The Application of Electrical Stimulation in Postoperative Pain Management of Thyroid Surgery

NCT06931743 | Enrolling By Invitation

• 1 other identifier: CHEC2025-074
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Surgery; Electrical Stimulation; Thyroid Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• PONV classification

  Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours

• 40-item Quality of Recovery (QoR-40) score

  Postoperative 24 hours

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Device: CMNS6-1 Electronic Acupuncture Therapeutic Apparatus

CMNS6-1 Electronic Acupuncture Therapeutic Apparatus

EXPERIMENTAL

CMNS6-1 Electronic Acupuncture Therapeutic Apparatus

Device: CMNS6-1 Electronic Acupuncture Therapeutic Apparatus

Interventions

CMNS6-1 Electronic Acupuncture Therapeutic Apparatus DEVICE

1. The time selection of acupoint treatment is to return to the ward immediately,2 and 4 hours after surgery; 2. Time of each stimulation: 30min; 3. Acupoint extraction: According to the theory of wrist and ankle acupuncture and the location of pain, the upper 1 area (the ulnar margin on the little finger side and the depression of the flexor carpi ulnaris tendon) and the upper 2 area (between the palmaris longus tendon and the flexor carpi radialis on both sides) on the affected side (bilateral for total thyroidectomy) were selected as the intervention site, and the upper and lower parallel electrodes were placed in each area, and a total of 4 electrodes (8 electrodes on both sides) were placed. 4. The parameter setting of the equipment: the frequency is set to 2Hz, the pulse width is set to 500μs, continuous wave is used, and the current intensity is the maximum tolerance of the subject's small pain threshold for 30min.

Also known as: Experimental Arm

CMNS6-1 Electronic Acupuncture Therapeutic Apparatus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaonan Huang: lead

Study Sites (1)

Wrist and Ankle Electrical Stimulation Analgesia Therapy Device

Shanghai, Yangpu District, 200000, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 17, 2025
• Study Start: April 30, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)