Table 1_Effect of transcranial magnetic stimulation on prognosis in patients with postherpetic neuralgia and comorbid depression undergoing interventional neuromodulation therapy: protocol for a randomized double-blind placebo-controlled trial.doc

BackgroundPostherpetic neuralgia (PHN) is often accompanied by depression, creating a vicious cycle that exacerbates symptoms and contributes to suboptimal treatment outcomes, even with interventional therapies. Repetitive transcranial magnetic stimulation (rTMS) has demonstrated potential in alleviating both pain and mood disturbances. However, its efficacy in enhancing prognosis when used alongside interventional neuromodulation therapy for PHN accompanied by depression remains inadequately explored and requires further investigation.
ObjectiveThis study aims to generate preliminary evidence on the efficacy and safety of rTMS in enhancing prognosis and alleviating pain in patients with PHN and mild to moderate depression undergoing interventional neuromodulation therapy.
MethodsThis study is a single-center, randomized, double-blind, placebo-controlled trial involving 174 adult patients with PHN. Participants will be randomly assigned, stratified by interventional neuromodulation therapy, to either the rTMS group (n=87) or the control group (n=87). Both groups will undergo either 10 Hz rTMS or sham stimulation for five consecutive days. The primary outcome is the incidence of poor prognosis at 3 months post-discharge. Secondary outcomes include the incidence of poor prognosis at 6 months post-discharge; Visual Analog Scale (VAS) sleep scores; short-form McGill Pain Questionnaire (SF-MPQ) scores; Self-Rating Depression Scale (SDS) scores; patient satisfaction; Pain Disability Index (PDI) scores; Multidimensional Fatigue Inventory-20 (MFI-20) scores; pregabalin oral doses; and the need for tramadol or antidepressants. Safety outcomes will include assessments of headache, pain at the stimulation site, neck pain, insomnia, muscle soreness, dizziness, nausea, tinnitus, irritability, tachycardia (heart rate > 100 bpm), and epilepsy. Data will be analyzed using a modified intention-to-treat approach.
DiscussionThis study aims to provide preliminary evidence on the efficacy and safety of 10 Hz rTMS in improving prognosis and alleviating pain in PHN patients with mild to moderate depression undergoing interventional pain management.
Trial registrationhttps://www.chictr.org.cn/bin/project/edit?pid=261070, identifier ChiCTR2500096978.