Trial Outcomes & Findings for Ear Acupuncture for Pain Associated With Ambulatory Arthroscopic Knee Surgery (NCT NCT01447329)
NCT ID: NCT01447329
Last Updated: 2024-01-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
during PACU (Post Anesthesia Care Unit) and SDSU (Same Day Surgical Unit) admissions, 24 and 48 hours, 1 week and 1 month
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
Standard Treatment Plus Ear Acupuncture
Standard treatment plus ear acupuncture
Ear Acupuncture: Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject will receive five needles intra-operatively on each ear.
|
Standard
placebo
Standard Treatment
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overall recruited versus overall analyzed.
Baseline characteristics by cohort
| Measure |
Standard Treatment Plus Ear Acupuncture
n=24 Participants
Standard treatment plus ear acupuncture
Ear Acupuncture: Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject will receive five needles intra-operatively on each ear.
|
Standard
n=25 Participants
placebo
Standard Treatment
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants • Overall recruited versus overall analyzed.
|
0 Participants
n=16 Participants • Overall recruited versus overall analyzed.
|
0 Participants
n=34 Participants • Overall recruited versus overall analyzed.
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants • Overall recruited versus overall analyzed.
|
16 Participants
n=16 Participants • Overall recruited versus overall analyzed.
|
34 Participants
n=34 Participants • Overall recruited versus overall analyzed.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants • Overall recruited versus overall analyzed.
|
0 Participants
n=16 Participants • Overall recruited versus overall analyzed.
|
0 Participants
n=34 Participants • Overall recruited versus overall analyzed.
|
|
Sex: Female, Male
Female
|
NA Participants
n=24 Participants
|
NA Participants
n=25 Participants
|
NA Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=24 Participants
|
NA Participants
n=25 Participants
|
NA Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: during PACU (Post Anesthesia Care Unit) and SDSU (Same Day Surgical Unit) admissions, 24 and 48 hours, 1 week and 1 monthOutcome measures
| Measure |
Standard Treatment Plus Ear Acupuncture
n=24 Participants
Standard treatment plus ear acupuncture
Ear Acupuncture: Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject will receive five needles intra-operatively on each ear.
|
Standard
n=25 Participants
placebo
Standard Treatment
|
|---|---|---|
|
Number of Participants With a Decrease in Pain Level
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: during PACU (Post Anesthesia Care Unit) and SDSU (Same Day Surgical Unit), 24 and 48 hours, 1 week and 1 monthOutcome measures
| Measure |
Standard Treatment Plus Ear Acupuncture
n=24 Participants
Standard treatment plus ear acupuncture
Ear Acupuncture: Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject will receive five needles intra-operatively on each ear.
|
Standard
n=25 Participants
placebo
Standard Treatment
|
|---|---|---|
|
Ability to Ambulate Without Assistance
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: during PACU (Post Anesthesia Care Unit) and SDSU (Same Day Surgical Unit) admissions, 24 and 48 hours, 1 week and 1 monthOutcome measures
| Measure |
Standard Treatment Plus Ear Acupuncture
n=24 Participants
Standard treatment plus ear acupuncture
Ear Acupuncture: Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject will receive five needles intra-operatively on each ear.
|
Standard
n=25 Participants
placebo
Standard Treatment
|
|---|---|---|
|
Number of Patients With Reduced Analgesic Use
|
18 Participants
|
16 Participants
|
Adverse Events
Standard Treatment Plus Ear Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard
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
Amanda Crawford
Mike O'Callaghan Military Medical Center, Clinical Investigation Program
Phone: (702) 653-3583
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place