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NCT Number: NCT02012686

The Effect of Transcutaneous Electrical Nerve Stimulation on 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.

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Key information

Conditions

Thyroid Cancer Agnosia Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neck Pain Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Thyroid Diseases Thyroid Neoplasms

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 135-720, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

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

Other names: LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 16, 2013
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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