Acupuncture for Reduction of Inflammation

This study is currently recruiting participants.
Verified April 2014 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01937520
First received: April 24, 2013
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

This study is being done because the investigators wish to study ways to improve recovery after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the body's attempt to protect itself and to start the healing process. Some surgical complications are related to the body's natural inflammatory response. Although mainly a healing response, inflammation can also have side effects which delay recovery. The investigators wish to determine the effect of acupuncture on post-operative surgical pain. An increase in pain after surgery can cause distress for patients. Acupuncture is an alternative medicine methodology originating in China that treats patients by manipulating thin, solid needles that have been inserted into acupuncture points in the skin. Acupuncture has been used for the reduction of pain. The investigators would like to see if acupuncture during surgery can provide a lower level of pain, reduced pain medication requirement, and a lower incidence of nausea and vomiting.


Condition Intervention
Thyroid or Parathyroid Surgery
Device: acupuncture
Device: no acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Reduction of Inflammation in Thyroid and Parathyroid Surgery

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • reduced pain medication requirement [ Time Frame: from arrival to PACU to 72 hours ] [ Designated as safety issue: No ]
    Visual Acuity pain Scale with in 15 minutes of arrival to PACU record highest pain score per 24 hour period for 3 post operative days record administered pain medication to 72 hours post op


Secondary Outcome Measures:
  • change in cytokines [ Time Frame: change from baseline to immediate post op ] [ Designated as safety issue: No ]
    cytokine markers drawn pre-induction (15 min prior to induction), intraoperatively (60 minutes after skin incision)and upon arrival to PACU

  • quality of recovery [ Time Frame: change from baseline post op days # 3 ] [ Designated as safety issue: No ]
    modified Quality of Recovery-40 survey-prior to induction to determine if subject independent in Activities in daily life. Then sam survey post-op days #1,2,3


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture
acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.
Device: acupuncture
One half of subjects will receive a standardized acupuncture regiment
Placebo Comparator: device
no acupuncture will be done on this group of subjects
Device: no acupuncture
placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Not currently pregnant or beast feeding
  2. American Society of Anesthesiologists physical status of 1, 2, 3 as determined by your anesthesiologist
  3. Patients have a working telephone

Exclusion Criteria:

  1. Uncontrolled high blood pressure (systolic > 180mmHg, diastolic>110mmHg
  2. Heart block >than first degree
  3. Pacemaker
  4. Cardiac muscle is at risk for injury
  5. not English speaking
  6. Acupuncture within the last 30 days
  7. If you have taken ibuprofen, advil aleve, motrin or aspirin with 5 days of the scheduled surgery.
  8. Prior history of drug or alcohol dependence
  9. If you are unable to feed, dress or bathe yourself
  10. If your breathing tube is not removed prior to leaving the operating room.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01937520

Contacts
Contact: Dennis Grech, MD 973 972-2929 grechgde@umdnj.edu
Contact: Catherine Schoenberg, BSN 973 972-7477 shoenbce@umdnj.edu

Locations
United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07101
Contact: Dennis Grech, MD    973-972-7477    grechde@umdnj.edu   
Contact: Catherine Schoenberg, BSN    973 972-7477    shoenbce@umdnj.edu   
Principal Investigator: Dennis Grech, MD         
Sub-Investigator: Vanny Le, MD         
Sub-Investigator: Alex Bekker, MD, PhD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Dennis Grech, MD UMDNJ/NJMS
Principal Investigator: David D Kim, PhD LaC UMDNJ/NJMS
Study Chair: Alex Bekker, MD. PhD UMDNJ/NJMS
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01937520     History of Changes
Other Study ID Numbers: 2012002417
Study First Received: April 24, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
acupuncture
inflammation
thyroid
parathyroid

Additional relevant MeSH terms:
Inflammation
Thyroid Diseases
Pathologic Processes
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014