Efficacy and safety of Electroacupuncture for postoperative insomnia in patients with spinal metastasis: protocol of a prospective, multi-center, randomized controlled study (Preprint)

BACKGROUND Postoperative insomnia is one of the common complaints causing from the spinal metastatic cancer surgery. Postoperative insomnia affects the functional recovery of patients, greatly reduces the patient's quality of life and adversely affects the prognosis of the disease. Compared to the traditional pharmacological treatment, acupuncture is an alternative treatment for postoperative insomnia. The aim of this study is to evaluate the effect of acupuncture on postoperative insomnia in spinal metastatic cancer and provide medical evidence for clinical treatment. OBJECTIVE The purpose of this study is to evaluate the effect of electroacupuncture treatment in patients with insomnia after SM surgery, and it is expected to serve as a gradual reduction method to reduce or even replace the use of sleep medication in patients with postoperative insomnia. METHODS This is a study protocol for a randomized controlled trial (RCT). We will randomly assign 196 patients with insomnia after spinal metastatic cancer surgery to the acupuncture group (AG)(n=98) or the control group (sham AG) (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 week for 4weeks). The Pittsburgh Sleep Quality Index (PSQI) score will be used as the main outcome. The secondary outcomes will include the records of actigraphy (sleep efficiency, number of sleep awakenings and total sleep time), Insomnia Severity Index (ISI), Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0), Patient Health Questionnaire-9 (PHQ-9) . All results will adhere to the intention-to-treat principle and will be evaluated from baseline, post-treatment and upon follow-up. Discussion: The results of this study protocol will evaluate the efficacy of acupuncture on the postoperative insomnia in spinal metastatic cancer, and it will contribute to providing a feasible clinical intervention for patients with insomnia after spinal metastasis cancer. RESULTS The results of this study protocol will evaluate the efficacy of acupuncture on the postoperative insomnia in spinal metastatic cancer, and it will contribute to providing a feasible clinical intervention for patients with insomnia after spinal metastasis cancer. CONCLUSIONS The purpose of this study is to evaluate the effect of electroacupuncture treatment in patients with insomnia after SM surgery, and it is expected to serve as a gradual reduction method to reduce or even replace the use of sleep medication in patients with postoperative insomnia. First, we design two groups of EA group and sham EA group to identify whether it is real electroacupuncture that plays a role in treating patients with insomnia after SM surgery or it is just be the placebo effect. Second, we will limit the inclusion criteria for each patient. Participants will be recruited from four hospitals. specialist from these hospitals will join this trial, and they will be responsible for introducing this study to eligible patients and recruiting them. By adopting a rigorous randomized controlled study, we will study the effect of electroacupuncture on postoperative insomnia in SM. Patients' sleep quality will be assessed by recording PSQI score. We will use the actigraphy to record relevant date of patients, such as SOL, TST, SE, and time to WASO. What’s more, participants are blinded to the grouping to ensure allocation concealment and reduce bias. At the same time, the standardized acupoints will be selected by referring to the acupuncture literature and the clinical experience of acupuncturists. Finally, this experiment will use objective and subjective results to represent sleep quality and related symptoms, demonstrating the potential efficacy of electroacupuncture treatment in patients with insomnia after SM surgery. We will use PHQ-9 to assess the severity of depressive symptoms of patients. ISI will be used to evaluate the severity of insomnia. And we will use SC-SOSGOQ 2.0 to evaluate HRQOL of patients. These will be used to comprehensively and objectively assess patients’ sleep quality. Compared with sham EA group, treatment of EA group provided an effective alternative or complementary therapy. Electroacupuncture may exert its effects by stimulating the HPA axis, SNS system, circadian rhythm, cytokines, and neurotransmitters, such as IL-1, IL-6, neuropeptide Y, serotonin, melatonin, dopamine, norepinephrine, gamma aminobutyric acid, beta endorphins, which are important targets in the psychological treatment of depression and anxiety.52,53 However, our study also has limitations and potential risks of bias. Therefore, more well-designed, large sample size, multicenter prospective randomized controlled trials are needed to further validate the efficacy of electroacupuncture treatment in postoperative patients with SM, which will reduce the impact of bias, improve the credibility of research, and better guide clinical practice. To ensure the quality control of electroacupuncture treatment, we will standardize the acupoint selection, manipulation, acupuncture equipment, background and clinical experience of the therapists according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).