AcupunctureNCT05384860
Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery
A study testing Auricular Trauma Protocol (ATP) Acupuncture and No Acupuncture Group in people with Acupuncture and Hip Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
At this time, no formal ERAS (enhanced recovery after surgery) protocol exists for THR that incorporates perioperative acupuncture. Developing, and more importantly, validating a preliminary fast-track protocol for THR can have a significant impact on reducing recovery time and improving the rate at which this… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acupuncture, Hip Surgery, Opioid Use
- What is being tested?
- Auricular Trauma Protocol (ATP) Acupuncture and No Acupuncture Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status of 1 or 2
- Ages 18-80
- Undergoing a total hip replacement
- Ability to follow study protocol
- English-speaking
Who cannot join
- Non-English speaking
- Chronic opioids use (6 weeks or more)
- Contraindication to neuraxial anesthesia or peripheral nerve block
- Intending to receive general anesthesia
- Contraindication to intra-op protocol
- Implanted cardiac device (i.e. pacemaker)
Show all 10Show fewer
- Active ear infection
- Non-native ear, previous scarring or surgery
- Ear gauges or other deforming ear piercing
- Allergy to Nickel
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
At this time, no formal ERAS (enhanced recovery after surgery) protocol exists for THR that incorporates perioperative acupuncture. Developing, and more importantly, validating a preliminary fast-track protocol for THR can have a significant impact on reducing recovery time and improving the rate at which this subgroup of surgeries is done on an outpatient basis. Furthermore, previous studies of acupuncture as an adjunctive therapy for postoperative analgesia have primarily investigated patient satisfaction rather than the impact on postoperative opioid consumption.
The majority of studies also place acupuncture needles preoperatively, rather than following induction of anesthesia (intra-operatively). This study hopes to show that placing auricular therapy needles intraoperatively is a feasible part of a protocol for motivated patients to minimize opioids after total knee arthroplasty. The prospect of incorporating intraoperative acupuncture as an adjunct into said protocol is very attractive given its low cost, its safety profile, its ease of administration, and the growing evidence supporting its efficacy. This study would provide further clarity on whether perioperative acupuncture can effectively reduce hospital length of stay and post-operative opioid consumption, in addition to evaluating the role of perioperative acupuncture in improving recovery after THR as part of a multimodal fast-track protocol.
- Conditions
- Acupuncture, Hip Surgery, Opioid Use
- Being tested
- Auricular Trauma Protocol (ATP) Acupuncture, No Acupuncture Group
- Keywords
- hip surgery, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Trauma Protocol (ATP) AcupunctureDevice
Small filiform (needle) like needles use low frequency electrostimulation at eight ear points for 60 minutes while patient is sedated during surgery. All other aspects of the surgical procedure will go as planned according to the hospital's standard of care.
No Acupuncture GroupOther
This involves not receiving the acupuncture treatment and surgery going entirely as normal according to the hospital's standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Active Acupuncture Group | Active comparator | For the patients randomized to the acupuncture group, once sedation has been deemed adequate by the anesthesiologist, a certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. Receives: Device: Auricular Trauma Protocol (ATP) Acupuncture |
| Placebo No Acupuncture Group | Placebo comparator | These patients will not receive acupuncture treatment during surgery, their surgery will continue as normal. Receives: Other: No Acupuncture Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Usage
The primary outcome is the incidence of patients who maintain a low-dose opioid regimen (71.5 OME or less) out to 30 days post-op. Patient intake of opioid medication will be measured up to the 30 days post-operation.
Measured: Day 30
Secondary outcomes (7)
NRS Pain Scores
NRS pain scores at rest and with movement
Measured: Post-operatively in: PACU (post-anesthesia care unit) immediately post-operation, Day 1, Day 2, Day 14 & Day 30
Satisfaction with Protocol
Satisfaction with the whole protocol/study experience and pain management throughout surgery and recovery. Patients will be asked to rate their satisfaction with the study, care provided and pain management on a scale of 1-10 with 1 being least satisfied and 10 being most satisfied.
Measured: Day 30
Post-operative Nausea & Vomiting (PONV)
Incidence of nausea, vomiting, pruritus, constipation
Measured: Post-operatively in: PACU (post-anesthesia care unit), Day 1
Range of Motion
Postoperative range of motion (extension and flexion)
Measured: Post-operatively on: Day 1 and Day 14
Pain Catastrophizing Scale (PCS)
13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. It is a self-reported measure with items scored from 0-4 with 4 being the most catastrophic. The higher a patient's total scores the more catastrophic their thoughts are in relation to pain.
Measured: Pre-operative
Center for Epidemiologic Studies Short Depression Scale & Anxiety Scale (CES-D)
20 questions that asks about various symptoms of depression as they have occurred in the past week. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Total scores range from 0 to 60, with higher scores indicated greater depressive symptoms.
Measured: Pre-operative
Hours to Discharge
The total number of hours patients spend in the hospital until discharge from the hospital. This will be measured from the start of surgery in the OR until discharge from hospital.
Measured: Will be assessed up to 4 days post-operatively or until patient leaves hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start6 Jul 2022
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Model description
- Subjects were randomly assigned to receive Acupuncture, or No Acupuncture based on a 1:1 schedule with blocks of four created prior to study initiation using SAS version 9.4 (SAS Institute; Cary, NC) by a member of the biostatistics core not otherwise involved in the trial. Treatment assignments were transcribed onto notecards and sealed in opaque, consecutively numbered envelopes by a research assistant not otherwise involved in the trial. After patient consent and prior to anesthesia start, the research assistant involved in the trial handed the randomization envelope to the medical acupuncturist. All patients and research assistants involved with data collection will be blinded to the group allocation. Randomization lists will be accessed by an intra-op monitor RA who is not otherwise involved in the study in any other aspect.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Cheng, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384860
- Sponsor's protocol ID
- 2021-1496
- Status last verified
- Feb 2025
- First submitted
- 5 May 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery
- ClinicalTrials.gov ID
- NCT05384860
- Acronym / sponsor ID
- 2021-1496
- Conditions
- Acupuncture, Hip Surgery, Opioid Use
- Keywords
- hip surgery, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 20 May 2022 (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.
At this time, no formal ERAS (enhanced recovery after surgery) protocol exists for THR that incorporates perioperative acupuncture. Developing, and more importantly, validating a preliminary fast-track protocol for THR can have a significant impact on reducing recovery time and improving the rate at which this subgroup of surgeries is done on an outpatient basis. Furthermore, previous studies of acupuncture as an adjunctive therapy for postoperative analgesia have primarily investigated patient satisfaction rather than the impact on postoperative opioid consumption.
The majority of studies also place acupuncture needles preoperatively, rather than following induction of anesthesia (intra-operatively). This study hopes to show that placing auricular therapy needles intraoperatively is a feasible part of a protocol for motivated patients to minimize opioids after total knee arthroplasty. The prospect of incorporating intraoperative acupuncture as an adjunct into said protocol is very attractive given its low cost, its safety profile, its ease of administration, and the growing evidence supporting its efficacy. This study would provide further clarity on whether perioperative acupuncture can effectively reduce hospital length of stay and post-operative opioid consumption, in addition to evaluating the role of perioperative acupuncture in improving recovery after THR as part of a multimodal fast-track protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects were randomly assigned to receive Acupuncture, or No Acupuncture based on a 1:1 schedule with blocks of four created prior to study initiation using SAS version 9.4 (SAS Institute; Cary, NC) by a member of the biostatistics core not otherwise involved in the trial. Treatment assignments were transcribed onto notecards and sealed in opaque, consecutively numbered envelopes by a research assistant not otherwise involved in the trial. After patient consent and prior to anesthesia start, the research assistant involved in the trial handed the randomization envelope to the medical acupuncturist. All patients and research assistants involved with data collection will be blinded to the group allocation. Randomization lists will be accessed by an intra-op monitor RA who is not otherwise involved in the study in any other aspect.
| Arm | Type | Receives |
|---|---|---|
| Active Acupuncture Group | Active comparator | Device: Auricular Trauma Protocol (ATP) AcupunctureFor the patients randomized to the acupuncture group, once sedation has been deemed adequate by the anesthesiologist, a certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. |
| Placebo No Acupuncture Group | Placebo comparator | Other: No Acupuncture GroupThese patients will not receive acupuncture treatment during surgery, their surgery will continue as normal. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA status of 1 or 2
- Ages 18-80
- Undergoing a total hip replacement
- Ability to follow study protocol
- English-speaking
Key exclusion criteria (10 listed)
- Non-English speaking
- Chronic opioids use (6 weeks or more)
- Contraindication to neuraxial anesthesia or peripheral nerve block
- Intending to receive general anesthesia
- Contraindication to intra-op protocol
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 |
|---|---|---|
| Auricular Trauma Protocol (ATP) AcupunctureSmall filiform (needle) like needles use low frequency electrostimulation at eight ear points for 60 minutes while patient is sedated during surgery. All other aspects of the surgical procedure will go as planned according to the hospital's standard of care. | Device | Active Acupuncture Group |
| No Acupuncture GroupThis involves not receiving the acupuncture treatment and surgery going entirely as normal according to the hospital's standard of care. | Other | Placebo No Acupuncture Group |
Primary outcome
Opioid Usage
Time frame: Day 30
The primary outcome is the incidence of patients who maintain a low-dose opioid regimen (71.5 OME or less) out to 30 days post-op. Patient intake of opioid medication will be measured up to the 30 days post-operation.
7 secondary outcomes
NRS Pain Scores
Time frame: Post-operatively in: PACU (post-anesthesia care unit) immediately post-operation, Day 1, Day 2, Day 14 & Day 30
Satisfaction with Protocol
Time frame: Day 30
Post-operative Nausea & Vomiting (PONV)
Time frame: Post-operatively in: PACU (post-anesthesia care unit), Day 1
Range of Motion
Time frame: Post-operatively on: Day 1 and Day 14
Pain Catastrophizing Scale (PCS)
Time frame: Pre-operative
Center for Epidemiologic Studies Short Depression Scale & Anxiety Scale (CES-D)
Time frame: Pre-operative
Hours to Discharge
Time frame: Will be assessed up to 4 days post-operatively or until patient leaves hospital.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
Stephanie Cheng, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Trauma Protocol (ATP) Acupuncture and No Acupuncture Group in people with Acupuncture and Hip Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Usage (time frame: Day 30). 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 11 Dec 2025.