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

AuthorsWanqing LinChenlin WangJiajia YeYingling YeMin TangQianqian HuBin Chen
Year2025
VenueJMIR Research Protocols

Background: Primary insomnia (PI), commonly identified by difficulties in initiating and/or maintaining sleep, negatively impacts both physical and mental health and increases the risk of occupational and vehicular accidents. Previous researches have indicated that shallow needling, a form of acupuncture, may ameliorate symptoms of primary insomnia. 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 primary insomnia in adults. Methods: A single-center, prospective, assessor-blinded, and randomized controlled clinical trial with two parallel arms will be conducted in the Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine. A total of 124 participants with primary insomnia will be randomly divided into control group and treatment group in a ratio of 1:1 (n = 62 for each group). The control group will take eszopiclone orally at 1 mg once a day for 4 weeks. In addition to taking eszopiclone, the treatment group will receive shallow needling therapy once daily, five times a week, for 4 weeks. Data will be collected at three timeslots (pre, post, 4-weeks follow-up) and analyzed using SPSS 23.0. The primary outcome measure is Pittsburgh Sleep Quality Index (PSQI), Secondary outcome measures are Hamilton anxiety scale (HAMA), Insomnia Severity Index (ISI), Serum neurotransmitter detection (including the content of dopamine [DA], norepinephrine [NE], and melatonin [MT]), sleep parameters, and Magnetic Resonance Spectroscopy (MRS) of the thalamus. Results: This study has received formal ethical approval (Approval No: IRB 2023-014-02), the first participant was enrolled in August 2023, marking the official commencement of the trial. Participant recruitment for this study is currently in progress. Following the completion of recruitment, data processing and statistical analysis will be initiated. The final results of the 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, so as 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. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2024000409; https://itmctr.ccebtcm.org.cn

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