A Comparative Study of Intradermal Injection of Exosomes, Platelet-Rich Plasma and Steroids in the Treatment of Post-Herpetic Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Pain Severity Using the Visual Analog Scale
研究概览
简要总结
This randomized controlled clinical trial will evaluate and compare the efficacy and safety of intradermal injection of exosomes, platelet-rich plasma, and corticosteroid in patients with post-herpetic neuralgia. Forty-five adult patients with dermatomal pain persisting for at least 90 days after herpes zoster will be enrolled from outpatient clinics. Participants will be assigned to one of three groups: intradermal exosome injection, intradermal autologous platelet-rich plasma injection, or intradermal triamcinolone acetonide injection. Each group will receive four treatment sessions every two weeks. Outcomes will include pain severity, neuropathic pain characteristics, quality of life, patient satisfaction, and adverse effects, assessed at baseline, at the final session, and during follow-up visits at 3 and 6 months after the last session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study; participants and investigators are not masked to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with post-herpes zoster persistent dermatomal pain consistent with post-herpetic neuralgia for at least 90 days.
- •Male or female patients. Age 18 years or older. Willingness to comply with study procedures and attend follow-up visits. Ability and willingness to provide written informed consent
排除标准
- •History of hypersensitivity to any of the study treatments. Pregnancy. Any type of skin infection involving the affected dermatome. Immunocompromised patients, including patients with cancer or HIV. Patients with bone marrow aplasia. Patients with known bleeding tendency, platelet dysfunction, or thrombocytopenia, defined as platelet count less than 150 × 10⁹/L.
- •Regular use of anticoagulant or antiplatelet drugs.
研究组 & 干预措施
Exosomes
Participants will receive intradermal injections of exosome product into the affected dermatome. The dermatome will be marked and divided into 1 cm² squares, and 0.1 cc will be injected intradermally into each square using an insulin syringe. Treatment will be given every two weeks for a total of four sessions, followed by visits at 3 and 6 months after the last session.
干预措施: Exosomes (Biological)
PRP
Participants will receive intradermal injections of autologous platelet-rich plasma into the affected dermatome. Ten mL of blood will be collected under aseptic conditions and centrifuged at 1000 rpm for 10 minutes. The lower 1-2 cc of plasma will be used as platelet-rich plasma concentrate. The affected dermatome will be marked into 1 cm² squares, and 0.1 cc PRP will be injected intradermally into each square. Treatment will be given every two weeks for four sessions, followed by visits at 3 and 6 months after the last session.
干预措施: PRP (Biological)
Corticosteroids
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Change in Pain Severity Using the Visual Analog Scale
时间窗: Baseline and final treatment session, approximately 6 weeks after baseline
次要结局
- Change in Neuropathic Pain Scale Score(Baseline, final treatment session, 3 months after last session, and 6 months after last session)
研究者
Mona El Radi Kamal Mohamed Emam
Dr
Zagazig University