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Acupuncture for Reduction of Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01937520
First received: April 24, 2013
Last updated: October 4, 2016
Last verified: July 2016
  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: Randomized, Prospective Double Blind Pilot Clinical Trial

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: amount of pain medication provided in PACU ] [ Designated as safety issue: No ]
    analgesia provided in Post Anesthesia Care Unit PACU)

  • Visual Acuity Score (VAS) [ Time Frame: arrival in PACU to 2 hours post operatively ] [ Designated as safety issue: No ]
    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

  • Morphine Equivalent [ Time Frame: PACU, day 1 , day 2, day 3 ] [ Designated as safety issue: No ]
    equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.

  • Pain Levels [ Time Frame: PACU, day 1 , day 2, day 3 ] [ Designated as safety issue: No ]
    Visual Acuity scale 0=no pain 10= worst pain possible


Secondary Outcome Measures:
  • (ACTH )Adrenocorticotropic Hormone [ Time Frame: serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACU ] [ Designated as safety issue: No ]
    All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia. The data below represents female patients only

  • Morphine Equivalent [ Time Frame: PACU to 2 hours post op ] [ Designated as safety issue: No ]
    All analgesic treatments were converted to morphine equivalents in milligrams .

  • Morphine Equivalent (mg) [ Time Frame: PACU arrival to 2 hours post op ] [ Designated as safety issue: No ]
    morphine equivalent to analyze whether body weight affected the efficacy of electroacupuncture

  • Modified Quality of Recovery Scale [ Time Frame: Day 1, 2, 3 ] [ Designated as safety issue: No ]
    Modified patient self reported scale with 9 questions regarding general well being including ability to eat, free from constant pain, able to manage activities of daily living. 0= worst possible score and 18=best outcome score

  • Cortisol [ Time Frame: prior to surgical incision, 1 hour following incision, after arrival in PACU ] [ Designated as safety issue: No ]
    All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.

  • Glucose [ Time Frame: serum glucose from baseline to PACU arrival ] [ Designated as safety issue: No ]
    the first two blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.

  • Tumor Necrosis Factor (TNF) [ Time Frame: preoperatively-intraoperatively-postoperatively ] [ Designated as safety issue: No ]
    First two blood samples were collected during general anesthesia, first prior to surgical incision and Electro-acupuncture (EA), 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia. TNF is a critical pyrogen produced during acute phase of a reaction to trauma.

  • iNTERLEUKIN (IL-2 and IL-4) [ Time Frame: Preoperatively-intraoperatively-postoperatively ] [ Designated as safety issue: No ]
    both are IL-2 and IL-4 are critical cytokines regulating the cellular response to induce cellular versus hormone immunity. First two blood samples were collected during general anesthesia: first prior to surgical incision and electroacupuncture, second 60 minutes after incision and electroacupuncture and the 3rd after arrival in PACU but before analgesia.

  • IL-6 [ Time Frame: Preoperatively-intraoperatively-postoperatively ] [ Designated as safety issue: No ]
    First two blood samples were collected during general anesthesia, first prior to Surgical incision and EA, 2nd 60 minutes after incision and EA and the 3rd after arrival in PACU but before administration of analgesia. IL-6 is a critical inflammatory cytokine produced during the acute phase of reaction to trauma

  • IL-10 [ Time Frame: Preoperatively-intraoperatively-postoperatively ] [ Designated as safety issue: No ]
    IL-10 is an anti-inflammatory cytokine marker. First two blood samples were collected during general anesthesia, first prior to surgical incision and EA, 2nd 60 minutes following incision and EA, and the third after arrival in PACU but before administration of analgesia.

  • TGFB1 [ Time Frame: Preoperatively-intraoperatively-postoperatively ] [ Designated as safety issue: No ]
    TGFB1 is a pleiotropic factor regulating the immune system and healing. First two blood samples drawn under general anesthesia, first prior to surgical incision and EA, the 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia.

  • Serum Insulin Level [ Time Frame: preoperative and postoperative ] [ Designated as safety issue: No ]
    to determine if electroacupuncture reduced hyperglycemia


Enrollment: 20
Study Start Date: July 2013
Study Completion Date: April 2015
Primary Completion Date: July 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   (Adult, Senior)
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 > 180 mm Hg (millimeters of mercury), diastolic>110 mm Hg
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937520

Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Dennis Grech, MD Rutgers/NJMS
Principal Investigator: David D Kim, PhD LaC Rutgers/NJMS
Study Chair: Alex Bekker, MD. PhD Rutgers/NJMS
  More Information

Publications:
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
Results First Received: December 2, 2015
Last Updated: October 4, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: data is in results section

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 December 02, 2016