The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cholhee Park, Yonsei University
ClinicalTrials.gov Identifier:
NCT02012686
First received: December 4, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after thyroidectomy.


Condition Intervention
Thyroid Cancer
Neck Pain
Device: TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Transcutaneous Electrical Nerve Stimulation for Reduction of Posterior Neck Pain After Thyroidectomy

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy [ Time Frame: 0.5 hours after thyroidectomy ] [ Designated as safety issue: No ]
    numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

  • Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy [ Time Frame: 6 hours after thyroidectomy ] [ Designated as safety issue: No ]
    numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

  • Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy [ Time Frame: 24 hours after thyroidectomy ] [ Designated as safety issue: No ]
    numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

  • Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy [ Time Frame: 48 hours after thyroidectomy ] [ Designated as safety issue: No ]
    numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable


Enrollment: 100
Study Start Date: November 2013
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
numerical rating scale of TENS non-applied group
Active Comparator: TENS group
numerical rating scale of TENS applied group
Device: TENS
transcutaneous electric nerve stimulation frequency of 100 Hz pulse duration of 200 µs wih stimulation intensity of feeling strong but non-painful paresthesia in the upper trapezius
Other Name: LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)

Detailed Description:

Thyroidectomy is performed in supine position with the neck fully extended. After thyroidectomy, 80 percent of patients experience posterior neck pain as well as the incision site pain. The posterior neck pain is thought to be due to hyperextension is continued during an average of 90 minutes of surgery. Non-steroidal anti-inflammatory agents or opioids are administrated to reduce the pain, but the pain still remained.

TENS is simple, non-invasive analgesic technique that is used extensively to reduce acute and chronic pain. TENS has beneficial effect for the reduction of postoperative pain. The conventional way of administering TENS is to use electric characteristics that selectively activate large diameter Aβ fiber mediating touch perception without activating smaller diameter Aδ and C fiber.

In this study, TENS during thyroidectomy in posterior neck pain will be evaluated.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing open total thyroidectomy under general anesthesia
  • American Society of Anesthesiology physical status I or II

Exclusion Criteria:

  • American Society of Anesthesiology physical status III or IV
  • History of headache or neck pain within six months
  • Past history of herniated cervical disc, cervical foraminal stenosis, ossification of posterior longitudinal ligament
  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: NCT02012686

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Don Woo Han, M.D.,ph.D. Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Republic of Korea
  More Information

No publications provided

Responsible Party: Cholhee Park, clinical assisted professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02012686     History of Changes
Other Study ID Numbers: 20131127
Study First Received: December 4, 2013
Results First Received: February 28, 2014
Last Updated: May 12, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
transcutaneous electric nerve stimulation
thyroidectomy
neck pain
pain management

Additional relevant MeSH terms:
Thyroid Neoplasms
Neck Pain
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014