Clinical trial NCT06931743: The Application of Electrical Stimulation in Postoperative Pain Management of Thyroid Surgery
Official title: Research on the Application of Wrist and Ankle Electrical Stimulation Analgesia Therapy Device in Pain Management After Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Thyroid Surgery
Electrical Stimulation
Thyroid Carcinoma
Lead sponsor: First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the efficacy and safety of the wrist and ankle electrical stimulation analgesia therapy device in the management of analgesia after thyroidectomy by conducting clinical studies to collect data. It will also be combined with the Internet of Things technology to develop artificial intelligence equipment or applications to achieve remote monitoring and intelligent alarm, and improve the timeliness and initiative of pain management after thyroidectomy. In the future, we will further carry out a series of research work to explore the possible analgesic mechanisms through molecular biology and neurophysiology.

Detailed description: Project Research Objectives：

1. Explore Innovative Analgesic Management Schemes after Thyroidectomy Through clinical trials and data analysis, evaluate the efficacy and safety of the wrist-ankle electrical stimulation analgesia device in post-thyroidectomy analgesia management. Explore more scientific, reasonable, and effective postoperative analgesia management schemes to provide theoretical basis and empirical support for clinical practice and promote the development and progress of pain management.
2. Achieve Remote Monitoring and Artificial Intelligence Application In the future, it will be combined with Internet of Things technology to develop artificial intelligence equipment or applications to achieve remote monitoring and intelligent alarm, improving the timeliness and proactiveness of post-thyroidectomy pain management.
3. Explore Related Analgesic Mechanisms The mechanism of the wrist-ankle electrical stimulation analgesia device in post-thyroidectomy analgesia may involve the gate control theory, the release of endogenous analgesic substances, and neural regulation, among others. In the future, we will conduct a series of research works, using molecular biology and neurophysiology methods to deeply explore the possible analgesic mechanisms.

Project Research Contents：

1. Parameter Setting and Evaluation of the Wrist-Ankle Electrical Stimulation Analgesia Device

1. Parameter setting of the wrist-ankle electrical stimulation analgesia device: Adjust the device parameters most suitable for post-thyroidectomy analgesia management and determine the corresponding acupoints, intervention timing, and intervention duration, etc.
2. Safety and effectiveness evaluation: Evaluate the safety and effectiveness of the selected device to ensure that it does not cause additional harm or risk to patients during use and can achieve the expected analgesic effect.

2. Formulation and Optimization of Analgesic Schemes

1. Individualized analgesic schemes: Develop individualized analgesic schemes based on patients' age, gender, weight, surgical scope, pain degree, and other factors.
2. Analgesic effect monitoring: Evaluate the pain degree of patients at different time points after surgery using VAS scores and other scales for quantitative assessment to monitor the analgesic effect.
3. Scheme optimization and adjustment: Adjust the analgesic scheme in a timely manner based on the monitoring results of the analgesic effect, such as adjusting the intervention time and stimulation duration, to achieve the best analgesic effect.

3. Clinical Application of the Wrist-Ankle Electrical Stimulation Analgesia Device

1. Operation training: Provide operation training for medical staff to ensure they can master the usage methods and precautions of the device proficiently.
2. Patient education: Educate patients on postoperative analgesia management, including relevant precautions, possible side effects and countermeasures, etc., to improve patients' compliance and encourage them to actively participate in their own pain management.
3. Observation of clinical application effects: Observe and record the pain degree, comfort level, adverse reactions, etc. of patients during the postoperative analgesia management process using the device, and evaluate its clinical application effect.
4. Remote monitoring and operation: Develop artificial intelligence equipment or mobile application APPs to achieve remote monitoring and operation.

4. Data Analysis and Mechanism Exploration

1. Data collection: Collect patients' pain scores, analgesic drug usage, adverse reaction rates, and preoperative and postoperative psychological evaluation scales, etc.
2. Statistical analysis: Use statistical methods to process and analyze the collected data, compare the effects of different analgesic schemes, and evaluate the effect, safety, and patient satisfaction of the wrist-ankle electrical stimulation analgesia device in post-thyroidectomy analgesia management based on the analysis results.
3. Exploration of analgesic mechanisms: Further explore the possible analgesic mechanisms through molecular biology and neurophysiology methods. For example, use neuroelectrophysiological techniques (such as EEG, EMG, etc.) to study the effects of electrical stimulation on neuronal activity, including changes in excitability, inhibition, and synchronization of neurons. Observe whether the neural activity patterns in pain-related brain regions change under the effect of electrical stimulation and how these changes affect pain perception. It is also possible to study whether electrical stimulation alleviates pain by activating the endogenous analgesic system, such as by releasing endorphins and other analgesic substances.

Eligibility criteria: 1. Inclusion Criteria:

   * Be over 18 years of age;
   * The operation time is less than 4 hours;
   * Postoperative VAS pain score ≥3 points ;
   * Clear consciousness, able to answer questions accurately, free speech, no hearing impairment;
   * Informed consent
2. Exclusion Criteria:

   * Neck or thyroid surgery within the past ten years;
   * Menstruating, pregnant and lactating females;Those who are not satisfied with blood glucose control;
   * Skin injury or allergy; skin ulceration;
   * Past history of psychiatric disorder that met the diagnostic criteria of Diagnostic and Manual of Mental Disorders, DSM-IV;
   * Upper respiratory tract infection within 2 weeks before surgery;
   * History of implantation of pace or defibrillator;
   * Allergic to gel or intolerant to electrical stimulation;
   * History of chronic pain, pain VAS score 1 at the examination;
   * Use of sedative analgesic drugs for a long time or within 24 hours;
   * Particip in other clinical trials in the past 4 weeks.

Primary outcomes:
measure: Pain VAS score
timeFrame: Evaluation time: 1) the subject returned to the ward after surgery; 2) immediately after electrical stimulation; 3) Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours
measure: Pain-related measures
timeFrame: Preoperative and Postoperative 3 hours
Secondary outcomes:
measure: PONV classification
timeFrame: Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours
measure: 40-item Quality of Recovery (QoR-40) score
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Wrist and Ankle Electrical Stimulation Analgesia Therapy Device
state: Yangpu District
Study officials:
References: