Herpes Zoster
Conditions
Keywords
Herpes Zoster Neuralgia, Esketamine
Brief summary
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.
Detailed description
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.
Interventions
DRUGesketamine group
in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
DRUGPRF group
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
Sponsors
Beijing Xiaotangshan Hospital
The First Hospital of Fangshan District,Beijing
Beijing Ditan Hospital
Hengshui People's Hospital
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ages more than 18 years; 2. Patients with onset of herpes zoster (HZ) rash less than 90 days; 3. HZ affected the spinal nerves (cervical/thoracic/lumbar nerve); 4. Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)； 5. Planned to perform CT-guided PRF treatment of the dorsal root ganglion(DRG).
Exclusion criteria
1. Obstructive sleep apnoea syndrome; 2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG. 3. A history of systemic immune diseases, organ transplantation, or cancers; 4. A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder; 5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium; 6. Comorbid hyperthyroidism or phaeochromocytoma; 7. Recent history of drug abuse; 8. Having contraindications to esketamine; 9. Communication difficulties. 10. Women who are preparing for pregnancy, in the pregnancy or lactation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the NRS score at 1 month after treatment. | 1-month period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the 12-item Short-Form Health Survey (SF-12) score | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status) |
| the Pittsburgh Sleep Quality Index (PSQI) score | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality). |
| The Patient Global Impression of Change scale (PGIC) | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | The proportion of patients with a response of no change, minimally improved, much improved or very much improved on PGIC |
| the NRS score after treatment | at 1 week, 2 weeks, 2 months, 3 months after treatment | Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain. |
| Safety assessments | at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months | intraoperative complications, PRF-related complications, esketamine-related complications |
| success rate | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | The success rate is defined as more than a 50% reduction in NRS-11 score |
| Analgesics consumption | at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | the type of analgesics and analgesics consumption |
Countries
China
Contacts
Primary ContactFang Luo
Outcome results
None listed