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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | numerical rating scale of TENS non-applied group | |
| TENS group | Active Comparator | numerical rating scale of TENS applied group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Woo Han, M.D.,ph.D. | 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul | 135-720 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | numerical rating scale of TENS non-applied group |
| FG001 | TENS Group | numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | numerical rating scale of TENS non-applied group |
| BG001 | TENS Group | numerical rating scale of TENS applied group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Full Range | scores on a scale | 0.5 hours after thyroidectomy |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | numerical rating scale of TENS non-applied group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Dong Woo Han | 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 | 82-2-2019-3549 | HANESTH@yuhs.ac |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D019547 | Neck Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Neck extension time | neck extension time: neck extension position time for thyroidectomy (Just after general anesthesia, the neck of patient was extended. The position was kept before awakening) | Mean | Standard Deviation | minutes |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | scores on a scale | 6 hours after thyroidectomy |
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | scores on a scale | 24 hours after thyroidectomy |
|
|
|
| Primary | 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 | Posted | Median | Full Range | scores on a scale | 48 hours after thyroidectomy |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | TENS Group | numerical rating scale of TENS applied group TENS: transcutaneous electric nerve stimulation | 0 | 50 | 0 | 50 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |