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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012686
• Other study ID #: 20131127
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: May 12, 2014
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain
• Thyroid Cancer
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy	numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable	0.5 hours after thyroidectomy	No
Primary	Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy	numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable	6 hours after thyroidectomy	No
Primary	Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy	numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable	24 hours after thyroidectomy	No
Primary	Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy	numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable	48 hours after thyroidectomy	No