Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Project Research Objectives:
Project Research Contents:
1. Parameter Setting and Evaluation of the Wrist-Ankle Electrical Stimulation Analgesia Device
2. Formulation and Optimization of Analgesic Schemes
3. Clinical Application of the Wrist-Ankle Electrical Stimulation Analgesia Device
4. Data Analysis and Mechanism Exploration
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator |
| |
| CMNS6-1 Electronic Acupuncture Therapeutic Apparatus | Experimental | CMNS6-1 Electronic Acupuncture Therapeutic Apparatus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMNS6-1 Electronic Acupuncture Therapeutic Apparatus | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain VAS score | VAS (Visual Analogue Scale) scoring, namely visual analogue scoring, usually employs a straight line or ruler 10 centimeters long, with0 representing the "no pain end" and 10 representing the "most intense pain". The patient marks on the straight line according to the level of pain he or she, to indicate the intensity of pain and the degree of unpleasant psychological experience. The higher the VAS score, the more painful it is. 0 points: no pain; -3 points: mild pain; 4-6 points: moderate pain; 7-9 severe pain; 10 points: unbearable pain, namely severe pain | 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 |
| Pain-related measures | Pain-related indicators: Comparison of blood-related indicators between the control group and the intervention group of patients before and 3 hours after surgery, such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and interleukin (ILs). | Preoperative and Postoperative 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PONV classification | The PONV score is a tool used to assess the severity of postoperative nausea and vomiting (PONV). The higher the PONV score, the severe the condition (1-4 mild, 5-6 moderate, 7-10 severe). | Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours |
| 40-item Quality of Recovery (QoR-40) score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wrist and Ankle Electrical Stimulation Analgesia Therapy Device | Shanghai | Yangpu District | 200000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| CMNS6-1 Electronic Acupuncture Therapeutic Apparatus | Device |
(4)30 minutes of ineffective microcurrent stimulation. |
|
|
The QoR-40 instrument is a tool used to assess a patient's quality of recovery after surgery. In this instrument, a higher score usually means better quality of recovery. |
| Postoperative 24 hours |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
Not provided
Not provided