Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT06914206
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100070, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.
Other names: esketamine+PRF+ standardized drug treatment
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
Other names: PRF+standardized drug treatment
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment
the type of analgesics and analgesics consumption
Time frame: at 0 day, 1 day, 1 week, 2 weeks,1 month, 2 months, 3 months
intraoperative complications, PRF-related complications, esketamine-related complications
Time frame: 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
Contact information is provided by the study sponsor or research team.
Beijing Tiantan Hospital
Other
Esketamine Intravenous Infusion Combined With Pulsed Radiofrequency of Dorsal Root Ganglion for Acute and Subacute Herpes Zoster Neuralgia: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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