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

NCT ID: NCT02012686

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-02-28

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.

Conditions

Thyroid Cancer; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

numerical rating scale of TENS non-applied group

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

TENS group

numerical rating scale of TENS applied group

Group Type: ACTIVE_COMPARATOR

TENS

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Cholhee Park

clinical assisted professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

20131127

Identifier Type: -

Identifier Source: org_study_id