Thyroid SurgeryNCT06931743
The Application of Electrical Stimulation in Postoperative Pain Management of Thyroid Surgery
A study testing CMNS6-1 Electronic Acupuncture Therapeutic Apparatus in people with Thyroid Surgery and Electrical Stimulation, run by Xiaonan Huang at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery, Electrical Stimulation, Thyroid Carcinoma
- What is being tested?
- CMNS6-1 Electronic Acupuncture Therapeutic Apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 668 participants
- Where
- 3 sitesChina
- Study dates
- 30 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
the Specialised Medical Centre of the Chinese People's Liberation Army Navy
Shanghai, Changning District, 200000
Jin Du, 18009661988, 1352266146@qq.com
- Recruiting
Changzheng Hospital Affiliated to the Naval Medical University
Shanghai, Huangpu District, 200000
Jin Du, 18009661988, 1352266146@qq.com
- Recruiting
Changhai Hospital Affiliated to the Naval Medical University
Shanghai, Yangpu District, 200000
Jin Du, 18009661988, 1352266146@qq.com
About this study
Official title: Transcutaneous Electrical Nerve Stimulation Based on Wrist-Ankle Acupuncture Theory for Postoperative Pain After Thyroid Surgery: A Multicenter Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Thyroid Surgery, Electrical Stimulation, Thyroid Carcinoma
- Being tested
- CMNS6-1 Electronic Acupuncture Therapeutic Apparatus
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMNS6-1 Electronic Acupuncture Therapeutic ApparatusDevice
Also called Experimental Arm
- The time selection of acupoint treatment is to return to the ward immediately,2 and 4 hours after surgery;
- Time of each stimulation: 30min;
- 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.
- 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.
CMNS6-1 Electronic Acupuncture Therapeutic ApparatusDevice
Also called Placebo
- The time selection of acupoint treatment is to return to the ward immediately,2 and 4 hours after surgery;
- Time of each stimulation: 30min;
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation group | Sham comparator | Not described Receives: Device: CMNS6-1 Electronic Acupuncture Therapeutic Apparatus |
| TENS-WAA | Experimental | CMNS6-1 Electronic Acupuncture Therapeutic Apparatus Receives: Device: CMNS6-1 Electronic Acupuncture Therapeutic Apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 668 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaonan Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaonan Huang, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931743
- Sponsor's protocol ID
- CHEC2025-074
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation Based on Wrist-Ankle Acupuncture Theory for Postoperative Pain After Thyroid Surgery: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06931743
- Acronym / sponsor ID
- CHEC2025-074
- Conditions
- Thyroid Surgery, Electrical Stimulation, Thyroid Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 668 participants (estimated)
- Lead sponsor
- Xiaonan HuangUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation group | Sham comparator | Device: CMNS6-1 Electronic Acupuncture Therapeutic Apparatus |
| TENS-WAA | Experimental | Device: CMNS6-1 Electronic Acupuncture Therapeutic ApparatusCMNS6-1 Electronic Acupuncture Therapeutic Apparatus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMNS6-1 Electronic Acupuncture Therapeutic ApparatusAlso: Experimental Arm1. 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. | Device | TENS-WAA |
| CMNS6-1 Electronic Acupuncture Therapeutic ApparatusAlso: Placebo1. 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. | Device | Sham stimulation group |
Primary outcome
Pain VAS score
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
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
4 secondary outcomes
PONV classification
Time frame: Postoperative 3 hours、Postoperative 9 hours、Postoperative 15 hours、Postoperative 24 hours
40-item Quality of Recovery (QoR-40) score
Time frame: Postoperative 24 hours
Pain-related measures
Time frame: 8.00 am on the morning after the operation
Safety indicators
Time frame: Postoperative 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMNS6-1 Electronic Acupuncture Therapeutic Apparatus in people with Thyroid Surgery and Electrical Stimulation, run by Xiaonan Huang at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ChaoQian Liu (13761030978, aj04022x@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS score (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.