N/A
N=20
Acupuncture for Reduction of Inflammation
Thyroid or Parathyroid Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01937520 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Reduced Pain Medication Requirement — 5.43; 7.36 mg of Morphine
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- acupuncture (Device); no acupuncture (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduced Pain Medication Requirement |
5.43; 7.36 | — |
| PRIMARY Visual Acuity Score (VAS) |
5.36; 6.67 | — |
| PRIMARY Morphine Equivalent |
3.19; 7.36; 6.31; 9; 9.84; 7.42 | — |
| PRIMARY Pain Levels |
4.88; 6.67; 6.67; 5.56; 5; 5.93 | — |
| SECONDARY (ACTH )Adrenocorticotropic Hormone |
8.56; 21.32; 15.26; 21.41; 53.36; 202 | — |
| SECONDARY Morphine Equivalent |
3.19; 7.36; 6.31; 9; 9.84; 7.42 | — |
| SECONDARY Morphine Equivalent (mg) |
3.25; 9.69; 4.63; 5.5 | — |
| SECONDARY Modified Quality of Recovery Scale |
14.5; 13.33; 16; 15.89; 17.57; 17 | — |
| SECONDARY Cortisol |
173.6; 155.2; 103.1; 145.2; 267.4; 394.4 | — |
| SECONDARY Glucose |
150.4; 164.4; 154.3; 187.1; 152.8; 208.1 | — |
| SECONDARY Tumor Necrosis Factor (TNF) |
1.88; 2.14; 2.09; 2.25; 1.98; 1.9 | — |
| SECONDARY iNTERLEUKIN (IL-2 and IL-4) |
2.64; 4.26; 2.38; 3.4; 2.33; 2.77 | — |
| SECONDARY IL-6 |
3.58; 4.65; 4.98; 4.66; 26.96; 27.45 | — |
| SECONDARY IL-10 |
5.35; 6.0; 7.28; 7.81; 16.15; 16.14 | — |
| SECONDARY TGFB1 |
7.30; 3.26; 19.5; 9.4; 35.17; 12.9 | — |
| SECONDARY Serum Insulin Level |
257.4; 378.1; 311.2; 325.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01937520). 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.