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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
184
in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
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
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
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
Time frame: 1-month period
the NRS score after treatment
Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain.
Time frame: at 1 week, 2 weeks, 2 months, 3 months after treatment
the 12-item Short-Form Health Survey (SF-12) score
Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status)
Time frame: 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).
Time frame: 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
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Analgesics consumption
the type of analgesics and analgesics consumption
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
Safety assessments
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intraoperative complications, PRF-related complications, esketamine-related complications
Time frame: 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
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment