N/A N=49 Randomized Triple-blind Treatment

Ear Acupuncture for Pain Associated With Ambulatory Arthroscopic Knee Surgery

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01447329 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Number of Participants With a Decrease in Pain Level — 18; 16 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ear Acupuncture (Other); Standard Treatment (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mike O'Callaghan Military Hospital
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a Decrease in Pain Level	18; 16	—
PRIMARY Ability to Ambulate Without Assistance	18; 16	—
PRIMARY Number of Patients With Reduced Analgesic Use	18; 16	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01447329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.