This will be a 16-week prospective, multicenter RCT carried out at 4 clinical institutions, including (1) Longhua Hospital, Shanghai University of Traditional Chinese Medicine; (2) Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine; (3) Hangzhou TCM Hospital, Zhejiang Chinese Medical University; (4) Shanghai Tonghe Orthopedic Hospital; and (5) Department of Spine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai (200437), China.

The 16-week study period (4-wk treatment+8 wk follow-up) is determined based on the characteristics of postoperative recovery and the therapeutic cycle of electroacupuncture. The postoperative recovery of patients with SM is a long process, and sleep disturbance may persist for several months. A 4-week treatment cycle is consistent with the conventional course of acupuncture for insomnia, facilitating the observation of immediate therapeutic effects [26]. The 8-week follow-up period can further evaluate the sustainability of the therapeutic effect and whether insomnia symptoms rebound, which is of great significance for guiding long-term clinical management. Previous studies have shown that the therapeutic effect of electroacupuncture on insomnia can be maintained for 1‐3 months after treatment, so an 8-week follow-up is set to fully observe the long-term effect [27,28].

The schedule of treatment assessments and data collection is presented in Table 1. The trial protocol was developed in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines, and the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to ensure methodological rigor and transparency of the intervention reporting [29,30]. There is a deviation in recruitment timeline. The initial recruitment start date recorded in the trial registry was May 2025. Owing to logistical preparation and multicenter institutional coordination for the study, the recruitment timeline has been revised and the confirmed start date is March 2026, which is the actual operational schedule for this trial.

The study will include 196 patients with insomnia. We will recruit patients through offline promotion and the hospitals’ official information platforms. Researchers will maintain contact with interested patients and conduct face-to-face interviews to gain a deeper understanding of their characteristics and specific situations. To enroll in the trial, participants need to be informed of the benefits and adverse reactions of this trial after being screened by the researchers in accordance with the inclusion and exclusion criteria. Participants have the right to withdraw from the study at any time.

The sample size was estimated based on anticipated changes in PSQI scores. Based on previous trials among populations with CRI, the mean difference of PSQI between 2 groups is assumed to be 1.8 (SD 3.9) for both groups [28]. Through Power Analysis and Sample Size system (version 15.0.5) calculation, a sample size can provide 90% power to reject the null hypothesis with a significance level of 0.05 using a 2-sided 2-sample t test assuming equal variance. Considering the expected dropout rate of 20%, the final sample size is 196, with 98 patients in each group.

The random allocation scheme for this trial will be generated by The Clinical Research Center of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine. We will use stratified block randomization with centers as a stratification factor for group inclusion. When blocks are used up, centers will inform the data management center for replenishment. Independent investigators will place the treatment assignment code in consecutively numbered opaque envelopes based on the order of patients’ visits. All participants will be informed that they have the same probability of being assigned to the electroacupuncture group or the sham electroacupuncture group. Participants and researchers will not know the grouping in advance. To ensure the reliability of the research, all researchers will strictly abide by the principle of departmental separation and receive standardized training before implementation.

This study adopts a single-blind (patient-assessor–blinded) method. Except for the acupuncturists, other personnel, including all participants, outcome assessors, data analysts, and statisticians, will be blinded to the patients’ grouping. To reduce communication and contact between patients, we will assign patients to receive treatment in different rooms. During the entire treatment period, patients should wear eye patches. Blind evaluation will be used by the evaluator to assess and record various observation indicators. To ensure the safety of the study data, we will set up a data safety monitoring committee in accordance with the guidance of the Data Safety Monitoring Board (DSMB). The data will ultimately be summarized by third-party blind statistical analysis.

All study participants will be randomly assigned to either the electroacupuncture group or the sham electroacupuncture group in a 1:1 ratio, receiving treatment 3 times per week for 4 weeks. At the same time, we will keep records of actigraphy for patients at week 0, week 1, week 2, week 3, and week 4. Allocation of participants will be conducted by a licensed acupuncturist with more than 2 years of clinical experience. Except for the acupuncturists, the study investigators, participants, outcome assessors, study staff, and statisticians will all be blinded to the allocation. Before treatment, we will perform skin sterilization for patients. If patients experience severe physical discomfort due to insomnia, we will prescribe appropriate medication based on their conditions. During the medication period, we will strictly record the name, dosage, and administration method. Relevant investigators will also record the medication taken by patients on a CRF.

Patients in the electroacupuncture group will receive electroacupuncture performed by acupuncturists. Stainless steel 0.25×40 mm acupuncture needles (Suzhou Yan yi Medical Technology Co, Ltd) will be inserted into 6 acupoints, including Bai Hui (GV20), Shen Ting (GV24), Yin Tang (GV29), An Mian (EX-HN22), Shen Men (HT7), and Nei Guan (PC6) acupoints (Figure 1; for acupoint location, refer to The Location of Acupoints: State Standard of the People’s Republic of China [GB/T 12346‐2021] [33]). The locations, indications, and manipulation methods are specifically presented in Table 2. After the needle is inserted to a certain depth of the points, the acupuncturist will lift and thrust or rotate the needles to induce Deqi sensation. According to Traditional Chinese Medicine, there are 6 clinical manifestations of Deqi sensations, that are pain, numbness, distension, heaviness, dispersion, and dull pain [34,35]. After Deqi, the electroacupuncture device (CMNS6-1 [Wuxi Jia jian Medical Device Co, Ltd, China]) will be applied, connecting to points Bai Hui (GV20) and Yin Tang (GV29) with a frequency of 3 Hz, and the amplitude will vary depending on the patient’s comfort, limited between 2 and 5 mA to strengthen the needling sensation. The needle retention time is 30 minutes per session, as reported according to STRICTA guidelines.

Patients in the sham electroacupuncture group will receive the sham electroacupuncture intervention treatment at the same acupoints as the treatment group. We will use the placebo needle named Streitberger placebo needle from Germany in this study [36]. It is blunt without a sharp tip and cannot penetrate the skin. This kind of needle can move inside the handle and appear to be shortened after puncturing without penetrating the skin. Therefore, it is difficult for patients to distinguish between sham acupuncture and real acupuncture. The electroacupuncture device will be connected to points Bai Hui (GV20) and Yin Tang (GV29) without any electrical current.

AEs related to electroacupuncture during this trial will be recorded in detail. A study provided information on AEs related to treatment, finding that AEs are all mild, including skin allergic reactions, hematomas, local pain, nausea, dizziness, and headache [44]. These AE data will be assessed in terms of severity and causality, and the incidence will also be determined. A 3-point grading system will be applied—grade 1 (mild), grade 2 (moderate), grade 3 (severe or medically significant). They will be recorded in the AEs form for further investigation by researchers who will analyze the causes of these events. The causality categories used will be certain, probable or likely, possible, unlikely, conditional or unclassified, and unassessable or unclassifiable. Serious AEs should be reported to the principal investigator (YC and MY) and Ethics Committee within 24 hours of occurrence.

The Credibility Assessment Questionnaire is applied to assess the reliability and credibility of the trial, including the selection of the control group, the implementation of the blinding method, and the details of electroacupuncture treatment. The Credibility Assessment Questionnaire is used in electroacupuncture trials to improve the accuracy and repeatability of the trials. We will ask participants in this trial to rate the following questions on a 6-point scale: (1) How confident are you that this treatment can alleviate your complaints?; (2) If your friends also have similar complaints, how confident would you be in recommending this treatment method to them?; (3) How logical do you think this treatment is?; and (4) How successful do you think this treatment is in reducing other complaints? [45].

After participants receive treatment, we expect that patients in the treatment group will have a significant improvement in sleep complaints compared with those in the sham electroacupuncture group, which will be reflected in the changes in outcome measurements. Electroacupuncture has shown certain positive effects on postoperative insomnia in patients with spinal cancer. It can be part of a comprehensive treatment plan in conjunction with other medications or nonpharmacological treatments to enhance therapeutic effects. All treatments should be carried out within a safe range to ensure the safety of electroacupuncture.

We will establish an independent DSMB to monitor whether the study design meets guideline standards to ensure the rigor of the trial. The committee consists of 5 members from different fields. Members of the DSMB must declare that there are no conflicts of interest to ensure the independence of their decisions. The DSMB will periodically review the accumulated data from clinical trials, assess the risks and benefits during the trial process, and ensure the safety of the patients. Based on the review of the data, the DSMB can advise the researchers to continue, modify, or suspend the trial. If serious AEs occur, they have the right to suspend or terminate the trial.

All statistical analyses will be performed using SPSS 26.0 (IBM Corp) or R 4.2.0 software (R Core Team). The 2-sided significance level will be set at α=.05, and no adjustment for multiple comparisons will be made for secondary outcomes to avoid type II errors, but the results will be interpreted with caution.

This study is designed to test the hypothesis that compared with the sham electroacupuncture group, the electroacupuncture group will show a significant reduction in PSQI score from baseline to posttreatment (wk 4), indicating improved sleep quality. Based on previous evidence, electroacupuncture is expected to perform better in objective sleep indicators (such as increased sleep efficiency, prolonged TST, reduced number of sleep awakenings, shortened SOL, and decreased WASO), have a lower ISI score (reduced severity of insomnia), an improved SOSGOQ 2.0 score (enhanced quality of life), and a lower PHQ-9 score (alleviated depressive symptoms). In addition, electroacupuncture is expected to have a low incidence of AEs, demonstrating good safety.

Existing studies have confirmed the efficacy of electroacupuncture in the treatment of general insomnia and CRI. For example, a multicenter RCT by Lee et al [28] found that electroacupuncture can improve the sleep quality of patients with CRI. However, these studies did not specifically target patients with postoperative SM, who have unique clinical characteristics such as postoperative pain, spinal instability, and neurological damage. Patients with SM often have more complex sleep disturbance mechanisms, and the efficacy of electroacupuncture may differ from that in other populations.

In addition, most previous studies used small sample sizes and single-center designs, resulting in limited generalizability of the results. This study adopts a multicenter design, recruits 196 participants, and uses strict randomization, allocation concealment, and blinding methods to reduce bias, which is expected to provide more reliable clinical evidence. The selection of acupoints in this study is based on Traditional Chinese Medicine theory and clinical practice, and the treatment parameters (frequency, current intensity, and needle retention time) are standardized in accordance with STRICTA guidelines, facilitating the replication of the study results.

There has been extensive debate in the acupuncture research field regarding whether sham needling should be performed at true acupoints or nonacupoints. Proponents of nonacupoint sham needling argue that it can better control for the nonspecific effects of needle insertion, while advocates of true acupoint sham needling emphasize that the anatomical and physiological characteristics of acupoints may affect the blinding effect. In this study, we chose to use the Streitberger placebo needle at the same acupoints as the treatment group, and this choice is justified for the following reasons:

First, it ensures the success of blinding. The Streitberger placebo needle has a blunt tip that cannot penetrate the skin, but it can move within the handle, creating the illusion of needle insertion. For patients with postoperative SM who may have limited knowledge of acupuncture, this design makes it difficult to distinguish between real and sham acupuncture. If nonacupoints were used, the different anatomical locations might lead to differences in skin sensation, increasing the risk of unblinding.

Second, it controls for acupoint-specific effects. By using the same acupoints in both groups, the only difference between the electroacupuncture group and the sham electroacupuncture group is the presence or absence of effective needling (penetration and electrical stimulation), which can accurately evaluate the specific therapeutic effect of electroacupuncture. Previous studies have shown that true acupoint sham needling with placebo needles is an effective control method in acupuncture RCTs, as it can minimize the impact of nonspecific effects, such as expectation and attention [46,47].

Third, it is consistent with the clinical scenario. The acupoints selected in this study are commonly used in the clinical treatment of insomnia. Using the same acupoints for sham treatment ensures that the treatment process is similar to clinical practice, improving the external validity of the study. A systematic review by Xie et al [36] confirmed the validity of the Streitberger placebo needle in Chinese populations, further supporting the appropriateness of our choice. Therefore, the chosen sham electroacupuncture design is methodologically appropriate and consistent with contemporary recommendations for acupuncture RCTs.

This study has several strengths, such as (1) targeted population: focusing on patients with insomnia after SM surgery, a special population with unmet clinical needs, filling the gap in existing research; (2) rigorous study design: adopting a prospective, multicenter RCT design, with strict randomization, allocation concealment, and single-blind methods to ensure the internal validity of the study; (3) comprehensive outcome indicators: combining subjective (PSQI, ISI, etc) and objective (actigraphy) indicators to comprehensively evaluate sleep quality, and simultaneously assessing quality of life and depressive symptoms to reflect the overall therapeutic effect; (4) standardized intervention: the acupoint selection, manipulation methods, and treatment parameters of electroacupuncture are standardized in accordance with STRICTA guidelines, and acupuncturists are trained uniformly to ensure the consistency of treatment; (5) complete SAP: in accordance with SPIRIT guidelines, a detailed SAP is provided, including analysis methods for primary and secondary outcomes, additional analyses, and handling of missing data; and (6) complete safety monitoring: establishing a DSMB to monitor the study process, and recording AEs in detail to ensure the safety of participants.

Despite the rigorous design, this study still has some limitations. First, blinding limitations: although Streitberger placebo needles are used for the sham electroacupuncture group, acupuncturists are aware of the grouping, which may lead to performance bias. However, we have taken measures, such as separate treatment rooms and eye masks for patients to minimize this bias. Second, follow-up period: the follow-up period of this study is 8 weeks, which may not be sufficient to evaluate the long-term efficacy of electroacupuncture. Future studies can extend the follow-up period to observe the sustainability of the therapeutic effect. Third, lack of mechanism exploration: this study focuses on clinical efficacy and safety, and does not explore the underlying mechanism of electroacupuncture in improving sleep. Future studies can combine biological indicators (such as neurotransmitters and cytokines) to explore the mechanism. Fourth, exclusion criteria limitations: the study excludes patients with severe comorbidities, mental disorders, and chronic insomnia disorder, which may limit the generalizability of the results to the entire population with postoperative SM. Fifth, potential confounding factors: although we have adjusted for common confounding factors in the statistical analysis, there may still be unmeasured confounding factors (such as postoperative pain intensity and family support) that affect the study results. Finally, single-blind design: due to the characteristics of acupuncture treatment, it is difficult to implement double-blinding (acupuncturists cannot be blinded). This may introduce potential bias, but single-blinding of patients and outcome assessors can still reduce the impact of subjective factors.

If the efficacy of electroacupuncture is confirmed in this study, future research can be carried out in the following directions: (1) optimize the treatment plan: explore the optimal acupoint combination, treatment frequency, and course of electroacupuncture for SM postoperative insomnia to further improve the therapeutic effect; (2) mechanism research: explore the mechanism of electroacupuncture in improving SM postoperative insomnia from the perspectives of neuroendocrinology, immunology, and circadian rhythm; (3) combined therapy: study the efficacy of electroacupuncture combined with other nonpharmacological therapies (such as cognitive behavioral therapy for insomnia and music therapy) in the treatment of SM postoperative insomnia; (4) expand the population: conduct studies in patients with SM with different tumor types, surgical methods, and disease stages to further verify the generalizability of the results; (5) long-term follow-up: extend the follow-up period to 6‐12 months to evaluate the long-term efficacy and safety of electroacupuncture; (6) individualized treatment: based on patient characteristics (such as age, gender, and tumor type), develop individualized electroacupuncture treatment plans to improve the precision of treatment.

The results of this study will be disseminated through multiple channels. First, academic conferences present the study results at domestic and international conferences on Traditional Chinese Medicine, oncology, and sleep medicine to exchange with peers. Second, academic journals publish the study results in high-quality peer-reviewed journals to provide evidence for clinical practice guidelines. Third, clinical promotions popularize the effective treatment plan among clinical doctors in relevant fields (such as orthopedics, oncology, rehabilitation, and Traditional Chinese Medicine) through training courses, workshops, etc, to benefit more patients with insomnia after SM surgery. Fourth, by public education, the research results are disseminated to the public through hospital official websites, WeChat (Tencent Holdings Limited) public accounts, and other platforms to improve the awareness of nonpharmacological therapies for insomnia. Finally, by providing policy recommendations to health administrative departments based on the study results, promoting the inclusion of electroacupuncture in the clinical management guidelines for SM postoperative insomnia.

This study will fill the methodological deficiencies of current clinical trials on acupuncture for the treatment of insomnia after SM surgery and provide a promising therapeutic intervention for clinical patients with insomnia after SM surgery.