Platelet-rich Plasma in the Treatment of Intractable Postherpetic Neuralgia

NCT05444413 | Completed Phase 1

• 1 other identifier: 2022-K036
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PHN - Post-Herpetic Neuritis

Keywords

platelet-rich plasma; Intractable postherpetic neuralgia

Outcome Measures

Primary Outcomes (1)

• 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")

  Change from the numerical rating scale at 6 months

Secondary Outcomes (2)

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

  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.

  Change from the patient' sleep quality at 6 months

Study Arms (1)

ultrasound-guided platelet rich plasma nerve block combined with drugs

EXPERIMENTAL

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

Interventions

ultrasound-guided platelet rich plasma nerve block BIOLOGICAL

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

ultrasound-guided platelet rich plasma nerve block combined with drugs

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

Study Officials

• yuan zhou, doctor

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Model Details: patients with Intractable Postherpetic Neuralgia

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 5, 2022
• Study Start: March 3, 2022
• Primary Completion: May 3, 2022
• Study Completion: July 1, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)