This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) of dorsal root ganglion(DRG) against that of PRF monotherapy in patients with postherpetic neuralgia(PHN).
This study aims to determine whether the addition of esketamine to the PRF of DRG regimen can relieve pain in PHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory PHN patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
186
In the esketamine group, in addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine.
In the control group, patients will receive PRF treatment. PRF will be performed on DRG by an designated physician in each participating center. The patients 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 will be carefully inserted until the needle tip reached the upper edge of the intervertebral foramen under the guidance of three-dimensional (3D) CT. PRF treatment (PMG-230, Baylis Medical Inc.) targeting to DRG will be applied for 900 seconds. The parameters of PRF treatment will be set at 42 ℃, 2 Hz with 20 milliseconds current. Regarding pregabalin, the dosage is titrated based on patients'pain intensity and tolerance. This process fully accounts for individual patient differences to optimize treatment outcomes.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
The primary comparison is the difference between the means of the daily mean pain scores over the first 7 days, measured on an 11-point NRS
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: 7-day period
average weekly NRS score
Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain
Time frame: up to 12 weeks
Averaged weekly analgesic consumption
Averaged weekly consumption per analgesic of each participant for rescue analgesia
Time frame: up to 12 weeks
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 the end of weeks1, 2, 4, 8, and 12 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 the end of weeks 1,2, 4, 8, and 12 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 the end of weeks 1,2 4, 8, and 12 after treatment
The Hospital Anxiety and Depression Scale (HADS)
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It consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.
Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment
Safety assessments
intraoperative complications, PRF-related complications, Eskatamine-related complications, Pregabaline-related complications
Time frame: Conducted on Day 0, Day 1, Day 3, and at the end of weeks 1, 2, 4, 8, and 12 after treatment
success rate
The success rate is defined as more than a 50% reduction in NRS-11 score.
Time frame: At the end of weeks 1, 2, 4, 8, and 12 after treatment