Clinical trial NCT06410222: Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Post Herpetic Neuralgia
Keywords: Herpes zoster
post-herpes zoster
spinal cord stimulation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Shanxi Bethune Hospital
name: Wuhan No.1 Hospital
First posted: 2024-05-13
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain recurrence
timeFrame: up to 1 year
Secondary outcomes:
measure: The time of electrodes placed in patients
timeFrame: immediately after the surgery
measure: Surgical safety indicators
timeFrame: after the surgery 3 days
measure: numeric rating scale(NRS)
timeFrame: After spinal cord stimulation surgical 1 year
measure: numeric rating scale(NRS)
timeFrame: Day 1 in the hospital
measure: numeric rating scale(NRS)
timeFrame: the day before the spinal cord stimulation surgical
measure: C-reactive protein
timeFrame: Day 1 in the hospital
measure: Albumin
timeFrame: Day 1 in the hospital
measure: diastolic blood pressure
timeFrame: Day 1 in the hospital
measure: systolic blood pressure
timeFrame: Day 1 in the hospital
measure: red blood cell count
timeFrame: Day 1 in the hospital
measure: eosinophilic granulocyte
timeFrame: Day 1 in the hospital
measure: erythrocyte sedimentation rate (ESR)
timeFrame: Day 1 in the hospital
measure: hemoglobin
timeFrame: Day 1 in the hospital
measure: neutrophilic granulocyte percentage
timeFrame: Day 1 in the hospital
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: