Postherpetic Neuralgia
Conditions
Brief summary
Pharmacotherapy is the cornerstone of Postherpetic Neuralgia (PHN) management. First-line treatments for PHN include antiviral agents (e.g., acyclovir, valacyclovir, famciclovir, and brivudine), centrally acting antiepileptic drugs (pregabalin and gabapentin), antidepressants (duloxetine and venlafaxine), and peripherally acting sodium-channel blockers (lidocaine patches). In recent years, substantial progress has been made in the prevention and treatment of PHN, including early and active antiviral therapy (acyclovir, valacyclovir, famciclovir, brivudine, etc.), analgesic therapy (calcium-channel modulators such as pregabalin and gabapentin; tricyclic antidepressants such as amitriptyline; and opioid analgesics), interventional procedures (e.g., radiofrequency modulation and spinal cord stimulation), and vaccination. Nevertheless, clinical outcomes remain unsatisfactory, with the incidence of refractory PHN still exceeding 50%. Adverse effects associated with certain first- and second-line medications (such as antidepressants and anticonvulsants), as well as the potential risk of opioid dependence, markedly reduce treatment adherence. This situation has compelled clinicians to continually seek new and effective therapeutic approaches for PHN. Non-invasive transcranial stimulation, as an emerging noninvasive neuromodulation technique, enables targeted modulation of deep brain structures. Animal studies have demonstrated that it can noninvasively regulate neuronal firing in deep regions and induce long-term plasticity, while offering relatively high spatial selectivity and tissue penetration. These features suggest broad clinical potential in chronic pain and affective disorders.
Interventions
Non-invasive transcranial stimulation is delivered once daily for 30 minutes for 10 consecutive days. Stimulation is administered using a multi-channel battery-powered device with five circular Ag/AgCl electrodes; current output is monitored in real time for safety.
Sham procedure with identical electrode placement and session duration (30 minutes once daily for 10 consecutive days). After an initial brief stimulation to mimic sensation, the current output is turned off.
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥ 18 years. * Diagnosis of postherpetic neuralgia (PHN) with disease duration ≥ 3 months. * NRS pain score ≥ 4. * Willing to receive the intervention and able to provide written informed consent.
Exclusion criteria
* Contraindications to electrical stimulation (e.g., intracranial metal implants, cardiac pacemaker). * History of epilepsy, severe psychiatric disorder, or cognitive impairment. * Pregnant or breastfeeding women. * Unable to comply with the intervention procedures and follow-up assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (NRS) | Baseline, Day 10 (end of treatment), 1 month, and 3 months | Numeric Rating Scale (NRS, 0-10); change from baseline in pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain symptoms | Baseline, Day 10, 1 month, 3 months | Neuropathic Pain Symptom Inventory (NPSI); change from baseline. |
| Pain interference | Baseline, Day 10, 1 month, 3 months | Brief Pain Inventory (BPI) interference subscale; change from baseline. |
| Health-related quality of life | Baseline, Day 10, 1 month, 3 months | EuroQol-5 Dimension (EQ-5D); change from baseline. |
| Sleep quality | Baseline, Day 10, 1 month, 3 months | Medical Outcomes Study Sleep Scale (MOS-SS); change from baseline. |
| Emotional status | Baseline, Day 10, 1 month, 3 months | Generalized Anxiety Disorder-7 (GAD-7); change from baseline.Edinburgh Postnatal Depression Scale-10 (EPDS-10) or prespecified depression scale; change from baseline.Pain Catastrophizing Scale (PCS); change from baseline. |
| Global impression | Day 10, 1 month, 3 months | Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) at follow-up visits. |
Countries
China