Investigating the Therapeutic Effect of Intradermal Acupuncture for Acute Herpes Zoster and Assessing the Feasibility of Infrared Thermography for Early Prediction of Postherpetic Neuralgia: Study Protocol for a Randomized, Sham-Controlled, Clinical Trial.

Introduction: Herpes zoster (HZ) can adversely influence patients' quality of life and sometimes it can develop postherpetic neuralgia (PHN). To date, it remains challenging to be managed by currently available therapies. Intradermal acupuncture (IDA) has the potential to be an adjunctive therapy for acute HZ and infrared thermography (IRT) may be useful for predicting PHN; however, current evidence remains inconclusive. Therefore, the purposes of this trial are to 1) evaluate the efficacy and safety of IDA as an adjunctive therapy for acute HZ; 2) to explore the feasibility of IRT for early prediction of PHN and as an objective tool to aid in subjective pain assessment in acute HZ. Methods: This study is designed as a randomized, parallel-group, sham-controlled, and patient-assessor-blinded trial, including 1-month treatment and 3-month follow-ups. Seventy-two qualified participants will be randomly split into the IDA or sham IDA group in a ratio of 1:1. Apart from standard pharmacological treatments in both groups, the two groups will receive 10 sessions of IDA or sham IDA, respectively. Primary outcome measures are the visual analog scale (VAS), indicators of herpes lesions' recovery, the temperature of the pain area, and the incidence rate of PHN. The secondary outcome is the 36-item Short Form Health Survey (SF-36). Indicators of herpes lesions' recovery will be assessed at each visit and follow-ups. The remaining outcomes will be assessed at baseline, 1 month after intervention, and 3-month follow-up. Safety evaluation will be determined by adverse events during the trial. Conclusion: Expected results will determine whether IDA can enhance therapeutic effectiveness of pharmacotherapy for acute HZ with acceptable safety profile. In addition, it will verify the accuracy of IRT for early prediction of PHN and as an objective tool of subjective pain for acute HZ. Trial Registration: Clinicaltrials.gov (identification number: NCT05348382; Registered 27 April 2022, https://clinicaltrials.gov/ct2/show/NCT05348382).