The evaluation of the clinical effect of primary insomnia treated with the manual acupuncture therapy: a study protocol for a parallel, randomized controlled trial

Abstract Background Clinically, primary insomnia (PI) manifests as difficulty falling asleep, difficulty maintaining sleep, or early waking up. The occurrence of PI is closely related to emotional disorders, social stress and environmental stress. According to current studies, acupuncture offers significant advantages in treating PI. The manual acupuncture has been used for the treatment of insomnia for decades. Different acupuncture strategies, including electroacupuncture, manual acupuncture, and multiple acupuncture, have been reported to treat insomnia. However, there are few standardized clinical reports to investigate the effect of the manual acupuncture and its mechanism. Methods This study was a parallel, randomized controlled trial designed to investigate the clinical efficacy of the manual acupuncture in treating PI, and to clarify the mechanism. The study included a 4-week treatment period and a 4-week follow-up period. All eligible 74 patients diagnosed with PI will be evaluated using scales before treatment, and then be randomly assigned to the acupuncture group and the placebo acupuncture group at a ratio of 1:1. Both groups choose the same acupoints. The patients will be evaluated at 4 weeks before treatment, after 4 weeks of treatment and 4 weeks after treatment respectively. The patients in the acupuncture group were treated with manual acupuncture and placebo acupuncture group received the tube of Park sham devices. All 12 sessions of treatment will last over 4 weeks (3 sessions per week). The main outcome measure will be the change in Pittsburgh sleep quality index before and after treatment, and the secondary outcome measures include Chalder-14 fatigue scale, Epworth sleepiness scale, self-rating depression scale, self-rating anxiety scale, polysomnography and heart rate variability. Discussion This study will evaluate the efficacy and safety of the manual acupuncture, and the results will provide a scientific theoretical basis for the clinical promotion. Trail registration ClinicalTrails.gov Identifier: NCT05830887 . Registered 23 March 2023.