Acute Herpes Zoster NeuropathyNCT05538364
Epidural Platelet Rich Plasma Injection for Herpes Zoster
An observational study of Acute Herpes Zoster Neuropathy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Herpes zoster is a common disease, usually caused by the reactivation of latent varicella zoster virus from the dorsal root ganglion. Acute herpes zoster is characterized by severe pain and the appearance of vesicular skin rashes that usually heal in 2-3 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Herpes Zoster Neuropathy
- What is being tested?
- platelet rich plasma injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2022to 30 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending Accident and Emergency Department, Queen Mary Hospital, Hong Kong for herpes zoster.
Who may be able to join
- Age 18 years or above
- Average numerical rating scale (NRS) pain score over 3 out of ten over the week
- Onset of herpes zoster within 2 weeks
- Thoracolumbar herpes zoster
- Able to provide informed consent
Who cannot join
- Cervical and trigeminal herpes zoster
- Bilateral involvement of herpes zoster
- Using anticoagulant and/or antiplatelet medication (not including aspirin)
- Allergy: contrast dye, PRP, local anaesthetic
- pregnancy
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Stanley SC Wong, MBBS, (852)22553303, wongstan@hku.hk
About this study
Official title: Interlaminar Epidural Platelet Rich Plasma Injection for Acute Herpes Zoster: a Prospective Clinical Evaluation
Herpes zoster is a common disease, usually caused by the reactivation of latent varicella zoster virus from the dorsal root ganglion. Acute herpes zoster is characterized by severe pain and the appearance of vesicular skin rashes that usually heal in 2-3 weeks. One of the complications of acute herpes zoster is post-herpetic neuralgia (PHN), which is usually defined as persistent pain lasing 90 days or more from the onset of skin rash. The reported incidence of PHN ranges from between 5% to over 50%. PHN can negatively impact one's quality of life due to serious physical, psychological, functional, and social disturbances due to consequences of chronic pain. Platelet rich plasma (PRP) is an emerging treatment option for chronic pain. It is currently used predominantly for treating musculoskeletal pain conditions such as osteoarthritis and tendinopathies. However, PRP promotes the healing of nerve injury and reduces neuropathic pain, making it a potentially promising treatment option for neuropathic pain. The effect of interlaminar epidural PRP for PHN has not been studied. In this study, a case series will be performed to investigate the analgesic effect of interlaminar epidural PRP for patients with thoracic herpes zoster.
Read the detailed description
Herpes zoster is a common disease, usually caused by the reactivation of latent varicella zoster virus in the trigeminal or dorsal root ganglion. Acute herpes zoster is characterized by severe pain and the appearance of vesicular skin rashes that usually heal in 2-3 weeks. One of the complications of acute herpes zoster is post-herpetic neuralgia (PHN), which is usually defined as persistent pain lasing 90 days or more from the onset of skin rash. The reported incidence of PHN ranges from between 5 to over 50%, and pain severity can vary from mild to severe. PHN can negatively impact one's quality of life due to serious physical, psychological, functional, and social disturbances due to consequences of chronic pain. Most strategies to prevent PHN has been shown to be limited.
Epidural steroid injection is the most commonly used pain-relieving procedure in the world, and is also commonly used to treat herpes zoster pain. However, the analgesic efficacy of epidural steroid injection appears to be modest and duration limited. Repeated or continuous epidural blocks has been associated with reduced incidence of PHN. However, single epidural steroid injection did not provide benefit. This limits the use of epidural steroid injections because it is often logistically difficult to arrange multiple epidural blocks in real life clinical practice.
Platelet rich plasma (PRP) is an emerging treatment option for chronic pain. It is made from centrifugation of whole blood to increase the platelet concentration to 3-5 times greater than the physiological baseline. Proposed mechanism of PRP include enhancing the body's own healing response, delivery of growth factors, activation of mesenchymal stem cells, and modulation of inflammation. While epidural steroids reduce pain by reducing inflammation, PRP also promotes the healing of nerve injury and reduces neuropathic pain. Perineural PRP has been associated with reduced diabetic neuropathic pain. There are currently no studies that has investigated the analgesic effect of epidural PRP for herpes zoster pain and prevention of PHN. We plan conduct a prospective clinical evaluation to assess the analgesic effect of epidural PRP injection in patients with acute herpes zoster. We hypothesize that the healing effect and inflammatory modulatory effect of PRP would reduce herpetic pain and possibly reduce chronic neuropathic pain. Functional capacity, psychological well-being, health related quality of life, patient satisfaction, and analgesic consumption will also be assessed.
- Conditions
- Acute Herpes Zoster Neuropathy
- Being tested
- platelet rich plasma injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasma injectionBiological
Platelet rich plasma will be injected to the epidural space under light sedation using target-controlled infusion of propofol to an effect site concentration of between 0.5 to 1.5mcg/ml.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain intensity will be graded using numerical rating scale from 0 to 10 with 0 represents no pain and 10 represents the worst pain.
Measured: on postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Herpes Zoster NeuropathyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Sau Ching Stanley, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538364
- Sponsor's protocol ID
- UW22-518
- Status last verified
- May 2023
- First submitted
- 8 Sep 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interlaminar Epidural Platelet Rich Plasma Injection for Acute Herpes Zoster: a Prospective Clinical Evaluation
- ClinicalTrials.gov ID
- NCT05538364
- Acronym / sponsor ID
- UW22-518
- Conditions
- Acute Herpes Zoster Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Sep 2022 (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.
Herpes zoster is a common disease, usually caused by the reactivation of latent varicella zoster virus from the dorsal root ganglion. Acute herpes zoster is characterized by severe pain and the appearance of vesicular skin rashes that usually heal in 2-3 weeks. One of the complications of acute herpes zoster is post-herpetic neuralgia (PHN), which is usually defined as persistent pain lasing 90 days or more from the onset of skin rash. The reported incidence of PHN ranges from between 5% to over 50%. PHN can negatively impact one's quality of life due to serious physical, psychological, functional, and social disturbances due to consequences of chronic pain. Platelet rich plasma (PRP) is an emerging treatment option for chronic pain. It is currently used predominantly for treating musculoskeletal pain conditions such as osteoarthritis and tendinopathies. However, PRP promotes the healing of nerve injury and reduces neuropathic pain, making it a potentially promising treatment option for neuropathic pain. The effect of interlaminar epidural PRP for PHN has not been studied. In this study, a case series will be performed to investigate the analgesic effect of interlaminar epidural PRP for patients with thoracic herpes zoster.
Detailed description
Herpes zoster is a common disease, usually caused by the reactivation of latent varicella zoster virus in the trigeminal or dorsal root ganglion. Acute herpes zoster is characterized by severe pain and the appearance of vesicular skin rashes that usually heal in 2-3 weeks. One of the complications of acute herpes zoster is post-herpetic neuralgia (PHN), which is usually defined as persistent pain lasing 90 days or more from the onset of skin rash. The reported incidence of PHN ranges from between 5 to over 50%, and pain severity can vary from mild to severe. PHN can negatively impact one's quality of life due to serious physical, psychological, functional, and social disturbances due to consequences of chronic pain. Most strategies to prevent PHN has been shown to be limited.
Epidural steroid injection is the most commonly used pain-relieving procedure in the world, and is also commonly used to treat herpes zoster pain. However, the analgesic efficacy of epidural steroid injection appears to be modest and duration limited. Repeated or continuous epidural blocks has been associated with reduced incidence of PHN. However, single epidural steroid injection did not provide benefit. This limits the use of epidural steroid injections because it is often logistically difficult to arrange multiple epidural blocks in real life clinical practice.
Platelet rich plasma (PRP) is an emerging treatment option for chronic pain. It is made from centrifugation of whole blood to increase the platelet concentration to 3-5 times greater than the physiological baseline. Proposed mechanism of PRP include enhancing the body's own healing response, delivery of growth factors, activation of mesenchymal stem cells, and modulation of inflammation. While epidural steroids reduce pain by reducing inflammation, PRP also promotes the healing of nerve injury and reduces neuropathic pain. Perineural PRP has been associated with reduced diabetic neuropathic pain. There are currently no studies that has investigated the analgesic effect of epidural PRP for herpes zoster pain and prevention of PHN. We plan conduct a prospective clinical evaluation to assess the analgesic effect of epidural PRP injection in patients with acute herpes zoster. We hypothesize that the healing effect and inflammatory modulatory effect of PRP would reduce herpetic pain and possibly reduce chronic neuropathic pain. Functional capacity, psychological well-being, health related quality of life, patient satisfaction, and analgesic consumption will also be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending Accident and Emergency Department, Queen Mary Hospital, Hong Kong for herpes zoster.
Key inclusion criteria (5 listed)
- Age 18 years or above
- Average numerical rating scale (NRS) pain score over 3 out of ten over the week
- Onset of herpes zoster within 2 weeks
- Thoracolumbar herpes zoster
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Cervical and trigeminal herpes zoster
- Bilateral involvement of herpes zoster
- Using anticoagulant and/or antiplatelet medication (not including aspirin)
- Allergy: contrast dye, PRP, local anaesthetic
- pregnancy
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 |
|---|---|---|
| platelet rich plasma injectionPlatelet rich plasma will be injected to the epidural space under light sedation using target-controlled infusion of propofol to an effect site concentration of between 0.5 to 1.5mcg/ml. | Biological | – |
Primary outcome
Pain score
Time frame: on postoperative day 1
Pain intensity will be graded using numerical rating scale from 0 to 10 with 0 represents no pain and 10 represents the worst pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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.
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 Acute Herpes Zoster Neuropathy, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 5 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 10 May 2023. 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 Hong Kong. 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?
Contact Stanley SC Wong, MD, MBBS (22553303, wongstan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: on postoperative day 1). 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 10 May 2023.