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Acupuncture for Comorbid Chronic Nonspecific Neck Pain and Chronic Insomnia: Protocol for a Multicenter, Randomized,
Sixing Liu1, He Chen2, Xinyu Shen2,3
1School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Background:
Chronic nonspecific neck pain (CNSNP) and chronic insomnia frequently coexist and may reinforce one another, yet high-quality evidence for nonpharmacological interventions targeting both conditions remains limited. This protocol describes a multicenter randomized trial evaluating the efficacy and safety of acupuncture for this clinically important comorbidity.
Methods:
This multicenter, parallel-group, participant-, assessor-, and statistician-blinded, sham-controlled superiority trial will be conducted at six centers in China. A total of 128 eligible adults aged 18-75 years with comorbid CNSNP and chronic insomnia will be randomly assigned in a 1:1 ratio to receive acupuncture or sham acupuncture. Participants will receive 12 treatment sessions over 4 weeks, followed by 12 weeks of post-treatment follow-up. The co-primary outcomes are the changes from baseline in average neck pain intensity measured by the Numerical Rating Scale (AP-NRS) and in insomnia severity measured by the Insomnia Severity Index (ISI) at week 4. Secondary outcomes include AP-NRS and ISI at other time points, and clinically important pain and sleep response rates, Neck Disability Index, maximum neck pain during neck movement, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, and medication use. Adverse events will also be assessed. Analyses will follow the intention-to-treat principle using mixed-effects models, and the co-primary outcomes will be tested with a fixed-sequence strategy to control the family-wise type I error rate.
Discussion:
This trial addresses an important evidence gap in the management of comorbid CNSNP and chronic insomnia. Its multicenter design, standardized acupuncture procedures, sham comparator, formal blinding assessment, and validated patient-reported outcomes may improve internal validity, clinical interpretability, and generalizability.
Ethics And Dissemination:
The protocol has been approved by the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (Approval No. 2025-090-KY). Written informed consent will be obtained from all participants before enrollment. Findings will be disseminated through peer-reviewed publications and academic presentations.
Trial Registration:
ClinicalTrials.gov NCT06996210; registered on May 30, 2025.
