Anterior Cruciate Ligament InjuriesNCT07904949
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
A study testing Experimental-Active taVNS in people with Anterior Cruciate Ligament Injuries and Recovery Quality, run by Peking University Third Hospital at 1 site in China.
Trial summary
Background: Arthroscopic anterior cruciate ligament reconstruction (ACLR) is a common orthopedic surgery. Postoperative pain, inflammatory response and opioid-related adverse events impair early recovery quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Recovery Quality, Auricular Vagus Nerve Stimulation
- What is being tested?
- Experimental-Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2026to 1 Mar 2028
- 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
Who may be able to join
- Age≥18 years old.
- Diagnosed with unilateral anterior cruciate ligament rupture, scheduled for elective arthroscopic ACL reconstruction under spinal anesthesia combined with adductor canal block.
- ASA physical status I~II.
- No contraindications to spinal anesthesia and adductor canal block.
- Voluntarily provide written informed consent.
Who cannot join
- Combined other knee ligament injuries requiring concomitant surgical repair.
- Previous knee surgery history.
- History of chronic pain or long term opioid use.
- NYHA cardiac function ≥ grade III; hepatic function Child-Pugh class C or above; eGFR <20 ml/min/1.73 m².
- Implanted electronic devices (e.g. cardiac pacemaker).
- Skin damage/infection on auricle, allergy to electrode or conductive gel.
- Pregnancy or lactation.
- Unable to complete questionnaires or cooperate with study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, 100191
Jiahong Zhou, +86 18102489803, 18102489803@163.com
Zhuoying Yu, +86 13641002503, zhuoyingyu@bjmu.edu.cn
About this study
Background: Arthroscopic anterior cruciate ligament reconstruction (ACLR) is a common orthopedic surgery. Postoperative pain, inflammatory response and opioid-related adverse events impair early recovery quality. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique with potential analgesic and anti-inflammatory effects.
Participants: A total of 144 eligible participants undergoing ACLR under spinal anesthesia combined with an adductor canal block will be enrolled.
Read more
Methods: This prospective, randomized, double-blind, sham-controlled trial will evaluate the effects of perioperative taVNS on early postoperative recovery. Participants will be randomly assigned in a 1:1 ratio to receive active taVNS or sham stimulation. Each participant will receive three 30-minute stimulation sessions, scheduled 30-45 minutes before surgery, 6 ± 1 hours after surgery, and 18 ± 1 hours after surgery. All participants will receive standardized multimodal postoperative analgesia. The primary outcome will be the score on the 15-item Quality of Recovery (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include rescue opioid consumption expressed as oral morphine equivalents, pain scores measured using the Numeric Rating Scale (NRS), functional recovery, and adverse events.
Conclusion: The investigators hypothesize that perioperative taVNS will improve early postoperative recovery quality after ACLR.
- Being tested
- Experimental-Active taVNS, Sham transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental-Active taVNSDevice
Transcutaneous auricular vagus nerve stimulation (taVNS) delivered via electrodes placed on left cymba concha. Stimulus parameters: 20 Hz frequency, pulse width 250 μs. Current is slowly increased to the subject's threshold of non-painful tingling and then reduced to sub-threshold level. Three 30-minute stimulation sessions are performed: 30-45 minutes pre-operatively, 6±1 hours post-operation, and 18±1 hours post-operation. All participants receive standardized spinal anesthesia, adductor canal block, multimodal postoperative analgesia and postoperative rehabilitation protocol.
Sham transcutaneous auricular vagus nerve stimulationDevice
Using the same equipment, the same position of the left cymba concha, and the same 30-minute timing. Each time, the current is slowly increased within 30 seconds at the beginning until the first clear but non-painful slight tingling sensation is achieved; then it is gradually reduced to 0 mA within 15 to 30 seconds, and remains at 0 mA for the rest of the time, while the screen, timing, and alert sounds continue to operate. Study participants in both groups are informed that stimulation sensation may weaken or disappear with adaptation and that sensation intensity cannot be used to determine group assignment. Anesthesia, block, postoperative analgesia, and rehabilitation training are all exactly the same as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous auricular vagus nerve stimulation | Experimental | Participants receive active transcutaneous auricular vagus nerve stimulation (taVNS) on left cymba concha in three 30-minute sessions. All participants in this arm receive standardized spinal anesthesia, adductor canal block, multimodal postoperative analgesia and standardized postoperative rehabilitation protocol. Receives: Device: Experimental-Active taVNS |
| Sham transcutaneous auricular vagus nerve stimulation | Sham comparator | Participants receive sham taVNS with identical device, electrode position (left cymba concha), timing and screen feedback as experimental group, without active therapeutic current output. All anesthesia, nerve block, analgesia and rehabilitation procedures are identical to the experimental arm. Receives: Device: Sham transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 (QoR-15) score
Validated 15-item patient-reported questionnaire assessing postoperative recovery quality. Total score ranges from 0-150; higher score indicates better postoperative recovery quality.
Measured: 24 hours after surgery
Secondary outcomes (10)
Cumulative oral morphine equivalent (OME) consumption of rescue analgesics
Total cumulative rescue opioid analgesic consumption converted to oral morphine equivalent (OME) over the observation period.
Measured: 0 to 24 hours after surgery
Time to first rescue analgesic requirement
Time interval from the end of surgery to the first administration of rescue analgesic medication for pain.
Measured: Within 24 hours after surgery
Resting NRS pain score (0-10; higher=worse pain)
Numeric Rating Scale (NRS) for pain; score range 0-10, 0 = no pain, 10 = worst imaginable pain; assessed at rest.
Measured: 0, 4, 8, 12, and 24 hours after surgery
Activity-evoked NRS pain score (passive knee flexion 45°)
Numeric Rating Scale (NRS) for pain (0-10; higher score = worse pain). Pain elicited by standardized passive knee flexion to 45 degrees. Not evaluable if regional block has not resolved.
Measured: 4, 8, 12, and 24 hours after surgery
Maximal NRS pain score
The highest observed Numeric Rating Scale pain score within the observation window (resting pain). Score range 0-10; higher score represents worse pain.
Measured: 0 to 24 hours after surgery
Time to first standardized out-of-bed mobilization
Time interval from the end of surgery until completion of the first standardized out-of-bed mobilization (sitting, standing and walking ≥3 m under assistance).
Measured: From the end of surgery until hospital discharge, approximately 1 day after surgery
Post-operative night sleep quality score (0-10; higher=better sleep)
Patient-reported sleep quality score, range 0-10; 0 = extremely poor sleep, 10 = excellent sleep. Assessed for the first night after surgery.
Measured: During the first night after surgery
Incidence of opioid-related adverse events (PONV, pruritus, urinary retention, over-sedation, respiratory depression)
Number / proportion of participants experiencing at least one opioid-related adverse event including postoperative nausea and vomiting (PONV), pruritus, urinary retention, over-sedation, respiratory depression.
Measured: 0 to 24 hours after surgery
Incidence of intervention-related adverse events (ear pain, erythema, dizziness, palpitation)
Number / proportion of participants experiencing adverse events related to taVNS intervention: ear pain, local skin erythema, dizziness, palpitation.
Measured: During stimulation sessions and the first 24 hours after surgery
Patient global satisfaction score (0-10; higher=higher satisfaction)
Patient-reported global satisfaction score, range 0-10; higher score indicates higher overall satisfaction with peri-operative care.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou JiaHong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904949
- Sponsor's protocol ID
- PKU3-M20260895
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Straube A, Eren O. tVNS in the management of headache and pain. Auton Neurosci. 2021 Dec;236:102875. doi: 10.1016/j.autneu.2021.102875. Epub 2021 Aug 31.
PubMed 34500261Dogar F, Dere KI, Bilal O, Topak D, Altun I, Kuscu B, Ozdemir MA, Gultekin MZ, Kizildag B. Comparison of the effects of endobutton continuous loop and adjustable zip loop devices on bone tunnel enlargement and clinical results in arthroscopic anterior cruciate ligament reconstruction: A retrospective observational study. Medicine (Baltimore). 2025 Feb 28;104(9):e41622. doi: 10.1097/MD.0000000000041622.
PubMed 40020114Selin AS, Gauffin H, Hedevik H, Faltstrom A, Kvist J. More knee reinjuries after ACL reconstruction compared to nonsurgical treatment of the ACL. A 2-year follow-up of the NACOX prospective cohort study. Knee Surg Sports Traumatol Arthrosc. 2025 May;33(5):1709-1720. doi: 10.1002/ksa.12473. Epub 2024 Oct 3.
PubMed 39359230
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07904949
- Acronym / sponsor ID
- PKU3-M20260895
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 29 Oct 2026 (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.
Background: Arthroscopic anterior cruciate ligament reconstruction (ACLR) is a common orthopedic surgery. Postoperative pain, inflammatory response and opioid-related adverse events impair early recovery quality. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique with potential analgesic and anti-inflammatory effects.
Participants: A total of 144 eligible participants undergoing ACLR under spinal anesthesia combined with an adductor canal block will be enrolled.
Methods: This prospective, randomized, double-blind, sham-controlled trial will evaluate the effects of perioperative taVNS on early postoperative recovery. Participants will be randomly assigned in a 1:1 ratio to receive active taVNS or sham stimulation. Each participant will receive three 30-minute stimulation sessions, scheduled 30-45 minutes before surgery, 6 ± 1 hours after surgery, and 18 ± 1 hours after surgery. All participants will receive standardized multimodal postoperative analgesia. The primary outcome will be the score on the 15-item Quality of Recovery (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include rescue opioid consumption expressed as oral morphine equivalents, pain scores measured using the Numeric Rating Scale (NRS), functional recovery, and adverse events.
Conclusion: The investigators hypothesize that perioperative taVNS will improve early postoperative recovery quality after ACLR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous auricular vagus nerve stimulation | Experimental | Device: Experimental-Active taVNSParticipants receive active transcutaneous auricular vagus nerve stimulation (taVNS) on left cymba concha in three 30-minute sessions. All participants in this arm receive standardized spinal anesthesia, adductor canal block, multimodal postoperative analgesia and standardized postoperative rehabilitation protocol. |
| Sham transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: Sham transcutaneous auricular vagus nerve stimulationParticipants receive sham taVNS with identical device, electrode position (left cymba concha), timing and screen feedback as experimental group, without active therapeutic current output. All anesthesia, nerve block, analgesia and rehabilitation procedures are identical to the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥18 years old.
- Diagnosed with unilateral anterior cruciate ligament rupture, scheduled for elective arthroscopic ACL reconstruction under spinal anesthesia combined with adductor canal block.
- ASA physical status I~II.
- No contraindications to spinal anesthesia and adductor canal block.
- Voluntarily provide written informed consent.
Key exclusion criteria (8 listed)
- Combined other knee ligament injuries requiring concomitant surgical repair.
- Previous knee surgery history.
- History of chronic pain or long term opioid use.
- NYHA cardiac function ≥ grade III; hepatic function Child-Pugh class C or above; eGFR <20 ml/min/1.73 m².
- Implanted electronic devices (e.g. cardiac pacemaker).
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 |
|---|---|---|
| Experimental-Active taVNSTranscutaneous auricular vagus nerve stimulation (taVNS) delivered via electrodes placed on left cymba concha. Stimulus parameters: 20 Hz frequency, pulse width 250 μs. Current is slowly increased to the subject's threshold of non-painful tingling and then reduced to sub-threshold level. Three 30-minute stimulation sessions are performed: 30-45 minutes pre-operatively, 6±1 hours post-operation, and 18±1 hours post-operation. All participants receive standardized spinal anesthesia, adductor canal block, multimodal postoperative analgesia and postoperative rehabilitation protocol. | Device | transcutaneous auricular vagus nerve stimulation |
| Sham transcutaneous auricular vagus nerve stimulationUsing the same equipment, the same position of the left cymba concha, and the same 30-minute timing. Each time, the current is slowly increased within 30 seconds at the beginning until the first clear but non-painful slight tingling sensation is achieved; then it is gradually reduced to 0 mA within 15 to 30 seconds, and remains at 0 mA for the rest of the time, while the screen, timing, and alert sounds continue to operate. Study participants in both groups are informed that stimulation sensation may weaken or disappear with adaptation and that sensation intensity cannot be used to determine group assignment. Anesthesia, block, postoperative analgesia, and rehabilitation training are all exactly the same as the experimental group. | Device | Sham transcutaneous auricular vagus nerve stimulation |
Primary outcome
Quality of Recovery-15 (QoR-15) score
Time frame: 24 hours after surgery
Validated 15-item patient-reported questionnaire assessing postoperative recovery quality. Total score ranges from 0-150; higher score indicates better postoperative recovery quality.
10 secondary outcomes
Cumulative oral morphine equivalent (OME) consumption of rescue analgesics
Time frame: 0 to 24 hours after surgery
Time to first rescue analgesic requirement
Time frame: Within 24 hours after surgery
Resting NRS pain score (0-10; higher=worse pain)
Time frame: 0, 4, 8, 12, and 24 hours after surgery
Activity-evoked NRS pain score (passive knee flexion 45°)
Time frame: 4, 8, 12, and 24 hours after surgery
Maximal NRS pain score
Time frame: 0 to 24 hours after surgery
Time to first standardized out-of-bed mobilization
Time frame: From the end of surgery until hospital discharge, approximately 1 day after surgery
Post-operative night sleep quality score (0-10; higher=better sleep)
Time frame: During the first night after surgery
Incidence of opioid-related adverse events (PONV, pruritus, urinary retention, over-sedation, respiratory depression)
Time frame: 0 to 24 hours after surgery
Incidence of intervention-related adverse events (ear pain, erythema, dizziness, palpitation)
Time frame: During stimulation sessions and the first 24 hours after surgery
Patient global satisfaction score (0-10; higher=higher satisfaction)
Time frame: 24 hours after surgery
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 29 Oct 2026.
- Results publication: PubMed 34500261Straube A, Eren O. tVNS in the management of headache and pain. Auton Neurosci. 2021 Dec;236:102875. doi: 10.1016/j.autneu.2021.102875. Epub 2021 Aug 31.
- Results publication: PubMed 40020114Dogar F, Dere KI, Bilal O, Topak D, Altun I, Kuscu B, Ozdemir MA, Gultekin MZ, Kizildag B. Comparison of the effects of endobutton continuous loop and adjustable zip loop devices on bone tunnel enlargement and clinical results in arthroscopic anterior cruciate ligament reconstruction: A retrospective observational study. Medicine (Baltimore). 2025 Feb 28;104(9):e41622. doi: 10.1097/MD.0000000000041622.
- Results publication: PubMed 39359230Selin AS, Gauffin H, Hedevik H, Faltstrom A, Kvist J. More knee reinjuries after ACL reconstruction compared to nonsurgical treatment of the ACL. A 2-year follow-up of the NACOX prospective cohort study. Knee Surg Sports Traumatol Arthrosc. 2025 May;33(5):1709-1720. doi: 10.1002/ksa.12473. Epub 2024 Oct 3.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental-Active taVNS in people with Anterior Cruciate Ligament Injuries and Recovery Quality, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (QoR-15) score (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07904949, which also lists 3 linked publications.
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 29 Oct 2026.