Thyroid CancerNCT02012686
The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy
A study testing TENS in people with Thyroid Cancer and Neck Pain, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Thyroid Cancer, Neck Pain
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing open total thyroidectomy under general anesthesia
- American Society of Anesthesiology physical status I or II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 135-720
About this study
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation for Reduction of 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.
Read the 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
- Being tested
- TENS
- Keywords
- transcutaneous electric nerve stimulation, thyroidectomy, neck pain, pain management
- Medical subject headings
- Thyroid Neoplasms, Neck Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | numerical rating scale of TENS non-applied group |
| TENS group | Active comparator | numerical rating scale of TENS applied group Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours after thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cholhee Park, Yonsei University
- Investigators
- Don Woo Han, M.D.,ph.D., 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012686
- Sponsor's protocol ID
- 20131127
- Status last verified
- May 2014
- First submitted
- 4 Dec 2013
- Last updated
- 11 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation for Reduction of Posterior Neck Pain After Thyroidectomy
- ClinicalTrials.gov ID
- NCT02012686
- Acronym / sponsor ID
- 20131127
- Conditions
- Thyroid Cancer, Neck Pain
- Keywords
- transcutaneous electric nerve stimulation, thyroidectomy, neck pain, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | –numerical rating scale of TENS non-applied group |
| TENS group | Active comparator | Device: TENSnumerical rating scale of TENS applied group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Undergoing open total thyroidectomy under general anesthesia
- American Society of Anesthesiology physical status I or II
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSAlso: LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)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 | Device | TENS group |
Primary outcome
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Woo Han, M.D.,ph.D. 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Thyroid Cancer and Neck Pain, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy (time frame: 0.5 hours after thyroidectomy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.