Post Herpetic NeuralgiaNCT06410222
Predictive Models for the Treatment of Recurrent Herpes Zoster Neuralgia Following Spinal Cord Electrical Stimulation.
An observational study of Post Herpetic Neuralgia, run by Feng Gao at 1 site in China.
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)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Herpetic Neuralgia
- What is being tested?
- Recurrence after undergo spinal cord stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Post Herpetic Neuralgia
- Being tested
- Recurrence after undergo spinal cord stimulation
- Keywords
- Herpes zoster, post-herpes zoster, spinal cord stimulation
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurrence after undergo spinal cord stimulationProcedure or surgery
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain recurrence
The diagnostic criteria for pain recurrence at the site of postherpetic neuralgia were Numeric Rating Scales(NRS) score > 4.
Measured: up to 1 year
Secondary outcomes (14)
The time of electrodes placed in patients
record the time of spinal cord stimulation in spinal of patients.
Measured: immediately after the surgery
Surgical safety indicators
record the safety indicators during the spinal cord stimulation surgical ,include the displacement of electrodes and so on.
Measured: after the surgery 3 days
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.
Measured: After spinal cord stimulation surgical 1 year
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.
Measured: Day 1 in the hospital
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.
Measured: the day before the spinal cord stimulation surgical
C-reactive protein
An according to early infection stricture in serum.When CRP>20mg/l is considered abnormally level .
Measured: Day 1 in the hospital
Albumin
It is a protein that is found in many animal tissues and serum.The normal range 35-50g/L.
Measured: Day 1 in the hospital
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).
Measured: Day 1 in the hospital
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).
Measured: Day 1 in the hospital
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.
Measured: Day 1 in the hospital
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.
Measured: Day 1 in the hospital
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.
Measured: Day 1 in the hospital
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
Measured: Day 1 in the hospital
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.
Measured: Day 1 in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Mar 2024
- Primary completion2 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Herpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Bethune Hospital, Wuhan No.1 Hospital
- Responsible party
- Sponsor-investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410222
- Sponsor's protocol ID
- TJ-JRB202402013
- Status last verified
- May 2024
- First submitted
- 27 Mar 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06410222
- Acronym / sponsor ID
- TJ-JRB202402013
- Conditions
- Post Herpetic Neuralgia
- Keywords
- Herpes zoster, post-herpes zoster, spinal cord stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Collaborators
- Shanxi Bethune Hospital, Wuhan No.1 Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recurrence after undergo spinal cord stimulation1. 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. | Procedure or surgery | – |
Primary outcome
Pain recurrence
Time frame: up to 1 year
The diagnostic criteria for pain recurrence at the site of postherpetic neuralgia were Numeric Rating Scales(NRS) score > 4.
14 secondary outcomes
The time of electrodes placed in patients
Time frame: immediately after the surgery
Surgical safety indicators
Time frame: after the surgery 3 days
numeric rating scale(NRS)
Time frame: After spinal cord stimulation surgical 1 year
numeric rating scale(NRS)
Time frame: Day 1 in the hospital
numeric rating scale(NRS)
Time frame: the day before the spinal cord stimulation surgical
C-reactive protein
Time frame: Day 1 in the hospital
Albumin
Time frame: Day 1 in the hospital
diastolic blood pressure
Time frame: Day 1 in the hospital
systolic blood pressure
Time frame: Day 1 in the hospital
red blood cell count
Time frame: Day 1 in the hospital
eosinophilic granulocyte
Time frame: Day 1 in the hospital
erythrocyte sedimentation rate (ESR)
Time frame: Day 1 in the hospital
hemoglobin
Time frame: Day 1 in the hospital
neutrophilic granulocyte percentage
Time frame: Day 1 in the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Herpetic Neuralgia, run by Feng Gao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain recurrence (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.