Neuropathic Pain
Conditions
Interventions
Focused ultrasound 4W:Focused ultrasound 4W
Lidocaine cream group:Lidocaine cream
Focused ultrasound 6W:Focused ultrasound 6W
Focused ultrasound 2W:Focused ultrasound 2W
Sponsors
Shanghai Pudong New Area People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–80 years with chronic neuropathic pain (NPP) and cutaneous hyperalgesia, including but not limited to postherpetic neuralgia, diabetic peripheral neuropathy, traumatic nerve injury, phantom limb pain, and peripheral neuritis; 2.Disease duration of 1–12 months; 3.NRS score of 5–10 points; 4.Voluntary participation in this study, signed informed consent, good compliance, and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Skin lesions, redness, swelling, or scabbing in the treatment area that may interfere with ultrasound penetration; 2. Pain zones located around the eyes or mucous membranes; 3.Participation in other drug or device clinical trials within 4 weeks prior to randomization; 4.Known history of allergy to local anesthetics used in this protocol; 5. History of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency disorders, organ transplantation history, or use of immunosuppressive agents; 6.Pregnant or lactating patients;.women of childbearing potential with a positive baseline pregnancy test;.or women of childbearing potential unwilling to use effective contraception throughout the study; 7.Concomitant conditions judged by the investigator to pose a serious risk to patient safety or interfere with study completion (including but not limited to uncontrolled severe hypertension, severe diabetes, active infections, etc.); 8. History of established neurological or psychiatric disorders, including epilepsy or dementia; 9.Any other condition deemed by the investigator to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessment; | — |
Countries
China
Contacts
Public ContactShi Ying
Shanghai Pudong New Area People's Hospital
Outcome results
None listed