Neck Pain, Thyroid Cancer
Conditions
Keywords
transcutaneous electric nerve stimulation, thyroidectomy, neck pain, pain management
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.
Interventions
DEVICETENS
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
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy | 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 | 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 | 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 | 48 hours after thyroidectomy | numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group numerical rating scale of TENS non-applied group | 50 |
| TENS Group numerical rating scale of TENS applied group | 48 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | electrocardiography monitoring noise | 0 | 1 |
| Overall Study | muscle contraction | 0 | 1 |
Baseline characteristics
| Characteristic | TENS Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 9 | 44 years STANDARD_DEVIATION 10 | 44 years STANDARD_DEVIATION 10 |
| Body mass index | 23 kg/m^2 STANDARD_DEVIATION 3 | 23 kg/m^2 STANDARD_DEVIATION 3 | 23 kg/m^2 STANDARD_DEVIATION 3 |
| Neck extension time | 81 minutes STANDARD_DEVIATION 31 | 80 minutes STANDARD_DEVIATION 28 | 80 minutes STANDARD_DEVIATION 25 |
| Region of Enrollment Korea, Republic of | 48 participants | 98 participants | 50 participants |
| Sex: Female, Male Female | 48 Participants | 98 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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
Time frame: 0.5 hours after thyroidectomy
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy | Inter-Quatile Range | 3.5 scores on a scale |
| Control Group | Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy | Full Range | 3.5 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy | Inter-Quatile Range | 0 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy | Full Range | 0 scores on a scale |
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
Time frame: 24 hours after thyroidectomy
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy | Inter-Quatile Range | 3 scores on a scale |
| Control Group | Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy | Full Range | 3 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy | Inter-Quatile Range | 1 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy | Full Range | 1 scores on a scale |
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
Time frame: 48 hours after thyroidectomy
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy | Inter-Quatile Range | 2 scores on a scale |
| Control Group | Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy | Full Range | 2 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy | Full Range | 0 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy | Inter-Quatile Range | 0 scores on a scale |
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
Time frame: 6 hours after thyroidectomy
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy | Inter-Quatile Range | 4 scores on a scale |
| Control Group | Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy | Full Range | 4 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy | Inter-Quatile Range | 2 scores on a scale |
| TENS Group | Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy | Full Range | 2 scores on a scale |