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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Thyroid Cancer, Neck Pain

Intervention / Treatment
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* Device: TENS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>numerical rating scale of TENS non-applied group | |
| Active Comparator: TENS group<br>numerical rating scale of TENS applied group | Device: TENS<br>* 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<br>* Other names: LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, transcutaneous electric nerve stimulation, thyroidectomy, neck pain