Fire needle plus cupping for acute herpes zoster: Study protocol for a randomised controlled trial

Abstract Abstract Background Herpes zoster (HZ) is a common skin disease caused by invasion of the varicella-zoster virus into the ganglia and skin. Severe pain caused by HZ seriously affects the normal life of patients; thus, pain often becomes the patient’s first complaint. Fire needle plus cupping may be effective for acute herpes zoster (AHZ), but the evidence is insufficient. Methods This is a three-arm randomized controlled trial with an observation time of 1 week. A total of 96 patients with AHZ pain are divided into three groups by stratified randomization, with 32 in each group: (a) fire needle + cupping (FC); (b) famciclovir + gabapentin (FG), famciclovir hydrochloride, 3 × 0.25 g/d orally (p.o.), with an individualized dose of gabapentin 900-3600 mg/d p.o.; and (c) fire needle + cupping + famciclovir (FCF). The above intervention lasts for 1 week, and all patients receive analgesia (nonopioid analgesics [analgin or paracetamol] and opioid analgesics [tramadol or morphine]). Groups a and c undergo 1 to 7 sessions of fire needles and cupping treatments per patient, with gabapentin and analgesic medication administered depending on the patient’s needs. The primary outcome measure is the assessment of changes in pain intensity before and after treatment (visual analogue scale ranging from 0-100 mm). Secondary outcome measures are changes in substance P and beta-endorphin concentrations in peripheral plasma before and after treatment. Quantitative scoring methods are used to evaluate the symptoms and physical signs before and after treatment, including pain classification, local itching, burning sensation, fever, local lymphadenopathy, skin lesion area, blisters, herpes clusters, vesicular traits, ulcers, and pimples. In addition, analgesic needs and side effects are evaluated. Discussion: The results of this study will be obtained by randomised controlled trial(RCT), and the outcomes will be analyzed and evaluated to prove FC may be effective for AHZ. Trial registration :The registration number is ChiCTR1800015372. Registered on 28 March 2018.