NCT01447329

Brief Summary

The investigators propose to complete a randomized controlled trial to compare ear acupuncture at Cingulate gyrus, thalamus, omega 2, shen-men, and point zero on the right and left ear plus standard of care versus standard of care alone for symptomatic treatment of pain following ambulatory arthroscopic knee surgery. After the subject has been discharged, phone calls, emails or text messages will be made at 24 and 48 hours, 1 week and 1 month. These contacts will be used to assess the subject's pain level, ambulation status, doses of analgesics taken and time to return to full duty. At 1 week and 1 month, subjects will be asked the PIQ-6 Pain Impact Questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

January 19, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

October 4, 2011

Results QC Date

March 11, 2019

Last Update Submit

January 17, 2024

Conditions

Pain

Keywords

painacupuncturekneedebridementsurgeryarthroscopic knee surgery debridement

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With a Decrease in Pain Level

    during PACU (Post Anesthesia Care Unit) and SDSU (Same Day Surgical Unit) admissions, 24 and 48 hours, 1 week and 1 month

  • Ability to Ambulate Without Assistance

    during PACU (Post Anesthesia Care Unit) and SDSU (Same Day Surgical Unit), 24 and 48 hours, 1 week and 1 month

  • Number of Patients With Reduced Analgesic Use

    during PACU (Post Anesthesia Care Unit) and SDSU (Same Day Surgical Unit) admissions, 24 and 48 hours, 1 week and 1 month

Study Arms (2)

Standard treatment plus ear acupuncture

EXPERIMENTAL

Standard treatment plus ear acupuncture

Other: Ear Acupuncture

standard

PLACEBO COMPARATOR

placebo

Drug: Standard Treatment

Interventions

Ear AcupunctureOTHER

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.

Also known as: Sedatelec ASP Original Gold needles
Standard treatment plus ear acupuncture
Standard TreatmentDRUG
standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tricare beneficiaries receiving care at Nellis AFB.
  • Male and female subjects (DoD beneficiaries), 18 years or older scheduled for ambulatory unilateral arthroscopic knee surgery.
  • Unilateral arthroscopic knee surgery debridement.

You may not qualify if:

  • History of significant gastrointestinal bleed
  • Previous documented history of stage 2 kidney disease or worse
  • Pregnant or breastfeeding
  • History of gastric bypass surgery
  • Chronic oral steroids use
  • Absence of ear
  • Active cellulitis of ear
  • Ear anatomy precluding identification of acupuncture landmarks
  • Non-English speaking
  • Taking Coumadin or any Heparin-based anticoagulant
  • Use of Hearing Aids that preclude the insertion of ASP needles
  • Allergy to study medications
  • Inability to comply with study protocol
  • Arthroscopic knee surgery with ligamentous repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Federal Hospital

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Results Point of Contact

Title
Amanda Crawford
Organization
Mike O'Callaghan Military Medical Center, Clinical Investigation Program
amanda.j.crawford.ctr@health.mil
(702) 653-3583

Study Officials

  • David Moss, M.D. Capt

    Mike O'Callaghan Federal Hospital/Nellis AFB

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 6, 2011

Study Start

December 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 19, 2024

Results First Posted

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)