Health TrialsbyHealthPanel

Esketamine Combined With PRF of DRG for Postherpetic Neuralgia

ConditionPostherpetic Neuralgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages more than 18 years;

Pain persisting for over three months following the onset of the herpes zoster skin rash;

Lesions located in in the unilateral cervical, thoracic, and lumbosacral segments;

Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)； Planned to perform CT-guided PRF treatment of the Dorsal root ganglion（DRG）

Disqualifiers

Obstructive sleep apnoea syndrome;

Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.

A history of systemic immune diseases, organ transplantation, or cancers;

A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;

Trial design

Design model

Parallel

Treatments tested in this trial

  • esketamine+PRF treatment group

    Drug

    In the esketamine group, in addition to receiving PRF treatment+pregabalin, patients will also undergo a single intravenous infusion of esketamine.

  • PRF treatment group

    Drug

    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.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: esketamine groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Averaged weekly analgesic consumption

Averaged weekly consumption per analgesic of each participant for rescue analgesia

Time frame
up to 12 weeks
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Beijing Xiaotangshan Hospital

Collaborator

The First Hospital of Fangshan District,Beijing

Collaborator

Beijing Ditan Hospital

Collaborator

Hengshui People's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: