Clinical trial

Ear Acupuncture for Post-operative Pain Associated With Ambulatory Arthroscopic Knee Surgery - A Randomized Controlled Trial

Name

FWH20110169H

Description

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 arms

Trial start

2011-12-01

Estimated PCD

2014-01-01

Trial end

2014-01-01

Status

Completed

Treatment

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.

Arms:

Standard treatment plus ear acupuncture

Other names:

Sedatelec ASP Original Gold needles

Standard Treatment

Arms:

standard

Size

Primary endpoint

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

Eligibility criteria

Inclusion: * 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. Exclusion: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

Updated at

2024-01-19

1 organization

1 product

1 indication

Organization

Mike O'Callaghan Military Hospital

Product

Standard Treatment

Indication

Pain