Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 24, 2025
Date Accepted: Oct 16, 2025
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Effects of shallow needling for chronic primary insomnia: A study protocol for a randomized controlled trial
ABSTRACT
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:
Subject recruitment is currently underway. The first participant was enrolled in August 2023, marking the official start of the experiment. As of the submission of this paper, a total of 120 subjects have participated in this clinical trial. The recruitment is expected to continue until August 2025, at which point the data processing and analysis will commence.
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: ITMCTR2024000409. Registered on 30 August 2024, Version 1.0.
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