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

Risk Factor Analysis and Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Short-course Spinal Cord Electrical Stimulation: a Multicenter, Retrospective, Observational Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06410222
Enrollment
300
Registered
2024-05-13
Start date
2024-03-01
Completion date
2025-04-01
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Herpetic Neuralgia

Keywords

Herpes zoster, post-herpes zoster, spinal cord stimulation

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.

Detailed description

Shingles is a neuropathic disease caused by varicella-herpes virus(VZV) invading nerves and accompanying pain. About 3\ 5/1000 people suffer from shingles every year in the world, and 2.9\ 5.8/1000 people over the age of 50 in China suffer from shingles every year, with an annual growth rate of 2.5\ 5.0%. If acute herpes zoster can not be treated effectively, it will be transformed into postherpetic neuralgia (PHN), patients will suffer long-term knife, needle, burning pain as well as hyperalgesia, touch induced pain and skin paresthesia, which seriously affect the daily life of patients. It also causes a huge social and economic burden.Currently, the treatment of postherpetic neuralgia (PHN) includes medication and minimally invasive interventional therapy. The European Neurological Association has proposed guidelines for first - and second-line drug treatment of herpes zoster neuralgia with level A evidence. At the same time, some patients are relieved by interventional therapy, such as injection therapy (local injection, peripheral nerve block, stellar ganglion block), nerve stimulation therapy (percutaneous electrical nerve stimulation, peripheral nerve stimulation, pulsed radiofrequency), spinal cord stimulation (SCS), and spinal dorsal horn ganglion destruction. In 1976, spinal cord stimulation (SCS) was first used to treat patients with nociceptive pain. It is to place the stimulation electrode around the diseased nerve for a certain time, frequency, and voltage adjustment, so as to relieve pain. At present, spinal cord stimulation (SCS) has been widely used and studied in the treatment of postherpetic neuralgia (PHN) at home and abroad, and its mechanism of action may be related to the gate control theory of pain : in the dorsal horn of the spinal cord, α fiber can inhibit the pain signal transmitted by C fiber, and spinal cord stimulation (SCS) may regulate the transmission of pain signal through this mechanism. At the same time, spinal cord stimulation (SCS) can also affect the levels of gamma-aminobutyric acid and adenosine in the dorsal horn, thereby reducing neuropathic pain.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. Therefore, this study intends to retrospectively analyze the clinical data of patients with and the risk factors for recurrence after treatment, and then construct a prognostic prediction model to provide evidence and reference for clinical treatment of postherpetic neuralgia (PHN).

Interventions

PROCEDURERecurrence after undergo spinal cord stimulation

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.

Sponsors

Shanxi Bethune Hospital
CollaboratorOTHER
Wuhan No.1 Hospital
CollaboratorOTHER
Feng Gao
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain recurrenceup to 1 yearThe diagnostic criteria for pain recurrence at the site of postherpetic neuralgia were Numeric Rating Scales(NRS) score \> 4.

Secondary

MeasureTime frameDescription
Surgical safety indicatorsafter the surgery 3 daysrecord the safety indicators during the spinal cord stimulation surgical ,include the displacement of electrodes and so on.
numeric rating scale(NRS)After spinal cord stimulation surgical 1 yearThe NRS pain Score is an exponential scale that uses 0 to 10 to represent different levels of pain, 0 being painless and 10 being severe, and asks the patient how bad the pain is, or to circle a number that best represents their pain.
C-reactive proteinDay 1 in the hospitalAn according to early infection stricture in serum.When CRP\>20mg/l is considered abnormally level .
AlbuminDay 1 in the hospitalIt is a protein that is found in many animal tissues and serum.The normal range 35-50g/L.
diastolic blood pressureDay 1 in the hospitalAn indicator in blood pressure measurement that indicates the pressure of the heart's arterial blood against the vessel walls during diastole. It is usually measured in millimeters of mercury (mmHg).
The time of electrodes placed in patientsimmediately after the surgeryrecord the time of spinal cord stimulation in spinal of patients.
red blood cell countDay 1 in the hospitalThe red blood cell count (RBC count) is a measurement of the number of red blood cells present in a microliter (μL) of blood.For males: 4.5 to 5.9 million cells per microliter (μL) of blood.For females: 4.0 to 5.2 million cells per microliter (μL) of blood.
eosinophilic granulocyteDay 1 in the hospitalEosinophils are a type of white blood cell, specifically a subtype of granulocyte, characterized by the presence of eosinophilic granules in their cytoplasm. The normal range for eosinophils is typically between 0% and 6% of the total white blood cell count, though this can vary slightly depending on the laboratory's reference values and the individual's age and health status.
erythrocyte sedimentation rate (ESR)Day 1 in the hospitalthe sedimentation rate or sed rate, is a test that measures the rate at which red blood cells (erythrocytes) settle in a tube of blood over a specific period of time.
hemoglobinDay 1 in the hospitalHemoglobin is a protein found in red blood cells that is responsible for transporting oxygen from the lungs to the rest of the body's tissues and organs, and for carrying carbon dioxide back to the lungs for exhalation.The normal range of hemoglobin levels for adult males: 13.8 to 17.2 grams per deciliter (g/dL). adult females: 12.1 to 15.1 g/dL
neutrophilic granulocyte percentageDay 1 in the hospitalThe neutrophilic granulocyte percentage, often referred to simply as neutrophil percentage or neutrophil count, is a measure of the proportion of neutrophils in the total white blood cell count.a normal neutrophil percentage typically falls within the range of approximately 40% to 75% of the total white blood cell count.
systolic blood pressureDay 1 in the hospitalA type of blood pressure that refers to the pressure of blood against the artery walls when the heart contracts. It is often used as a measure of cardiovascular health(mmHg).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026