Knee OsteoarthritisNCT04084288
Acupuncture for Low-Dose Opioid for TKA Replacement
A study testing Acupuncture and Peripheral Nerve Stimulator in people with Knee Osteoarthritis and Pain, Postoperative, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The majority of patients undergoing total knee replacement(TKR) rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Pain, Postoperative, Acupuncture
- What is being tested?
- Acupuncture and Peripheral Nerve Stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA of 1 or 2
- Age 18-70
- Undergoing primary total knee replacement
- Desire to attempt a low opioid or opioid free pathway
Who cannot join
- NonEnglish speaking
- Patients with the inability to understand or follow study protocol
- Opioid use in the last 6 weeks or chronic pain patient
- Cannot receive neuraxial anesthesia and/or peripheral nerve block
- Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease)
- Patients with implanted cardiac device such as a pacemaker or AICD
Show all 10Show fewer
- Active ear infection
- Nonnative ear, previous scarring or surgical manipulation of ear
- Patients with gauges or other deforming ear piercing (small nondeforming ear piercings are ok) present in ears
- 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
Official title: Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study
The majority of patients undergoing total knee replacement(TKR) rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. The aim of this cohort study is to determine the incidence rate of patients who are able to maintain a low dose opioid regimen after TKR with the use of a multimodal approach that includes intraoperative auricular acupuncture protocol.
Read the detailed description
This is a prospective cohort study to assess the feasibility of patients to undergo TKR while adhering to a low-dose opioid regimen by using a multimodal analgesic approach that includes intraoperativeauricular acupuncture. We hypothesize that it will be feasible to maintain a low-dose opioid regimen during TKR while followingthe intraoperative auricular acupuncture protocol, and that patients will be satisfied with their pain control with a low incidence of adverse events.
- Conditions
- Knee Osteoarthritis, Pain, Postoperative, Acupuncture
- Being tested
- Acupuncture, Peripheral Nerve Stimulator
- Keywords
- Acupuncture, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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
Peripheral Nerve StimulatorDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Acupuncture | Experimental | Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request.
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. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room.
A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) Receives: Other: Acupuncture; Device: Peripheral Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-dose Opioid Regimen Adherence
The number of patients who maintain a low-dose opioid regimen (15 pills or less of 5mg oxycodone or 112.5 OME [oral morphine equivalents]) from postoperative day (POD) 0 to POD 30 throughout their Total Knee Replacement.
Measured: postoperative day 0 to postoperative day 30
Secondary outcomes (7)
Total Opioid Consumption
Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints
Measured: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
Numerical Rating Scale (NRS) pain scores at rest and with movement. NRS pain is measured from 0 to 10, with 0 being the no pain whatsoever and 10 being the worst pain imaginable.
Measured: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Duration of Neuraxial Anesthesia in Hours
Duration of neuraxial anesthesia is defined as number of hours between anesthesia start time to anesthesia stop time.
Measured: postoperative day 1
Deviation From Prescribed Oral Pain Regimen
Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30
Measured: Postoperative day 30
Number of Participants With Side Effects on POD1 and During the PACU Stay
Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1
Measured: PACU, Postoperative day 1
Postoperative Range of Motion
Postoperative range of motion measured at the 6 week surgeon office visit. This is being measured by either the physician or their PA and is a score that is achieved by adding extension and flexion together. It is measured in degrees. (example: flexion: 118 + extension:1 = score: 119)
Measured: 6 weeks postoperative (surgeon office visit)
Tourniquet Time
Duration of time the tourniquet is inflated intraoperatively. Measured in minutes
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start21 Aug 2019
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT04084288
- Sponsor's protocol ID
- 2019-1193
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2019
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04084288
- Acronym / sponsor ID
- 2019-1193
- Conditions
- Knee Osteoarthritis, Pain, Postoperative, Acupuncture
- Keywords
- Acupuncture, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 5 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The majority of patients undergoing total knee replacement(TKR) rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. The aim of this cohort study is to determine the incidence rate of patients who are able to maintain a low dose opioid regimen after TKR with the use of a multimodal approach that includes intraoperative auricular acupuncture protocol.
Detailed description
This is a prospective cohort study to assess the feasibility of patients to undergo TKR while adhering to a low-dose opioid regimen by using a multimodal analgesic approach that includes intraoperativeauricular acupuncture. We hypothesize that it will be feasible to maintain a low-dose opioid regimen during TKR while followingthe intraoperative auricular acupuncture protocol, and that patients will be satisfied with their pain control with a low incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Acupuncture | Experimental | Other: Acupuncture, Device: Peripheral Nerve StimulatorNeuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request. 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. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room. A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA of 1 or 2
- Age 18-70
- Undergoing primary total knee replacement
- Desire to attempt a low opioid or opioid free pathway
Key exclusion criteria (10 listed)
- NonEnglish speaking
- Patients with the inability to understand or follow study protocol
- Opioid use in the last 6 weeks or chronic pain patient
- Cannot receive neuraxial anesthesia and/or peripheral nerve block
- Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease)
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 |
|---|---|---|
| AcupunctureIpsilateral 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 | Other | Postoperative Acupuncture |
| Peripheral Nerve StimulatorIpsilateral 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). | Device | Postoperative Acupuncture |
Primary outcome
Low-dose Opioid Regimen Adherence
Time frame: postoperative day 0 to postoperative day 30
The number of patients who maintain a low-dose opioid regimen (15 pills or less of 5mg oxycodone or 112.5 OME [oral morphine equivalents]) from postoperative day (POD) 0 to POD 30 throughout their Total Knee Replacement.
7 secondary outcomes
Total Opioid Consumption
Time frame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
Time frame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Duration of Neuraxial Anesthesia in Hours
Time frame: postoperative day 1
Deviation From Prescribed Oral Pain Regimen
Time frame: Postoperative day 30
Number of Participants With Side Effects on POD1 and During the PACU Stay
Time frame: PACU, Postoperative day 1
Postoperative Range of Motion
Time frame: 6 weeks postoperative (surgeon office visit)
Tourniquet Time
Time frame: Intraoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (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 Acupuncture and Peripheral Nerve Stimulator in people with Knee Osteoarthritis and Pain, Postoperative, 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 4 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 27 Dec 2024. 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. 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?
Yes. Results are posted in the registry (first posted 5 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Low-dose Opioid Regimen Adherence (time frame: postoperative day 0 to postoperative 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 27 Dec 2024.