Trial Outcomes & Findings for Acupuncture ACL (Anterior Cruciate Ligament) (NCT NCT03711734)
NCT ID: NCT03711734
Last Updated: 2024-12-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
postoperative day 1
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Acupuncture + Standard of Care
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.
Acupuncture + Standard of Care: 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.
|
No Acupuncture + Standard of Care
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture ACL (Anterior Cruciate Ligament)
Baseline characteristics by cohort
| Measure |
Acupuncture + Standard of Care
n=20 Participants
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.
Acupuncture + Standard of Care: 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.
|
No Acupuncture + Standard of Care
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 13 • n=7 Participants
|
32 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: postoperative day 1Population: One patient was lost to follow up.
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.
Outcome measures
| Measure |
Acupuncture + Standard of Care
n=20 Participants
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.
Acupuncture + Standard of Care: 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.
|
No Acupuncture + Standard of Care
n=19 Participants
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.
|
|---|---|---|
|
Bang Blinding Index (BI)
|
0.2 score on a scale
Interval -0.02 to 0.42
|
0.11 score on a scale
Interval -0.1 to 0.31
|
SECONDARY outcome
Timeframe: postoperative day 1Population: One patient was lost to follow up.
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.
Outcome measures
| Measure |
Acupuncture + Standard of Care
n=20 Participants
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.
Acupuncture + Standard of Care: 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.
|
No Acupuncture + Standard of Care
n=19 Participants
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.
|
|---|---|---|
|
Numeric Rating Scale (NRS) Pain at Rest Scores
|
4.3 score on a scale
Standard Deviation 1.8
|
4.1 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: postoperative day 1Population: Some patients were lost to follow up.
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.
Outcome measures
| Measure |
Acupuncture + Standard of Care
n=19 Participants
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.
Acupuncture + Standard of Care: 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.
|
No Acupuncture + Standard of Care
n=18 Participants
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.
|
|---|---|---|
|
Numeric Rating Scale (NRS) Pain With Movement Scores
|
5.2 score on a scale
Standard Deviation 1.9
|
4.6 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: day of surgery through postoperative day 1Measured in cumulative oral morphine equivalent. Each patient measured individually and then all patients' measurement was averaged.
Outcome measures
| Measure |
Acupuncture + Standard of Care
n=20 Participants
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.
Acupuncture + Standard of Care: 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.
|
No Acupuncture + Standard of Care
n=20 Participants
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.
|
|---|---|---|
|
Opioid Consumption
|
47.8 oral morphine equivalent
Standard Deviation 34.6
|
46.3 oral morphine equivalent
Standard Deviation 25.3
|
Adverse Events
Acupuncture + Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Acupuncture + Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place