Electrical Stimulation, Thyroid Carcinoma, Thyroid Surgery
Conditions
Brief summary
Post-thyroidectomy pain is a prevalent early postoperative complication. While pharmacological agents remain the mainstay of analgesia, their clinical application is constrained by adverse effects including nausea, respiratory depression, and gastrointestinal disturbances. Transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA) is a non-invasive analgesic modality that has demonstrated preliminary benefits in multiple pain scenarios. Nevertheless, robust evidence for its efficacy in post-thyroidectomy pain management is still lacking, limited by single-center designs and small sample sizes in existing studies. This trial aims to evaluate the efficacy and safety of TENS-WAA for pain control after thyroidectomy. The findings are expected to support a standardized non-pharmacological analgesic option as an adjunct to multimodal postoperative pain regimens, aligning with Enhanced Recovery After Surgery (ERAS) principles.
Detailed description
Background Post-thyroidectomy pain is a prevalent early complication stemming from incision trauma, tissue retraction and cervical muscle spasm, which impairs early functional recovery and reduces patient satisfaction. Opioids and non-steroidal anti-inflammatory drugs remain the mainstay of postoperative analgesia, but their clinical value is limited by suboptimal pain control, well-recognized adverse effects (nausea, respiratory depression, constipation, bleeding and renal risks), and marked inter-individual variability in therapeutic response. Aligned with Enhanced Recovery After Surgery (ERAS) principles, multimodal analgesia integrating pharmacological and non-pharmacological strategies is increasingly recommended. However, no standardized non-pharmacological analgesic protocol exists for post-thyroidectomy pain. Transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA) is a non-invasive, self-administrable analgesic approach. Preliminary evidence supports its efficacy across multiple pain conditions, potentially via modulating pain-related brain regions and promoting endogenous opioid release. Current evidence in thyroidectomy populations is limited by single-center designs, small samples and protocol heterogeneity, requiring high-quality multicenter randomized controlled trials for validation. Study Objectives To evaluate the efficacy of TENS-WAA in reducing post-thyroidectomy pain intensity compared with sham stimulation. Study Design This is a prospective, multicentre, randomised, open-label, assessor-blinded, parallel-group superiority controlled trial, conducted across three tertiary hospitals in China. A total of 668 patients scheduled for elective conventional thyroidectomy will be enrolled. Eligible participants will be stratified by surgery type (unilateral thyroidectomy vs. bilateral thyroidectomy), and randomised in a 1:1 ratio to either the active TENS-WAA group or the sham stimulation group via stratified block randomisation. Random allocation will be implemented through a central web-based randomisation system to ensure allocation concealment. Given the perceptible nature of electrical stimulation, participants and intervention administrators will not be blinded to group assignment. However, outcome assessors responsible for pain scoring, data collection and biosample processing, as well as the study statistician, will remain blinded to group allocation throughout the trial. All primary efficacy analyses will follow the intention-to-treat (ITT) principle. The recruitment period is scheduled from May 2025 to December 2026. Intervention Description All participants will receive standard postoperative care in accordance with each institution's routine clinical protocols. The study intervention will be delivered at three postoperative time points: immediately upon returning to the ward, and 2 hours and 4 hours after returning to the ward, with each stimulation session lasting 30 minutes. Primary Outcome Pain intensity measured by the 10-cm Visual Analogue Scale (VAS), where 0 represents "no pain" and 10 represents "the worst pain imaginable". VAS assessments will be conducted at multiple time points: upon awakening from anaesthesia, immediately after each stimulation session, and at 3, 9, 15, and 24 hours after surgery. Longitudinal VAS data will be analysed using generalized estimating equations, adjusted for baseline VAS score, age, sex and surgery type.
Interventions
DEVICECMNS6-1 Electronic Acupuncture Therapeutic Apparatus
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 250μs, continuous wave is used, and the current intensity is the maximum tolerance of the subject's small pain threshold for 30min.
Sponsors
Xiaonan Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS score | Evaluation time: 1) the subject returned to the ward after surgery; 2) immediately after electrical stimulation; 3) Postoperative 2 hours、Postoperative 3 hours、Postoperative 4 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PONV classification | Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours | The PONV score is a tool used to assess the severity of postoperative nausea and vomiting (PONV). This rating system uses a five-point scale ranging from 0 to 4. |
| 40-item Quality of Recovery (QoR-40) score | Postoperative 24 hours | 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. |
| Pain-related measures | 8.00 am on the morning after the operation | Post-operative venous blood samples were collected to measure serum markers, including C-reactive protein (CRP), interleukins (ILs, including IL-6 and IL-8) and cortisol. |
| Safety indicators | Postoperative 24 hours | Record the number of patients requiring additional analgesia, the total dose of medication administered, patients' post-operative vital signs, and any adverse events experienced by patients following use of the therapeutic device. |
Countries
China
Contacts
CONTACTChaoQian Liu
CONTACTJin Du
Outcome results
None listed