A Phase 1 interventional study of ultrasound-guided platelet rich plasma nerve block in PHN - Post-Herpetic Neuritis, sponsored by Affiliated Hospital of Nantong University. Completed at 1 site in China. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.
Sponsored by Affiliated Hospital of Nantong University · Phase 1, Interventional, and Treatment
used ultrasound-guided platelet rich plasma nerve block to treat Intractable Postherpetic Neuralgia.
Postherpetic neuralgia (PHN) is a kind of pain caused by varicella zoster virus invading the human body and infecting the corresponding ganglia. The affected ganglia are inflamed or even necrotic, affecting the nerve endings, the dorsal horn of the spinal cord and the sensory nerve tissues below, and the course of the disease is more than one month or more. Most patients can avoid PHN by timely and effective treatment in the acute herpes zoster period. However, some patients with intractable postherpetic neuralgia fail to receive timely and effective pain control treatment in the early stage of the disease, and the current commonly used clinical treatment methods often fail to achieve effective treatment results. Such patients often have a long course of disease, which can last for three to five years or even longer, Nerve damage is also more serious. Long term pain has seriously affected the quality of life of such patients. Therefore, how to quickly and effectively control pain has become the diagnosis and treatment goal of such patients with intractable post herpetic neuralgia. Platelet rich plasma (PRP) was widely used in muscle and bone repair due to its function of promoting tissue repair in the early stage. Recently, it was found that PrP can also promote nerve repair. Therefore, in order to further explore the therapeutic effect of PRP on refractory PHN patients, our department used ultrasound-guided platelet rich plasma nerve block to treat Intractable PHN.
73 studies on the registry are indexed under Neuritis; 20 are open to participants now.
This study's enrollment of 32 is below the median of 48 across 51 interventional studies indexed under Neuritis.
Browse Neuritis studies →Affiliated Hospital of Nantong University is the lead sponsor of 97 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
selected patients were treated by the ultrasound-guided platelet rich plasma nerve block once a week for the 4 consecutive weeks while they were given the regular medicine which are taking pregabalin and amitriptyline hydrochloride orally, and the dosage shall be increased or decreased according to the patient's condition.
Biological: ultrasound-guided platelet rich plasma nerve block
selected persons are treated by ultrasound-guided platelet rich plasma nerve block and the regular medicine
The changes from degree of pain that patients feel after the treatment are assessed by the numerical rating scale (NRS).
This method is composed of 11 numbers from 0 to 10. Patients use 11 numbers from 0 to 10 to describe the intensity of pain. (0="no pain"and 10=the "worst pain")
Time frame: Change from the numerical rating scale at 6 months
The changes from degree of pain that patients feel after the treatment are also assessed by the Short-form McGill Pain Questionnaire(SF-MPQ).
When evaluating item (1), ask the thinker questions one by one, and mark the corresponding level according to the pain level the thinker answers. When evaluating item (2), vas ruler shall be adopted. This ruler is a 10cm long swimming ruler with 10 graduations marked on one side and "0" and "10" at both ends, indicating no pain,"10" represents the most severe pain that the patient can't bear in his life. During clinical use, the side with scale is turned away from the patient, and the patient is asked to mark the corresponding position representing his pain level in the past day on the ruler. The evaluator evaluates the number of patients according to the position marked by the patient (for example, 5.4cm is 5.4 points), and records it in the table. When evaluating item (3), mark the corresponding score according to the patient's subjective feelings. Finally, the total scores of PRI, vas and PPI were evaluated. （The higher the total score, the more severe the pain）
Time frame: Change from the total score of Short-form McGill Pain Questionnaire at 6 months
The changes from degree of the patient' sleep quality after the treatment are assessed by the Athens Insomnia Scale.
Ask the examinee to carefully review his sleep experience in the past one month for questions ① - ⑧. If it happens to you at least three times a week, circle the corresponding self-assessment results. Then calculate the total score for evaluation. Assessment result judgment: (1) If the total score is less than 4, there is no sleep disorder: (2) if the total score is 4-6, it is suspected that there is a big sleep; (3) If the total score is above 6: Insomnia
Time frame: Change from the patient' sleep quality at 6 months
Plan to share: No
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Affiliated Hospital of Nantong University