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

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ClinicalTrials.gov Identifier: NCT02012686
Recruitment Status : Completed
First Posted : December 16, 2013
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Thyroid Cancer Neck Pain Device: TENS

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Transcutaneous Electrical Nerve Stimulation for Reduction of Posterior Neck Pain After Thyroidectomy
Study Start Date : November 2013
Primary Completion Date : January 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

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

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

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


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cholhee Park, clinical assisted professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02012686     History of Changes
Other Study ID Numbers: 20131127
First Posted: December 16, 2013    Key Record Dates
Results First Posted: June 11, 2014
Last Update Posted: June 11, 2014
Last Verified: May 2014

Keywords provided by Cholhee Park, 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