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

Primary Purpose

Thyroid Cancer, Neck Pain

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

TENS

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring transcutaneous electric nerve stimulation, thyroidectomy, neck pain, pain management

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

TENS group

Arm Description

numerical rating scale of TENS non-applied group

numerical rating scale of TENS applied group

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02012686

First Posted

December 4, 2013

Last Updated

May 12, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02012686

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Cancer, Neck Pain

Keywords

transcutaneous electric nerve stimulation, thyroidectomy, neck pain, pain management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

numerical rating scale of TENS non-applied group

Arm Title

TENS group

Arm Type

Active Comparator

Arm Description

numerical rating scale of TENS applied group

Intervention Type

Device

Intervention Name(s)

TENS

Other Intervention Name(s)

LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)

Intervention Description

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

Primary Outcome Measure Information:

Title

Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy

Description

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Time Frame

0.5 hours after thyroidectomy

Title

Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy

Description

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Time Frame

6 hours after thyroidectomy

Title

Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy

Description

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Time Frame

24 hours after thyroidectomy

Title

Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy

Description

numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable

Time Frame

48 hours after thyroidectomy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Don Woo Han, M.D.,ph.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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