A Standardized Nursing-Led Protocol Integrated Pain, Sleep, Medication Adherence, and Symptom Management in Postherpetic Neuralgia

Summary

This prospective randomized controlled trial evaluated an eight-week standardized nursing-led protocol integrating pain assessment, sleep monitoring, medication-adherence support, and rule-based digital symptom monitoring for postherpetic neuralgia. Compared with usual care, the protocol was associated with greater improvement in pain, sleep, medication adherence, and symptom burden.

Abstract

Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition after herpes zoster that frequently coexists with sleep disturbance, medication-related problems, and fluctuating symptoms. This study evaluated whether a standardized nursing-led protocol could improve multidimensional short-term outcomes beyond usual care. In this prospective, parallel-group randomized controlled trial, 128 adults with PHN were allocated 1:1 to usual care or usual care plus an eight-week protocol integrating structured pain assessment, sleep monitoring, medication-adherence support, and rule-based digital symptom monitoring. The primary outcome was the between-group difference in change in Numeric Rating Scale (NRS) pain score from baseline to Week 8. Secondary outcomes included Pittsburgh Sleep Quality Index (PSQI), MMAS-8 medication adherence, symptom burden, pain-related nocturnal awakenings, breakthrough pain, rescue analgesic use, adverse events, rule-based alerts, and nursing satisfaction. Week-8 data were available for 116 participants (57 usual care; 59 protocol). Mean NRS scores decreased from 7.19 ± 1.08 to 4.82 ± 1.53 in the usual-care group and from 7.28 ± 1.05 to 3.24 ± 1.28 in the protocol group. An NRS reduction of at least 2 points occurred in 49.1% and 76.3% of participants, respectively. The protocol group also showed larger improvements in PSQI, MMAS-8, symptom burden, and nocturnal awakenings, with fewer breakthrough-pain episodes and less rescue-analgesic use. These findings support further evaluation of the standardized nursing-led protocol in preregistered multicenter trials with intention-to-treat analyses and longer follow-up.

Introduction

Postherpetic neuralgia (PHN) is neuropathic pain that persists or recurs in the affected dermatome after herpes zoster caused by varicella-zoster virus. A threshold of at least 3 months after rash onset is commonly used to distinguish PHN from subacute herpetic neuralgia¹. Peripheral nerve injury, ectopic activity, and central sensitization contribute to persistent pain, allodynia, and hyperalgesia^2,3,4. PHN can substantially impair sleep and daily function, and sleep disruption may in turn amplify pain sensitivity⁵.

Protocol

This prospective, parallel-group randomized controlled trial was conducted at the Department of Pain, Affiliated Hospital of Guizhou Medical University. The overall study conduct period extended from 2 January 2024 to 31 December 2025. The study was conducted in accordance with the Declaration of Helsinki. The study protocol was reviewed and approved by the Human Experimental Ethics Committee of Guizhou Medical University (Approval No. 2024 Ethics Review [154]). All participants provided written informed consent before enrollment. When caregiver assistance was required for study procedures, the participant’s own written informed consent remained mandatory and th....

Results

Participant flow and analysis populations

Screening, enrollment, and follow-up completion

A total of 148 individuals were assessed for eligibility. Twenty were excluded before randomization: 8 did not meet diagnostic or symptom-severity criteria, 5 had a major coexisting pain condition, 4 did not complete the baseline assessment, and 3 declined participation. The remaining 128 participants were randomized equally to the usual-care a.......

Discussion

In this prospective randomized trial, the standardized nursing-led protocol was associated with greater eight-week improvement in pain and several secondary outcomes than usual care. The difference in mean NRS reduction and the larger proportion achieving an absolute ≥2-point improvement support the primary clinical signal. The protocol did not replace physician-directed treatment; it standardized how nurses assessed symptoms, reinforced adherence, monitored sleep and adverse effects, and escalated predefined conce.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
10-item nursing satisfaction questionnaire	Study-developed	Study-specific instrument	Week-8 nursing satisfaction assessment using a study-developed 10-item questionnaire
Amitriptyline	Hospital pharmacy	Not applicable	Physician-prescribed neuropathic-pain treatment
Duloxetine	Hospital pharmacy	Not applicable	Physician-prescribed neuropathic-pain treatment
Electronic data-capture system	Affiliated Hospital of Guizhou Medical University	Institutional study system	De-identified case-report data collection and management
Gabapentin	Hospital pharmacy	Not applicable	Physician-prescribed neuropathic-pain treatment
Mobile follow-up platform	Institutional study system	Study-specific mobile follow-up interface	Daily symptom entry and rule-based alert generation
Morisky Medication Adherence Scale (MMAS-8)	Donald E. Morisky / authorized licensor	Not applicable	Medication-adherence assessment using the 8-item Morisky Medication Adherence Scale
Numeric Rating Scale (NRS)	Not applicable	Not applicable	0–10 verbal/numeric scale; Pain-intensity assessment
Pregabalin	Hospital pharmacy	Not applicable	Physician-prescribed neuropathic-pain treatment
Pittsburgh Sleep Quality Index (PSQI)	University of Pittsburgh / authorized source	Standard PSQI instrument	Sleep-quality assessment at baseline and Weeks 4 and 8
R software	R Foundation for Statistical Computing	Version 4.3.2; https://www.r-project.org/	Statistical modeling
Rescue analgesic(s)	Hospital pharmacy	Not applicable; prescribed as clinically indicated	Short-course rescue treatment prescribed as clinically indicated
SPSS Statistics	IBM Corp.	Version 27.0; https://www.ibm.com/products/spss-statistics	Statistical analysis
Structured Nursing Symptom Checklist	Study-developed	Study-specific instrument	Ten-item study-developed symptom-burden assessment
Paper symptom/pain diary	Study-provided	Study-specific paper form	Used after discharge for evening NRS recording and daily sleep/symptom documentation when the mobile platform was not used
Sequentially numbered opaque sealed envelopes	Study team	Not applicable	Used for allocation concealment after eligibility and baseline assessment
Standardized case-report forms (CRFs)	Study-developed	Study-specific	Used by trained research staff for baseline and follow-up data collection; paper forms were double-entered into the electronic database