Health TrialsbyHealthPanel

Esketamine Combined With PRF of DRG for Acute/Subacute Zoster-associated Pain

ConditionHerpes Zoster
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages more than 18 years;

Patients with onset of herpes zoster (HZ) rash less than 90 days;

HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);

Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)；

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 group

    Drug

    in addition to receiving the combination of PRF of DRG and standardized drug treatment, patients will also undergo a single intravenous infusion of esketamine.

  • PRF group

    Drug

    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

Treatment groups

184 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 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

Secondary outcomes

1

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
2

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
3

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
4

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

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: