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Completed

NCT Number: NCT05444413

Platelet-rich Plasma in the Treatment of Intractable Postherpetic Neuralgia

used ultrasound-guided platelet rich plasma nerve block to treat Intractable Postherpetic Neuralgia.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria of PHN: have a history of acute herpes zoster, the pain lasts for more than half a year, and there is paroxysmal pain in the affected nerve distribution area;
  • Preoperative visual analog scale (VAS) score ≥ 5;
  • Those who can cooperate with the treatment;
  • We agreed to inject platelet rich plasma into nerve block under the guidance of ultrasound, and signed the informed consent form.

Exclusion criteria

  • Systemic infection or puncture local infection;
  • Serious disturbance of cardiovascular and cerebrovascular function;
  • Abnormal bleeding and coagulation function or complicated with blood system diseases;
  • Mental disorders;
  • Severe dysfunction of important organs in the body

Treatment and study plan

ultrasound-guided platelet rich plasma nerve block

Biological

selected persons are treated by ultrasound-guided platelet rich plasma nerve block and the regular medicine

Primary outcomes

  1. The changes from degree of pain that patients feel after the treatment are assessed by the numerical rating scale (NRS).

    Time frame: Change from the numerical rating scale at 6 months

    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")

Secondary outcomes

  1. The changes from degree of pain that patients feel after the treatment are also assessed by the Short-form McGill Pain Questionnaire(SF-MPQ).

    Time frame: Change from the total score of Short-form McGill Pain Questionnaire at 6 months

    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)

  2. The changes from degree of the patient' sleep quality after the treatment are assessed by the Athens Insomnia Scale.

    Time frame: Change from the patient' sleep quality at 6 months

    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

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

Effect of Ultrasound-guided Platelet-Rich Plasma Nerve Block Combined With Drugs in the Treatment of Intractable Postherpetic Neuralgia

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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