An interventional study of TENStem eco basic and TENStem eco basic in Thyroid Surgery, Electrical Stimulation and Thyroid Carcinoma, sponsored by Xiaonan Huang. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Xiaonan Huang · Not applicable, Interventional, and Supportive care
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.
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.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 668 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Xiaonan Huang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Be over 18 years of age;
Neck or thyroid surgery within the past ten years;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: TENStem eco basic
Device: TENStem eco basic
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.
Also known as: Experimental Arm
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)30 minutes of ineffective microcurrent stimulation.
Also known as: Placebo
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
Time frame: 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
PONV classification
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.
Time frame: Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours
40-item Quality of Recovery (QoR-40) score
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.
Time frame: Postoperative 24 hours
Pain-related measures
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.
Time frame: 8.00 am on the morning after the operation
Safety indicators
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.
Time frame: Postoperative 24 hours
Plan to share: Yes — Only IPD used in the results publication.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Xiaonan Huang