NCT02012686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 11, 2014

Completed
Last Updated

June 11, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

December 4, 2013

Results QC Date

February 28, 2014

Last Update Submit

May 12, 2014

Conditions

Thyroid CancerNeck Pain

Keywords

transcutaneous electric nerve stimulationthyroidectomyneck painpain management

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

numerical rating scale of TENS non-applied group

TENS group

ACTIVE COMPARATOR

numerical rating scale of TENS applied group

Device: TENS

Interventions

TENSDEVICE

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

Also known as: LT1061 (Shenzhen Dongdixin Technology, Shenzhen, China)
TENS group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Undergoing open total thyroidectomy under general anesthesia
  • American Society of Anesthesiology physical status I or II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Thyroid NeoplasmsNeck PainAgnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Results Point of Contact

Title
Dr Dong Woo Han
Organization
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
HANESTH@yuhs.ac
82-2-2019-3549

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assisted professor

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 16, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

June 11, 2014

Results First Posted

June 11, 2014

Record last verified: 2014-05

Locations

KR(1)