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

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Thyroid Cancer
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-720
    • Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): June 11, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: neck pain; thyroidectomy; pain management; transcutaneous electric nerve stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 20131127