Acupuncture for Reduction of Inflammation

NCT01937520 | Completed Results

• 1 other identifier: 2012002417
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid or Parathyroid Surgery

Keywords

acupuncture; inflammation; thyroid; parathyroid

Outcome Measures

Primary Outcomes (4)

• Reduced Pain Medication Requirement

  analgesia provided in Post Anesthesia Care Unit PACU)

  amount of pain medication provided in PACU

• Visual Acuity Score (VAS)

  VAS is a self reported pain scale with a score ranging from 0 to 10. 0= no pain, 10=worst pain possible. Multiple pain sacores were recorded. single value is reported by average

  arrival in PACU to 2 hours post operatively

• Morphine Equivalent

  equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.

  PACU, day 1 , day 2, day 3

• Pain Levels

  Visual Acuity scale 0=no pain 10= worst pain possible

  PACU, day 1 , day 2, day 3

Secondary Outcomes (12)

• (ACTH )Adrenocorticotropic Hormone

  serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACU

• Morphine Equivalent

  PACU to 2 hours post op

• Morphine Equivalent (mg)

  PACU arrival to 2 hours post op

• Modified Quality of Recovery Scale

  Day 1, 2, 3

• Cortisol

  prior to surgical incision, 1 hour following incision, after arrival in PACU

Study Arms (2)

acupuncture

EXPERIMENTAL

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

device

PLACEBO COMPARATOR

no acupuncture will be done on this group of subjects

Device: no acupuncture

Interventions

acupuncture DEVICE

One half of subjects will receive a standardized acupuncture regiment

acupuncture

no acupuncture DEVICE

placebo

device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Uncontrolled high blood pressure (systolic \> 180 mm Hg (millimeters of mercury), diastolic\>110 mm Hg
• Heart block \>than first degree
• Pacemaker
• Cardiac muscle is at risk for injury
• not English speaking
• Acupuncture within the last 30 days
• If you have taken ibuprofen, advil aleve, motrin or aspirin with 5 days of the scheduled surgery.
• Prior history of drug or alcohol dependence
• If you are unable to feed, dress or bathe yourself
• If your breathing tube is not removed prior to leaving the operating room.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

Related Publications (1)

• Grech D, Li Z, Morcillo P, Kalyoussef E, Kim DD, Bekker A, Ulloa L. Intraoperative Low-frequency Electroacupuncture under General Anesthesia Improves Postoperative Recovery in a Randomized Trial. J Acupunct Meridian Stud. 2016 Oct;9(5):234-241. doi: 10.1016/j.jams.2016.03.009. Epub 2016 Apr 4.

  PMID: 27776761 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases; Inflammation

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Dennis Grech, MD
• Organization: Rutgers, The State University of New Jersey

grechde@njms.rutgers.edu

973 972-5007

Study Officials

• Dennis Grech, MD

  Rutgers/NJMS

  PRINCIPAL INVESTIGATOR

• David D Kim, PhD LaC

  Rutgers/NJMS

  PRINCIPAL INVESTIGATOR

• Alex Bekker, MD. PhD

  Rutgers/NJMS

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: September 9, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: November 23, 2016

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)