Platelet-rich Plasma in the Treatment of Intractable Postherpetic Neuralgia
Primary Purpose
PHN - Post-Herpetic Neuritis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ultrasound-guided platelet rich plasma nerve block
Sponsored by
About this trial
This is an interventional treatment trial for PHN - Post-Herpetic Neuritis focused on measuring platelet-rich plasma, Intractable postherpetic neuralgia
Eligibility Criteria
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
Sites / Locations
- Affiliated Hospital of Nantong University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ultrasound-guided platelet rich plasma nerve block combined with drugs
Arm Description
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.
Outcomes
Primary Outcome Measures
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")
Secondary Outcome Measures
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)
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
Full Information
NCT ID
NCT05444413
First Posted
June 23, 2022
Last Updated
September 6, 2022
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05444413
Brief Title
Platelet-rich Plasma in the Treatment of Intractable Postherpetic Neuralgia
Official Title
Effect of Ultrasound-guided Platelet-Rich Plasma Nerve Block Combined With Drugs in the Treatment of Intractable Postherpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
used ultrasound-guided platelet rich plasma nerve block to treat Intractable Postherpetic Neuralgia.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PHN - Post-Herpetic Neuritis
Keywords
platelet-rich plasma, Intractable postherpetic neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
patients with Intractable Postherpetic Neuralgia
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound-guided platelet rich plasma nerve block combined with drugs
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ultrasound-guided platelet rich plasma nerve block
Intervention Description
selected persons are treated by ultrasound-guided platelet rich plasma nerve block and the regular medicine
Primary Outcome Measure Information:
Title
The changes from degree of pain that patients feel after the treatment are assessed by the numerical rating scale (NRS).
Description
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
Secondary Outcome Measure Information:
Title
The changes from degree of pain that patients feel after the treatment are also assessed by the Short-form McGill Pain Questionnaire(SF-MPQ).
Description
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
Title
The changes from degree of the patient' sleep quality after the treatment are assessed by the Athens Insomnia Scale.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yuan zhou, doctor
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet-rich Plasma in the Treatment of Intractable Postherpetic Neuralgia
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