include antiviral therapy, anticonvulsant treatment, three-step analgesic therapy |
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Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status) |
| at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| the Pittsburgh Sleep Quality Index (PSQI) score | Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality). | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| The Patient Global Impression of Change scale (PGIC) | The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| Analgesics consumption | the type of analgesics and analgesics consumption | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| Safety assessments | intraoperative complications, PRF-related complications, esketamine-related complications | at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months |
| success rate | The success rate is defined as more than a 50% reduction in NRS-11 score | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment |
| D007239 | Infections |