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Clinical Trials/NCT02012686
NCT02012686CompletedNot Applicable

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

Yonsei University1 site in 1 country100 target enrollmentStarted: November 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control group

Placebo Comparator

numerical rating scale of TENS non-applied group

TENS group

Active Comparator

numerical rating scale of TENS applied group

Intervention: TENS (Device)

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cholhee Park

clinical assisted professor

Yonsei University

Study Sites (1)

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