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Not yet recruitingNCT06914206Updated Apr 9, 2025

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

An interventional study of esketamine group and PRF group in Herpes Zoster, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Herpes Zoster by Beijing Tiantan Hospital — 11 open to participants now, 12 under way, none of them phase 3. Herpes Zoster · Beijing Tiantan Hospital.

Planned enrollment
10th of 12
184 · median 750
Started
2025
with 10 others
No phase
12 of 12
11 open now
Primary completion
2026-04
later than 0 of 11 live
Registered
3rd of 12
by date

Among the 12 studies in Herpes Zoster by Beijing Tiantan Hospital, this one is the 10th largest by planned enrollment, is one of 11 that started in 2025, is one of 12 with no phase, reaches primary completion later than 0 of the 11 other live ones, and was the 3rd registered.

Herpes Zoster

299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.

Browse Herpes Zoster studies →

Open to participants now

11 of the 12 studies in Herpes Zoster by Beijing Tiantan Hospital are open now, in 1 country. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

China11

All 11 open studies →

Where they have run

China12

Who these studies take

Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Herpes Zoster

Browse trials for

Keywords

  • Herpes Zoster Neuralgia
  • Esketamine
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ages more than 18 years;
  2. Patients with onset of herpes zoster (HZ) rash less than 90 days;
  3. HZ affected the spinal nerves (cervical/thoracic/lumbar nerve);
  4. Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)；
  5. Planned to perform CT-guided PRF treatment of the dorsal root ganglion(DRG).

Exclusion criteria

Exclusion Criteria:

  1. Obstructive sleep apnoea syndrome;
  2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of DRG.
  3. A history of systemic immune diseases, organ transplantation, or cancers;
  4. A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
  5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
  6. Comorbid hyperthyroidism or phaeochromocytoma;
  7. Recent history of drug abuse;
  8. Having to esketamine;
  9. Communication difficulties.
  10. Women who are preparing for pregnancy, in the pregnancy or lactation period.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
184 participants (estimated)

Study arms

  • Experimental
    Esketamine group

    Esketamine+ PRF group

    Drug: esketamine group

  • Active comparator
    control group

    PRF group

    Drug: PRF group

Interventions

  • Drugesketamine group

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

    Also known as: esketamine+PRF+ standardized drug treatment

  • DrugPRF group

    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

    Also known as: PRF+standardized drug treatment

06

What researchers measure

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

  5. Analgesics consumption

    the type of analgesics and analgesics consumption

    Time frame: at 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment

  6. Safety assessments

    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

  7. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — not yet decided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2025; primary completion for Apr 2026, 12 months later.

Of 34 interventional studies with no phase under Herpes Zoster, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 12 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2025
First posted
Apr 6, 2025
StartEst.
Apr 1, 2025
Primary completionEst.
Apr 1, 2026
CompletionEst.
Jul 1, 2026
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06914206
Lead sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Xiaotangshan Hospital, The First Hospital of Fangshan District,Beijing, Beijing Ditan Hospital, Hengshui People's Hospital
Responsible party
Fang Luo (Director of Department of Day surgery and Pain Management, Beijing Tiantan Hospital) — Principal investigator
First posted
Apr 6, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Apr 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Apr 9, 2025

Study contacts

Fang Luo
Contact
13611326978@163.com
+86 13611326978

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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