- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538364
Epidural Platelet Rich Plasma Injection for Herpes Zoster
Interlaminar Epidural Platelet Rich Plasma Injection for Acute Herpes Zoster: a Prospective Clinical Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stanley SC Wong, MD, MBBS
- Phone Number: 22553303
- Email: wongstan@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Stanley SC Wong, MBBS
- Phone Number: (852)22553303
- Email: wongstan@hku.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
on postoperative day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW22-518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Herpes Zoster Neuropathy
-
NobelpharmaCompleted
-
Tanta UniversityNot yet recruitingAcute Herpes Zoster Pain Managment
-
Centrexion TherapeuticsTerminatedAcute-onset Herpes Zoster PainAustralia
-
ContraVir Pharmaceuticals, Inc.Completed
-
University of California, San FranciscoCompleted
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineCanada, Spain, Korea, Republic of, United Kingdom, France, Czechia
-
Merck Sharp & Dohme LLCCompletedHerpes Zoster | Herpes Zoster-related Complications
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineUnited States, Estonia, Canada
-
Ohio State UniversityCompletedHerpes Zoster DiseaseUnited States
Clinical Trials on platelet rich plasma injection
-
Stanford UniversityPartnership for Clean CompetitionCompletedRheumatic Diseases | TendinopathyUnited States
-
Komzak Martin, M.D.CompletedCartilage DegenerationCzech Republic
-
Annah J. VollstedtActive, not recruitingUrinary Incontinence | Urinary Incontinence,StressUnited States
-
University of Toledo Health Science CampusActive, not recruiting
-
Assiut UniversityCompletedOsteo Arthritis Knee | Pain, ChronicEgypt
-
Istituto Clinico HumanitasIstituto Ortopedico RizzoliRecruitingOsteoarthritis, KneeItaly
-
Singapore General HospitalNot yet recruitingLateral Epicondylitis, Unspecified Elbow
-
Ministry of Health, KuwaitNot yet recruitingOsteochondral Lesions of the Talus
-
Reproductive Medicine Associates of New JerseyCompletedInfertility, Female | Ovarian FailureUnited States, Turkey
-
Ohio State UniversityWithdrawnKnee Pain Chronic | Pes Anserinus Bursitis | Status-Post Total Knee ArthroplastyUnited States