JMIR research protocols · 2026
Efficacy and Safety of Electroacupuncture for Postoperative Insomnia in Patients With Spinal Metastasis: Protocol of a Prospective, Multicenter, Randomized Controlled Study.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Jiang Cuifang, Yin Mengchen, Peng Xia, Zhao Junqiao, Zhang Fan, Ma Junming, Wang Dong, Cao Yan
Аннотация
BACKGROUND: Postoperative insomnia is one of the common complaints caused by spinal metastatic cancer surgery. It affects patients' functional recovery, greatly reduces their quality of life, and adversely impacts disease prognosis. Compared with traditional pharmacological treatments, acupuncture is an alternative therapy for postoperative insomnia. However, standardized, high-quality randomized controlled trials on electroacupuncture for postoperative insomnia in patients with spinal metastasis (SM) are scarce, and there is a lack of clear inclusion criteria for this specific population. Postoperative insomnia in patients with SM has distinct clinical characteristics compared with general cancer-related insomnia, necessitating targeted investigation.
OBJECTIVE: This study aims to evaluate the efficacy and safety of electroacupuncture in the treatment of postoperative insomnia in patients with SM, and to provide high-level clinical evidence for the inclusion of electroacupuncture in the clinical management plan of postoperative insomnia in patients with SM.
METHODS: This is a study protocol for a randomized controlled trial. We will randomly assign 196 patients with insomnia after spinal metastatic cancer surgery to the acupuncture group (n=98) or the control group (sham acupuncture group; n=98). All participants will be treated on the first day after surgery and receive 12 sessions in total (30 min per session, 3 sessions per wk for 4 weeks). The primary outcome is the change in Pittsburgh Sleep Quality Index score from baseline to post treatment (wk 4). The secondary outcomes include actigraphy records (sleep efficiency, number of sleep awakenings, total sleep time, sleep latency, and wake after sleep onset), Insomnia Severity Index, Spine Oncology Study Group Outcomes Questionnaire 2.0, and Patient Health Questionnaire-9. All results will adhere to the intention-to-treat principle and will be evaluated at baseline, posttreatment (wk 4), and follow-up (wk 12).
RESULTS: This study was funded in June 2023 (supported by the Project of Shanghai Municipal Health Commission, National Natural Science Foundation of China, etc). Recruitment will start in mid-2026 and end in December 2027. Data collection will be completed in October 2027, and data analysis is expected to be finished in December 2027. The results of this study are anticipated to be published in the first half of 2028.
CONCLUSIONS: This study is designed to rigorously assess the therapeutic value of electroacupuncture for postoperative insomnia in patients with SM. If proven effective, electroacupuncture is expected to become a safe and feasible alternative or complementary therapy for this population, reducing reliance on hypnotic drugs and improving patients' quality of life and prognosis. The results will fill the gap in current clinical evidence for electroacupuncture in the treatment of spinal metastatic postoperative insomnia and provide a basis for the optimization of clinical treatment strategies.
OBJECTIVE: This study aims to evaluate the efficacy and safety of electroacupuncture in the treatment of postoperative insomnia in patients with SM, and to provide high-level clinical evidence for the inclusion of electroacupuncture in the clinical management plan of postoperative insomnia in patients with SM.
METHODS: This is a study protocol for a randomized controlled trial. We will randomly assign 196 patients with insomnia after spinal metastatic cancer surgery to the acupuncture group (n=98) or the control group (sham acupuncture group; n=98). All participants will be treated on the first day after surgery and receive 12 sessions in total (30 min per session, 3 sessions per wk for 4 weeks). The primary outcome is the change in Pittsburgh Sleep Quality Index score from baseline to post treatment (wk 4). The secondary outcomes include actigraphy records (sleep efficiency, number of sleep awakenings, total sleep time, sleep latency, and wake after sleep onset), Insomnia Severity Index, Spine Oncology Study Group Outcomes Questionnaire 2.0, and Patient Health Questionnaire-9. All results will adhere to the intention-to-treat principle and will be evaluated at baseline, posttreatment (wk 4), and follow-up (wk 12).
RESULTS: This study was funded in June 2023 (supported by the Project of Shanghai Municipal Health Commission, National Natural Science Foundation of China, etc). Recruitment will start in mid-2026 and end in December 2027. Data collection will be completed in October 2027, and data analysis is expected to be finished in December 2027. The results of this study are anticipated to be published in the first half of 2028.
CONCLUSIONS: This study is designed to rigorously assess the therapeutic value of electroacupuncture for postoperative insomnia in patients with SM. If proven effective, electroacupuncture is expected to become a safe and feasible alternative or complementary therapy for this population, reducing reliance on hypnotic drugs and improving patients' quality of life and prognosis. The results will fill the gap in current clinical evidence for electroacupuncture in the treatment of spinal metastatic postoperative insomnia and provide a basis for the optimization of clinical treatment strategies.