Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.

NCT06410222 | Enrolling By Invitation

• 1 other identifier: TJ-JRB202402013
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Shingles is a neuropathic disease caused by varicella-herpes virus(VZV) invading nerves and accompanying pain.Currently, the treatment of postherpetic neuralgia (PHN) includes medication and minimally invasive interventional therapy.In patients with herpes zoster neuralgia treated with spinal cord stimulation (SCS), some patients have satisfactory pain relief after surgery, but some patients have pain symptoms again some time after surgery. The reason for this difference in treatment effect is not clear.

Conditions

Post Herpetic Neuralgia

Keywords

Herpes zoster; post-herpes zoster; spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• Pain recurrence

  The diagnostic criteria for pain recurrence at the site of postherpetic neuralgia were Numeric Rating Scales(NRS) score \> 4.

  up to 1 year

Secondary Outcomes (14)

• The time of electrodes placed in patients

  immediately after the surgery

• Surgical safety indicators

  after the surgery 3 days

• numeric rating scale(NRS)

  After spinal cord stimulation surgical 1 year

• numeric rating scale(NRS)

  Day 1 in the hospital

• numeric rating scale(NRS)

  the day before the spinal cord stimulation surgical

Interventions

Recurrence after undergo spinal cord stimulation PROCEDURE

1. To investigate the pain relief and recurrence of patients with herpes zoster neuralgia after spinal cord stimulation treatment. 2. To analyze the risk factors related to recurrence after spinal cord stimulation treatment in patients with herpes zoster neuralgia, and build a recurrence prediction model.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnostic criteria for PHN: \- In this study, the duration of herpes zoster eruption with pain was greater than or greater than 1 month.

You may qualify if:

• Age ≥18 years old.
• NRS score ≥4 points.
• The pain NRS of previous shingles area treated with SCS was ≤3, and the pain NRS was \> 4 after recurrence.

You may not qualify if:

• Serious cardiovascular and cerebrovascular diseases, such as heart failure, intracranial aneurysm, hypertension (high risk, very high risk).
• Epilepsy, suffering from mental illness.
• And patients who were lost to follow-up.

Sponsors & Collaborators

• Feng Gao: lead
• Shanxi Bethune Hospital: collaborator
• Wuhan No.1 Hospital: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The diagnostic criteria for pain recurrence at the site of postherpetic neuralgia were numerical rating scale(NRS) score \> 4

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: May 13, 2024
• Study Start: March 1, 2024
• Primary Completion: February 2, 2025
• Study Completion: April 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)