ACLNCT03711734
Acupuncture ACL (Anterior Cruciate Ligament)
A study of ACL and ACL Injury, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations… Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL, ACL Injury, Anterior Cruciate Ligament Injury
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 13 Dec 2019
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing ACL Surgery with a participating surgeon
- English Speaking
- Patients at least 12 years old
- Planned spinal anesthesia without peripheral nerve block (rescue block is okay)
Who cannot join
- Patients under the age of 12
- Non-English speaking patients
- Patients planning on having general anesthesia
- Planned preop peripheral nerve block
- Patients with the inability to understand/follow study protocol
- Patients with pacemaker/AICD
Show all 13Show fewer
- Non-native Ear/Previous scarring/surgical manipulation of ear
- Patients with contraindications to intra-op protocol
- Chronic pain patients
- Patients who have regularly used opioids for more than 6 weeks prior to surgery
- Patients with guages in their ears
- Patients who refuse to remove earrings/piercings prior to surgery
- Patients with nickel allergies (needles are made of 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: Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.
Read the detailed description
According to the most recent survey conducted by the national center for complementary and integrative health (a branch of the National Institutes of Health) in 2007, the use of complementary alternative medicine (CAM) has increased significantly from 2002 (the previous survey). In the 2007 survey, in the United States alone, 38% percent of adults and 12% of children use some form of CAM. It has been 10 years since that survey report, there is little doubt that these numbers have only increased. According to the National Center for Health Statistics on the expenditures on CAM in 2012 - for just adults utilizing specialists, such as acupuncturists, $14.1 Billion was spent. With this increasing demand of such treatment modalities by patients, conventional practitioners will need to be, at the very least, well versed enough to recommend for or against these modalities. In addition, the current opioid epidemic is on the forefront of the public mind. Recently declared a public health emergency by the President, alternative means of postoperative pain control is a necessity and integrative medicine is a low cost, safe, and effective adjuvant/alternative
- Conditions
- ACL, ACL Injury, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Anesthesia
- Being tested
- Acupuncture + Standard of Care
- Keywords
- Acupuncture
- 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.
Acupuncture + Standard of CareOther
Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture + Standard of Care | Experimental | Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen.
Patients will have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally with electrostimulation at Shen men and Hypothalamus at 30 hz. Receives: Other: Acupuncture + Standard of Care |
| No acupuncture + Standard of Care | No intervention | Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen. Patients will not have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bang Blinding Index (BI)
Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using Bang Blinding Index (BI) which ranges from min = -1 to max = 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.
Measured: postoperative day 1
Secondary outcomes (3)
Numeric Rating Scale (NRS) Pain at Rest Scores
Numeric Rating Scale (NRS) pain at rest on a scale of 0 (no pain) to 10 (worst pain ever imaginable). A lower score is a better outcome.
Measured: postoperative day 1
Numeric Rating Scale (NRS) Pain With Movement Scores
Numeric Rating Scale (NRS) pain with movement on a scale of 0 (no pain) to 10 (worst pain imaginable). A lower score is a better outcome.
Measured: postoperative day 1
Opioid Consumption
Measured in cumulative oral morphine equivalent. Each patient measured individually and then all patients' measurement was averaged.
Measured: day of surgery through postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Nov 2018
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACLStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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 Surgey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711734
- Sponsor's protocol ID
- 2018-1478
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2018
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng SI, Norman RM, DeMeo D, Zhong H, Turteltaub LH, McCarthy MM, Marx RG, Strickland SM, Kelly AM. The Feasibility of Blinding Intraoperative Electro-Auricular Acupuncture Under Neuraxial Anesthesia. Med Acupunct. 2021 Aug 1;33(4):286-294. doi: 10.1089/acu.2021.0003. Epub 2021 Aug 17.
PubMed 34471447
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
- Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
- ClinicalTrials.gov ID
- NCT03711734
- Acronym / sponsor ID
- 2018-1478
- Conditions
- ACL, ACL Injury, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture, Anesthesia
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.
Detailed description
According to the most recent survey conducted by the national center for complementary and integrative health (a branch of the National Institutes of Health) in 2007, the use of complementary alternative medicine (CAM) has increased significantly from 2002 (the previous survey). In the 2007 survey, in the United States alone, 38% percent of adults and 12% of children use some form of CAM. It has been 10 years since that survey report, there is little doubt that these numbers have only increased. According to the National Center for Health Statistics on the expenditures on CAM in 2012 - for just adults utilizing specialists, such as acupuncturists, $14.1 Billion was spent. With this increasing demand of such treatment modalities by patients, conventional practitioners will need to be, at the very least, well versed enough to recommend for or against these modalities. In addition, the current opioid epidemic is on the forefront of the public mind. Recently declared a public health emergency by the President, alternative means of postoperative pain control is a necessity and integrative medicine is a low cost, safe, and effective adjuvant/alternative
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture + Standard of Care | Experimental | Other: Acupuncture + Standard of CarePatients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen. Patients will have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally with electrostimulation at Shen men and Hypothalamus at 30 hz. |
| No acupuncture + Standard of Care | No intervention | –Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen. Patients will not have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing ACL Surgery with a participating surgeon
- English Speaking
- Patients at least 12 years old
- Planned spinal anesthesia without peripheral nerve block (rescue block is okay)
Key exclusion criteria (13 listed)
- Patients under the age of 12
- Non-English speaking patients
- Patients planning on having general anesthesia
- Planned preop peripheral nerve block
- Patients with the inability to understand/follow study 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 |
|---|---|---|
| Acupuncture + Standard of CareAcupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan. | Other | Acupuncture + Standard of Care |
Primary outcome
Bang Blinding Index (BI)
Time frame: postoperative day 1
Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using Bang Blinding Index (BI) which ranges from min = -1 to max = 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.
3 secondary outcomes
Numeric Rating Scale (NRS) Pain at Rest Scores
Time frame: postoperative day 1
Numeric Rating Scale (NRS) Pain With Movement Scores
Time frame: postoperative day 1
Opioid Consumption
Time frame: day of surgery through postoperative day 1
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.
- Derived from this study: PubMed 34471447Cheng SI, Norman RM, DeMeo D, Zhong H, Turteltaub LH, McCarthy MM, Marx RG, Strickland SM, Kelly AM. The Feasibility of Blinding Intraoperative Electro-Auricular Acupuncture Under Neuraxial Anesthesia. Med Acupunct. 2021 Aug 1;33(4):286-294. doi: 10.1089/acu.2021.0003. Epub 2021 Aug 17.
- Individual participant dataSharing planned: No
Related trials for ACL
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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 Surgey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of ACL and ACL Injury, 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 13 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 26 Apr 2024). 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?
Bang Blinding Index (BI) (time frame: postoperative day 1). 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 NCT03711734, which also lists 1 linked publication.
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.