Effects of Shallow Needling for Chronic Primary Insomnia: Protocol for a Randomized Controlled Trial.

Background: Primary insomnia (PI), commonly identified by difficulties in initiating and maintaining sleep, negatively impacts both physical and mental health and increases the risk of occupational and vehicular accidents. Previous research has indicated that shallow needling, a form of acupuncture, may ameliorate the symptoms of PI. Nevertheless, the scientific evidence regarding its efficacy in enhancing sleep quality remains limited. Objective: This trial aims to assess the therapeutic efficacy of shallow needling in the treatment of chronic PI in adults. Methods: A single-center, prospective, assessor-blinded randomized controlled clinical trial retrospectively registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR2024000409). With 2 parallel arms, the trial will be conducted at the Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine. A total of 124 participants with PI will be randomly divided into the control group and the treatment group in a ratio of 1:1 (n=62 for each group). The control group will receive 1 mg eszopiclone orally, once a day for 4 weeks. In addition to taking eszopiclone, the treatment group will receive shallow needling therapy once daily, 5 times a week, for 4 weeks. Data will be collected at 3 time slots-before treatment, after treatment, and 4 weeks after treatment-and will be analyzed using SPSS (version 23.0). The primary outcome measure is the Pittsburgh Sleep Quality Index. The secondary outcome measures include the Hamilton Anxiety Scale, Insomnia Severity Index, serum neurotransmitter detection (including dopamine, norepinephrine, and melatonin), sleep parameters, and magnetic resonance spectroscopy of the thalamus. Results: Participant recruitment for this study is currently in progress. The first participant was enrolled in August 2023, marking the official commencement of the trial. Following the completion of recruitment, data processing and statistical analysis will be initiated. The final results of this study are expected to be prepared and submitted for publication in January 2026. Conclusions: This study will evaluate the therapeutic effectiveness and safety of shallow needling in the treatment of chronic insomnia to provide the necessary scientific basis for the clinical application and promotion of shallow needling. The findings of this study may provide a scientific and standardized treatment protocol for shallow needling in adults with chronic insomnia.