Postherpetic Neuralgia
Conditions
Interventions
Treatment group:Ozone Enema Combined with Conventional Treatment
(Equipment and ozone concentration: A medical ozone generator was used, and the ozone concentration was adjusted to 30 µg/mL.
Operation
Control group:Conventional treatment alone
(Pharmacotherapy: Pregabalin was administered at an initial dose of 75 mg twice a day, and the dose was adjusted appropriately according to the pain relief e
Basic nursing care: Health education was provided, and patients were instructed to avoid skin irritation in the affected areas, keep the skin clean and dry, maintain a regular work and rest schedule,
Sponsors
Shanghai Putuo District Central Hospital (Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for postherpetic neuralgia (PHN), with persistent pain for >= 3 months after herpes zoster rash resolution and a VAS score >= 3 points; 2.Aged 18 to 75 years, of any gender, with a clear consciousness and able to cooperate with pain assessment and treatment; 3.Have a definite herpes zoster-affected area, without severe skin infection, ulceration or local tissue damage; 4.Have not received ozone-related therapy or other invasive treatments that may affect pain assessment in the past month; 5.The patient and their family members fully understand the research purpose, methods, potential risks and benefits, and sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of allergy to ozone or consumables related to enema operation (e.g., catheters, lubricants); 2.Patients with underlying diseases such as severe cardiac, hepatic, renal or coagulation dysfunction, malignant tumors, or immunodeficiency diseases; 3.Patients with intestinal diseases (e.g., ulcerative colitis, intestinal obstruction, history of intestinal perforation) or severe anorectal lesions who cannot tolerate enema operation; 4.Pregnant or lactating women, patients with mental illnesses, or those with cognitive impairment; 5.Patients currently participating in other clinical studies, or those who have recently used drugs that may interfere with the therapeutic effect (e.g., potent analgesics, immunosuppressants) and cannot discontinue their use; 6.Patients with active infection, fever (body temperature > 38.5?), or other conditions that make them unfit for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity (VAS score); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity (NRS score);Self-rating depression scale (SDS);Self-rating anxiety scale (SAS) score;Serum inflammatory factors (IL-2, IL-6, IL-10, TNF-a, NK-1, B-EP, PGE2);Immune cells (CD series, NK cells);Intestinal flora-related indicators (floral species diversity and floral structural differences);Clinical total effective rate( calculated as the percentage of cases with significant relief plus partial relief relative to the total number of cases in the group, with statistical time points at 2 weeks after treatment and 1 month after follow-up.);Laboratory and physical examinations (routine blood test, liver and renal function (ALT, AST, Creatinine, Urea Nitrogen), coagulation function (PT, APTT), vital signs (body temperature, blood pressure, heart rate, respiratory rate));Adverse event recording (gastrointestinal reactions (abdominal pain, abdominal distension, diarrhea, anal discomfort), allergic reactions (skin rash, pruritus), neurological reactions (dizziness, somnolence) and other abnormal symptoms); | — |
Countries
China
Contacts
Public ContactYongqiang Zhu
Shanghai Putuo District Central Hospital (Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)
Outcome results
None listed