Post-burn itch
Conditions
Interventions
Sham:Sham stimulation(The intensity decreased from that with sensation to 0, 30min per day for 7days)
TENS:Transcutaneous nerve electrical stimulation(The maximum intensity that can be tolerated, 30min per day for 7days)
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation with written informed consent. 2.Aged 18–60 years, regardless of gender. 3.Clinically confirmed moderate-to-severe pruritus (WINRS score >= 4) secondary to isolated extremity burn wounds (>= 90% healed or >= 4 weeks post the last skin grafting) or burn scars with distinguishable boundary (area = 1 week . 4.Inadequate response (WINRS score >= 4) or intolerance to conventional itch treatment ( >= 1 week of antihistamines, etc.). 5.Sufficient literacy and comprehension skills to independently complete assessment scales.
Exclusion criteria
Exclusion criteria: 1.Pruritus caused by other skin lesions (e.g., eczema, dermatitis, allergies, infections) or systemic conditions (e.g., diabetes, long-term dialysis). 2.Concurrent use of other neuromodulation therapies ((e.g., transcranial magnetic/electrical stimulation) or medications ((e.g., systemic/topical corticosteroids) potentially interfering with TENS. 3.Pregnancy, lactation, or planned pregnancy during the trial. 4.History of epilepsy or seizure disorders. 5.Presence of cardiac pacemakers or metal implants. 6.Severe comorbidities (e.g., chronic hepatic/renal dysfunction, pulmonary infections). 7.With unstable vital signs. 8.With contraindications to TENS: hemorrhagic tendency, coagulopathy, acute suppurative skin infection, local spastic paralysis, local unhealed wounds, malignancy, post-stroke spasticity, severe cognitive impairment, impaired consciousness, or abnormal neural excitability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day itching improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of the ISS and NRS score;Change of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS ) score;Improvement of sleep disorder;Quality of life;Scar severity;Incidence of adverse events;Skin function parameters(Exploring indicator);Neuroimaging changes(Exploring indicator); | — |
Countries
China
Contacts
Public ContactHaisheng Li
The First Affiliated Hospital of Army Medical University
Outcome results
None listed