Dose-effect relationship of different acupuncture courses on chronic insomnia disorder: study protocol for a randomized controlled trial

Abstract

Background: Chronic insomnia disorder (CID) is increasing in prevalence year by year, is long lasting, and potentially risky. Acupuncture has been widely used in the clinical management of this condition. However, there is still a lack of direct evidence on the dose-effect relationship between different acupuncture courses and clinical efficacy. To identify this relationship, we will design a randomized controlled trial to clarify the difference in efficacy of different acupuncture courses for CID.

Methods and design: This is a prospective, parallel, single center randomized controlled trial. Two hundred and one participants with CID will be randomly divided into three groups (Group A, Group B, and Group C). The three groups will be given acupuncture therapy for 4, 6, and 8 weeks, three sessions per week, with at least 1 day between sessions. Follow-up will continue until the third month after the end of treatment. The primary outcome is the Insomnia Severity Index (ISI), and secondary outcomes include percentage of ISI < 8 points, the Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Fatigue Severity Scale (FSS), medication use, and safety.

Discussion: This study is expected to provide direct evidence for the optimal treatment cycle of acupuncture for CID, as well as to facilitate health economic evaluation.

Clinical trial registration: https://clinicaltrials.gov/, identifier [ChiCTR2300073711].

Keywords: acupuncture; chronic insomnia disorder; dose-effect relationship; protocol; randomized controlled trial.

Figure 1

The flowchart of trial procedures.

Figure 2

① Baihui (GV20): 5 cun superior to the anterior hairline, on the anterior midline of the head. ② Yintang (GV29): At the midpoint between the medial ends of eyebrows. ③ Anmian (EX-HN22): at the midpoint between Fengchi (GB20) and Yifeng (SJ17). ④ Shenmen (HT7): On the palmar ulnar end of the transverse crease of the wrist, and on the radial aspect of the tendon of the ulnar flexor m. of the wrist. ⑤ Neiguan (PC6): 2 cun above the transverse crease of the wrist, between the tendons of m. palmaris longus and m. flexor carpi radials. ⑥ Sanyinjiao (SP6): Posterior to the mesial border of the tibia and 3 cun above the tip of the medial malleolus.