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

Post Herpetic Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06410222
• Other study ID #: TJ-JRB202402013
• Status: Enrolling by invitation
• Start date: March 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: April 1, 2025
• Est. primary completion date: February 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Post Herpetic Neuralgia

Intervention

Procedure:
• Recurrence after undergo spinal cord stimulation
To investigate the pain relief and recurrence of patients with herpes zoster neuralgia after spinal cord stimulation treatment. 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.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Feng Gao	Shanxi Bethune Hospital, Wuhan No.1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The time of electrodes placed in patients	record the time of spinal cord stimulation in spinal of patients.	immediately after the surgery
Secondary	Surgical safety indicators	record the safety indicators during the spinal cord stimulation surgical ,include the displacement of electrodes and so on.	after the surgery 3 days
Secondary	numeric rating scale(NRS)	The 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.	After spinal cord stimulation surgical 1 year
Secondary	numeric rating scale(NRS)	The 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.	Day 1 in the hospital
Secondary	numeric rating scale(NRS)	The 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.	the day before the spinal cord stimulation surgical
Secondary	C-reactive protein	An according to early infection stricture in serum.When CRP>20mg/l is considered abnormally level .	Day 1 in the hospital
Secondary	Albumin	It is a protein that is found in many animal tissues and serum.The normal range 35-50g/L.	Day 1 in the hospital
Secondary	diastolic blood pressure	An 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).	Day 1 in the hospital
Secondary	systolic blood pressure	A 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).	Day 1 in the hospital
Secondary	red blood cell count	The 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.	Day 1 in the hospital
Secondary	eosinophilic granulocyte	Eosinophils 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.	Day 1 in the hospital
Secondary	erythrocyte sedimentation rate (ESR)	the 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.	Day 1 in the hospital
Secondary	hemoglobin	Hemoglobin 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	Day 1 in the hospital
Secondary	neutrophilic granulocyte percentage	The 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.	Day 1 in the hospital