Acupuncture for Comorbid Chronic Nonspecific Neck Pain and Chronic Insomnia: Protocol for a Multicenter, Randomized, Sham-Controlled Trial.

Researchers in China are launching a major study to test whether acupuncture can help people suffering from both chronic neck pain and chronic insomnia at the same time. These two conditions often occur together and can make each other worse, creating a difficult cycle for patients. The study will involve 128 adults aged 18-75 at six medical centers across China. Participants will be randomly assigned to receive either real acupuncture or sham (fake) acupuncture, with neither the patients nor the researchers knowing who gets which treatment. Everyone will receive 12 treatment sessions over four weeks, then be monitored for another 12 weeks afterward. The researchers will measure changes in neck pain using a standard pain scale and improvements in sleep using an insomnia severity questionnaire. They'll also track disability levels, anxiety, depression, and whether patients need less pain or sleep medication. This is a protocol paper, meaning the study is just beginning and results aren't available yet. However, it's an important study because high-quality research on non-drug treatments for people dealing with both conditions simultaneously has been limited. The study uses rigorous scientific methods including proper blinding, validated questionnaires, and a sham control group to ensure reliable results. If successful, this research could provide strong evidence for using acupuncture to address both neck pain and sleep problems together, offering hope for patients struggling with this common combination of symptoms. If you're considering acupuncture for neck pain or insomnia, seek a licensed acupuncturist certified by your state or national acupuncture board.

This multicenter, sham-controlled RCT protocol evaluates acupuncture efficacy for comorbid chronic nonspecific neck pain (CNSNP) and chronic insomnia, conditions that frequently co-occur and mutually reinforce symptomatology. The trial will randomize 128 adults (18-75 years) across six Chinese centers in a 1:1 ratio to receive acupuncture or sham acupuncture. The intervention consists of 12 sessions over 4 weeks with 12-week follow-up. Co-primary outcomes are change from baseline in average neck pain intensity (NRS) and Insomnia Severity Index (ISI) at week 4. Secondary measures include Neck Disability Index, pain response rates, Pittsburgh Sleep Quality Index, HADS, and medication use. The study employs participant-, assessor-, and statistician-blinding with intention-to-treat analysis using mixed-effects models and fixed-sequence testing to control type I error. This protocol addresses a significant evidence gap in managing this comorbidity with a rigorous methodology. As a protocol paper, no efficacy data are yet available; results will inform evidence-based treatment of this clinically important dual presentation.